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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01225562




Registration number
NCT01225562
Ethics application status
Date submitted
9/07/2010
Date registered
21/10/2010
Date last updated
25/01/2016

Titles & IDs
Public title
Prevention of Cardiovascular Events (eg, Death From Heart or Vascular Disease, Heart Attack, or Stroke) in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin
Scientific title
A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multinational Trial, to Assess the Prevention of Thrombotic Events With Ticagrelor Compared to Placebo on a Background of Acetyl Salicylic Acid (ASA) Therapy in Patients With History of Myocardial Infarction
Secondary ID [1] 0 0
2009-017242-30
Secondary ID [2] 0 0
D5132C00001
Universal Trial Number (UTN)
Trial acronym
PEGASUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial Infarction 0 0
Cardiovascular Death 0 0
Atherothrombosis 0 0
Stroke 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ticagrelor 90 mg
Treatment: Drugs - Ticagrelor 60 mg
Treatment: Drugs - Ticagrelor Placebo

Experimental: 1 - Oral Treatment

Experimental: 2 - Oral Treatment

Placebo comparator: 3 - Oral Treatment


Treatment: Drugs: Ticagrelor 90 mg
Oral dose twice a day

Treatment: Drugs: Ticagrelor 60 mg
Oral dose twice a day

Treatment: Drugs: Ticagrelor Placebo
Oral dose twice a day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death), Myocardial Infarction (MI) or Stroke Within 3 Years From Randomization
Timepoint [1] 0 0
Randomization up to 47 months
Primary outcome [2] 0 0
Kaplan-Meier Estimate of the Percentage of Patients Who Experienced a TIMI Major Bleeding Within 3 Years From First Dose of Study Drug Units: Percentage of Patients
Timepoint [2] 0 0
First dosing up to 48 months
Secondary outcome [1] 0 0
Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death) Within 3 Years From Randomization
Timepoint [1] 0 0
Randomization up to 47 months
Secondary outcome [2] 0 0
Kaplan-Meier Estimate of the Percentage of Patients Who Died From Any Cause Within 3 Years From Randomization
Timepoint [2] 0 0
Randomization up to 47 months

Eligibility
Key inclusion criteria
* Person who had a heart attack within 1 - 3 years ago and at least one additional risk factor: Age = 65 years old, Diabetes requiring medication, Documented history of 2nd prior MI (>1 year ago). Angiographic evidence of multivessel CAD, and / or Chronic, non-end stage renal dysfunction.
* Females of child-bearing potential must have a negative pregnancy test at enrollment
* Persons who are currently taking aspirin between 75 and 150 mg once daily
Minimum age
50 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Persons who are being treated with agents inhibiting blood clotting if the agent cannot be stopped at study start
* Persons who have planned coronary, cerebrovascular, or peripheral arterial Revascularization (invasive surgery) at study start
* Persons with known bleeding disorders
* Persons who need chronic oral anticoagulant therapy or chronic low-molecular-weight heparin
* Persons with a history of ischemic stroke
* Persons with a history of intracranial bleeding at any time, a tumor or blood vessel abnormality in the brain and/or spinal cord at any time, a history of surgery involving the brain or spinal cord within the last 5 years, or a history of bleeding from the gastrointestinal tract (eg, esophagus, stomach, colon, rectum) within the last 6 months or a major surgery within the last 30 days.
* Persons considered to be at risk of bradycardic events unless already treated with a permanent pacemaker
* Persons who have had open heart surgery within the past 5 years, unless the person had a heart attack after the surgery
* Persons with known severe liver disease
* Persons with kidney failure requiring dialysis
* Persons with life expectancy < 1 year

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2014
Sample size
Target
Accrual to date
Final
21379
Recruitment in Australia
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- Fremantle
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- Woolloongabba
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Czech Republic
State/province [192] 0 0
Znojmo
Country [193] 0 0
France
State/province [193] 0 0
ABBEVILLE cedex
Country [194] 0 0
France
State/province [194] 0 0
Albi
Country [195] 0 0
France
State/province [195] 0 0
ANGERS Cedex 9
Country [196] 0 0
France
State/province [196] 0 0
Angers
Country [197] 0 0
France
State/province [197] 0 0
Avignon Cedex
Country [198] 0 0
France
State/province [198] 0 0
Bayonne
Country [199] 0 0
France
State/province [199] 0 0
Cannes
Country [200] 0 0
France
State/province [200] 0 0
Creteil
Country [201] 0 0
France
State/province [201] 0 0
Dijon
Country [202] 0 0
France
State/province [202] 0 0
Jossigny
Country [203] 0 0
France
State/province [203] 0 0
La Rochelle Cedex
Country [204] 0 0
France
State/province [204] 0 0
Le Chesnay
Country [205] 0 0
France
State/province [205] 0 0
Le Coudray Cedex
Country [206] 0 0
France
State/province [206] 0 0
Limoges Cedex
Country [207] 0 0
France
State/province [207] 0 0
MARSEILLE Cedex 5
Country [208] 0 0
France
State/province [208] 0 0
Metz Cedex 1
Country [209] 0 0
France
State/province [209] 0 0
NICE Cedex 01
Country [210] 0 0
France
State/province [210] 0 0
NIMES Cedex 9
Country [211] 0 0
France
State/province [211] 0 0
Orléans Cedex 2
Country [212] 0 0
France
State/province [212] 0 0
Paris
Country [213] 0 0
France
State/province [213] 0 0
Pessac
Country [214] 0 0
France
State/province [214] 0 0
Poitiers
Country [215] 0 0
France
State/province [215] 0 0
Toulouse Cedex
Country [216] 0 0
France
State/province [216] 0 0
TOURCOING cedex
Country [217] 0 0
Germany
State/province [217] 0 0
Bad Krozingen
Country [218] 0 0
Germany
State/province [218] 0 0
Bad Mergentheim
Country [219] 0 0
Germany
State/province [219] 0 0
Bad Nauheim
Country [220] 0 0
Germany
State/province [220] 0 0
Berlin
Country [221] 0 0
Germany
State/province [221] 0 0
Bielefeld
Country [222] 0 0
Germany
State/province [222] 0 0
Coburg
Country [223] 0 0
Germany
State/province [223] 0 0
Deggingen
Country [224] 0 0
Germany
State/province [224] 0 0
Dortmund
Country [225] 0 0
Germany
State/province [225] 0 0
Dresden
Country [226] 0 0
Germany
State/province [226] 0 0
Essen
Country [227] 0 0
Germany
State/province [227] 0 0
Esslingen
Country [228] 0 0
Germany
State/province [228] 0 0
Frankfurt
Country [229] 0 0
Germany
State/province [229] 0 0
Hamburg
Country [230] 0 0
Germany
State/province [230] 0 0
Heidelberg
Country [231] 0 0
Germany
State/province [231] 0 0
Kassel
Country [232] 0 0
Germany
State/province [232] 0 0
Kiel
Country [233] 0 0
Germany
State/province [233] 0 0
Leipzig
Country [234] 0 0
Germany
State/province [234] 0 0
Limburg
Country [235] 0 0
Germany
State/province [235] 0 0
Ludwigshafen
Country [236] 0 0
Germany
State/province [236] 0 0
Lübeck
Country [237] 0 0
Germany
State/province [237] 0 0
Mainz
Country [238] 0 0
Germany
State/province [238] 0 0
Mönchengladbach
Country [239] 0 0
Germany
State/province [239] 0 0
Ulm
Country [240] 0 0
Germany
State/province [240] 0 0
Warendorf
Country [241] 0 0
Germany
State/province [241] 0 0
Witten
Country [242] 0 0
Hungary
State/province [242] 0 0
Ballasagyarmat
Country [243] 0 0
Hungary
State/province [243] 0 0
Budapest
Country [244] 0 0
Hungary
State/province [244] 0 0
Békéscsaba
Country [245] 0 0
Hungary
State/province [245] 0 0
Cegléd
Country [246] 0 0
Hungary
State/province [246] 0 0
Debrecen
Country [247] 0 0
Hungary
State/province [247] 0 0
Eger
Country [248] 0 0
Hungary
State/province [248] 0 0
Gyula
Country [249] 0 0
Hungary
State/province [249] 0 0
Kalocsa
Country [250] 0 0
Hungary
State/province [250] 0 0
Kecskemét
Country [251] 0 0
Hungary
State/province [251] 0 0
Mosonmagyaróvár
Country [252] 0 0
Hungary
State/province [252] 0 0
Nyíregyháza
Country [253] 0 0
Hungary
State/province [253] 0 0
Pécs
Country [254] 0 0
Hungary
State/province [254] 0 0
Sopron
Country [255] 0 0
Hungary
State/province [255] 0 0
Szeged
Country [256] 0 0
Hungary
State/province [256] 0 0
Szekszárd
Country [257] 0 0
Hungary
State/province [257] 0 0
Szolnok
Country [258] 0 0
Hungary
State/province [258] 0 0
Székesfehérvár
Country [259] 0 0
Hungary
State/province [259] 0 0
Zalaegerszeg
Country [260] 0 0
Italy
State/province [260] 0 0
Albano Laziale
Country [261] 0 0
Italy
State/province [261] 0 0
Bari
Country [262] 0 0
Italy
State/province [262] 0 0
Benevento
Country [263] 0 0
Italy
State/province [263] 0 0
Brescia
Country [264] 0 0
Italy
State/province [264] 0 0
Carpi
Country [265] 0 0
Italy
State/province [265] 0 0
Catania
Country [266] 0 0
Italy
State/province [266] 0 0
Genova
Country [267] 0 0
Italy
State/province [267] 0 0
Legnano
Country [268] 0 0
Italy
State/province [268] 0 0
Lucca
Country [269] 0 0
Italy
State/province [269] 0 0
Massa
Country [270] 0 0
Italy
State/province [270] 0 0
Milano
Country [271] 0 0
Italy
State/province [271] 0 0
Napoli
Country [272] 0 0
Italy
State/province [272] 0 0
Osio Sotto frazione di Zingoni
Country [273] 0 0
Italy
State/province [273] 0 0
Parma
Country [274] 0 0
Italy
State/province [274] 0 0
Pavia
Country [275] 0 0
Italy
State/province [275] 0 0
Perugia
Country [276] 0 0
Italy
State/province [276] 0 0
Pescara
Country [277] 0 0
Italy
State/province [277] 0 0
Pisa
Country [278] 0 0
Italy
State/province [278] 0 0
Reggio Emilia
Country [279] 0 0
Italy
State/province [279] 0 0
Roma
Country [280] 0 0
Italy
State/province [280] 0 0
Rozzano
Country [281] 0 0
Italy
State/province [281] 0 0
S Maria Capua Vetere
Country [282] 0 0
Italy
State/province [282] 0 0
San Remo
Country [283] 0 0
Italy
State/province [283] 0 0
Sassari
Country [284] 0 0
Italy
State/province [284] 0 0
Sessa Aurunca
Country [285] 0 0
Italy
State/province [285] 0 0
Siena
Country [286] 0 0
Italy
State/province [286] 0 0
Sorrento NA
Country [287] 0 0
Italy
State/province [287] 0 0
Vimercate
Country [288] 0 0
Japan
State/province [288] 0 0
Akishima-shi
Country [289] 0 0
Japan
State/province [289] 0 0
Amagasaki-shi
Country [290] 0 0
Japan
State/province [290] 0 0
Beppu-shi
Country [291] 0 0
Japan
State/province [291] 0 0
Chuo-ku
Country [292] 0 0
Japan
State/province [292] 0 0
Daito-shi
Country [293] 0 0
Japan
State/province [293] 0 0
Fukui-shi
Country [294] 0 0
Japan
State/province [294] 0 0
Funabashi-shi
Country [295] 0 0
Japan
State/province [295] 0 0
Gifu-shi
Country [296] 0 0
Japan
State/province [296] 0 0
Hamamatsu-shi
Country [297] 0 0
Japan
State/province [297] 0 0
Himeji-shi
Country [298] 0 0
Japan
State/province [298] 0 0
Imabari-shi
Country [299] 0 0
Japan
State/province [299] 0 0
Isehara-shi
Country [300] 0 0
Japan
State/province [300] 0 0
Kamogawa-shi
Country [301] 0 0
Japan
State/province [301] 0 0
Kanazawa-shi
Country [302] 0 0
Japan
State/province [302] 0 0
Kawachinagano-shi
Country [303] 0 0
Japan
State/province [303] 0 0
Kisarazu-shi
Country [304] 0 0
Japan
State/province [304] 0 0
Komatsushima-shi
Country [305] 0 0
Japan
State/province [305] 0 0
Koriyama-shi
Country [306] 0 0
Japan
State/province [306] 0 0
Kumamoto-shi
Country [307] 0 0
Japan
State/province [307] 0 0
Kure-shi
Country [308] 0 0
Japan
State/province [308] 0 0
Kusatsu-shi
Country [309] 0 0
Japan
State/province [309] 0 0
Kyoto-shi
Country [310] 0 0
Japan
State/province [310] 0 0
Maebashi-shi
Country [311] 0 0
Japan
State/province [311] 0 0
Matsue-shi
Country [312] 0 0
Japan
State/province [312] 0 0
Matsumoto-shi
Country [313] 0 0
Japan
State/province [313] 0 0
Matsuyama-shi
Country [314] 0 0
Japan
State/province [314] 0 0
Meguro-ku
Country [315] 0 0
Japan
State/province [315] 0 0
Miyazaki-shi
Country [316] 0 0
Japan
State/province [316] 0 0
Osaka-shi
Country [317] 0 0
Japan
State/province [317] 0 0
Saga-shi
Country [318] 0 0
Japan
State/province [318] 0 0
Sagamihara-shi
Country [319] 0 0
Japan
State/province [319] 0 0
Saitama-shi
Country [320] 0 0
Japan
State/province [320] 0 0
Sakai-shi
Country [321] 0 0
Japan
State/province [321] 0 0
Sakaide-shi
Country [322] 0 0
Japan
State/province [322] 0 0
Sapporo-shi
Country [323] 0 0
Japan
State/province [323] 0 0
Sayama-shi
Country [324] 0 0
Japan
State/province [324] 0 0
Shimada-shi
Country [325] 0 0
Japan
State/province [325] 0 0
Shinagawa-ku
Country [326] 0 0
Japan
State/province [326] 0 0
Shizuoka-shi
Country [327] 0 0
Japan
State/province [327] 0 0
Suwa-shi
Country [328] 0 0
Japan
State/province [328] 0 0
Takarazuka-shi
Country [329] 0 0
Japan
State/province [329] 0 0
Takasaki-shi
Country [330] 0 0
Japan
State/province [330] 0 0
Takatsuki-shi
Country [331] 0 0
Japan
State/province [331] 0 0
Tomakomai-shi
Country [332] 0 0
Japan
State/province [332] 0 0
Toyonaka-shi
Country [333] 0 0
Japan
State/province [333] 0 0
Ueda-shi
Country [334] 0 0
Japan
State/province [334] 0 0
Wakayama-shi
Country [335] 0 0
Japan
State/province [335] 0 0
Wako-shi
Country [336] 0 0
Japan
State/province [336] 0 0
Yatsushiro-shi
Country [337] 0 0
Japan
State/province [337] 0 0
Yokohama-shi
Country [338] 0 0
Korea, Republic of
State/province [338] 0 0
Bucheon-si
Country [339] 0 0
Korea, Republic of
State/province [339] 0 0
Busan
Country [340] 0 0
Korea, Republic of
State/province [340] 0 0
Cheongju
Country [341] 0 0
Korea, Republic of
State/province [341] 0 0
Daegu
Country [342] 0 0
Korea, Republic of
State/province [342] 0 0
Daejeon
Country [343] 0 0
Korea, Republic of
State/province [343] 0 0
Gwangju
Country [344] 0 0
Korea, Republic of
State/province [344] 0 0
Jeonju
Country [345] 0 0
Korea, Republic of
State/province [345] 0 0
Seongnam-si
Country [346] 0 0
Korea, Republic of
State/province [346] 0 0
Seoul
Country [347] 0 0
Korea, Republic of
State/province [347] 0 0
Suwon-si
Country [348] 0 0
Korea, Republic of
State/province [348] 0 0
Uijeongbu
Country [349] 0 0
Korea, Republic of
State/province [349] 0 0
Wonju-si
Country [350] 0 0
Netherlands
State/province [350] 0 0
Almere
Country [351] 0 0
Netherlands
State/province [351] 0 0
Amersfoort
Country [352] 0 0
Netherlands
State/province [352] 0 0
Amsterdam
Country [353] 0 0
Netherlands
State/province [353] 0 0
Arnhem
Country [354] 0 0
Netherlands
State/province [354] 0 0
Beverwijk
Country [355] 0 0
Netherlands
State/province [355] 0 0
Breda
Country [356] 0 0
Netherlands
State/province [356] 0 0
Delft
Country [357] 0 0
Netherlands
State/province [357] 0 0
Den Haag
Country [358] 0 0
Netherlands
State/province [358] 0 0
Den Helder
Country [359] 0 0
Netherlands
State/province [359] 0 0
Deventer
Country [360] 0 0
Netherlands
State/province [360] 0 0
Drachten
Country [361] 0 0
Netherlands
State/province [361] 0 0
EDE
Country [362] 0 0
Netherlands
State/province [362] 0 0
Eindhoven
Country [363] 0 0
Netherlands
State/province [363] 0 0
Goes
Country [364] 0 0
Netherlands
State/province [364] 0 0
Groningen
Country [365] 0 0
Netherlands
State/province [365] 0 0
Hardenberg
Country [366] 0 0
Netherlands
State/province [366] 0 0
Heerenveen
Country [367] 0 0
Netherlands
State/province [367] 0 0
Heerlen
Country [368] 0 0
Netherlands
State/province [368] 0 0
Helmond
Country [369] 0 0
Netherlands
State/province [369] 0 0
Hilversum
Country [370] 0 0
Netherlands
State/province [370] 0 0
Hoofddorp
Country [371] 0 0
Netherlands
State/province [371] 0 0
Hoogeveen
Country [372] 0 0
Netherlands
State/province [372] 0 0
Leiderdorp
Country [373] 0 0
Netherlands
State/province [373] 0 0
Maastricht
Country [374] 0 0
Netherlands
State/province [374] 0 0
Nieuwegein
Country [375] 0 0
Netherlands
State/province [375] 0 0
Nijmegen
Country [376] 0 0
Netherlands
State/province [376] 0 0
OSS
Country [377] 0 0
Netherlands
State/province [377] 0 0
Roosendaal
Country [378] 0 0
Netherlands
State/province [378] 0 0
Rotterdam
Country [379] 0 0
Netherlands
State/province [379] 0 0
Schiedam
Country [380] 0 0
Netherlands
State/province [380] 0 0
Shertogenbosch
Country [381] 0 0
Netherlands
State/province [381] 0 0
Sittardgeleen
Country [382] 0 0
Netherlands
State/province [382] 0 0
Sneek
Country [383] 0 0
Netherlands
State/province [383] 0 0
Tiel
Country [384] 0 0
Netherlands
State/province [384] 0 0
Tilburg
Country [385] 0 0
Netherlands
State/province [385] 0 0
Veldhoven
Country [386] 0 0
Norway
State/province [386] 0 0
Bergen
Country [387] 0 0
Norway
State/province [387] 0 0
Bodo
Country [388] 0 0
Norway
State/province [388] 0 0
Bodø
Country [389] 0 0
Norway
State/province [389] 0 0
Flekkefjord
Country [390] 0 0
Norway
State/province [390] 0 0
Hamar
Country [391] 0 0
Norway
State/province [391] 0 0
Levanger
Country [392] 0 0
Norway
State/province [392] 0 0
Lillehammer
Country [393] 0 0
Norway
State/province [393] 0 0
Nesttun
Country [394] 0 0
Norway
State/province [394] 0 0
Oslo
Country [395] 0 0
Norway
State/province [395] 0 0
Skien
Country [396] 0 0
Norway
State/province [396] 0 0
Tromsø
Country [397] 0 0
Norway
State/province [397] 0 0
Tynset
Country [398] 0 0
Peru
State/province [398] 0 0
Arequipa
Country [399] 0 0
Peru
State/province [399] 0 0
Callao
Country [400] 0 0
Peru
State/province [400] 0 0
Lima
Country [401] 0 0
Peru
State/province [401] 0 0
San Borja
Country [402] 0 0
Peru
State/province [402] 0 0
Trujillo
Country [403] 0 0
Philippines
State/province [403] 0 0
Cebu City
Country [404] 0 0
Philippines
State/province [404] 0 0
Fuente Osmena Cebu City
Country [405] 0 0
Philippines
State/province [405] 0 0
Iloilo City
Country [406] 0 0
Philippines
State/province [406] 0 0
Las Pinas City
Country [407] 0 0
Philippines
State/province [407] 0 0
Lipa City
Country [408] 0 0
Philippines
State/province [408] 0 0
Mandaluyong City
Country [409] 0 0
Philippines
State/province [409] 0 0
Manila
Country [410] 0 0
Philippines
State/province [410] 0 0
Pasig City
Country [411] 0 0
Philippines
State/province [411] 0 0
Quezon City
Country [412] 0 0
Philippines
State/province [412] 0 0
Quezon
Country [413] 0 0
Philippines
State/province [413] 0 0
San Juan
Country [414] 0 0
Poland
State/province [414] 0 0
Bialystok
Country [415] 0 0
Poland
State/province [415] 0 0
Bielsko Biala
Country [416] 0 0
Poland
State/province [416] 0 0
Bydgoszcz
Country [417] 0 0
Poland
State/province [417] 0 0
Chorzow
Country [418] 0 0
Poland
State/province [418] 0 0
Gdansk
Country [419] 0 0
Poland
State/province [419] 0 0
Gdynia
Country [420] 0 0
Poland
State/province [420] 0 0
Gizycko
Country [421] 0 0
Poland
State/province [421] 0 0
Kraków
Country [422] 0 0
Poland
State/province [422] 0 0
Legnica
Country [423] 0 0
Poland
State/province [423] 0 0
Lubin
Country [424] 0 0
Poland
State/province [424] 0 0
Nowa Sól
Country [425] 0 0
Poland
State/province [425] 0 0
Olsztyn
Country [426] 0 0
Poland
State/province [426] 0 0
Opole
Country [427] 0 0
Poland
State/province [427] 0 0
Ostrów Mazowiecka
Country [428] 0 0
Poland
State/province [428] 0 0
Olawa
Country [429] 0 0
Poland
State/province [429] 0 0
Piotrkow
Country [430] 0 0
Poland
State/province [430] 0 0
Poznan
Country [431] 0 0
Poland
State/province [431] 0 0
Plock
Country [432] 0 0
Poland
State/province [432] 0 0
Skierniewice
Country [433] 0 0
Poland
State/province [433] 0 0
Sobótka
Country [434] 0 0
Poland
State/province [434] 0 0
Sokolka
Country [435] 0 0
Poland
State/province [435] 0 0
Szczecin
Country [436] 0 0
Poland
State/province [436] 0 0
Tarnów
Country [437] 0 0
Poland
State/province [437] 0 0
Torun
Country [438] 0 0
Poland
State/province [438] 0 0
Warszawa
Country [439] 0 0
Poland
State/province [439] 0 0
Wroclaw
Country [440] 0 0
Poland
State/province [440] 0 0
Wloclawek
Country [441] 0 0
Poland
State/province [441] 0 0
Lancut
Country [442] 0 0
Poland
State/province [442] 0 0
Lódz
Country [443] 0 0
Poland
State/province [443] 0 0
Leczna
Country [444] 0 0
Romania
State/province [444] 0 0
Bacau
Country [445] 0 0
Romania
State/province [445] 0 0
Braila
Country [446] 0 0
Romania
State/province [446] 0 0
Brasov
Country [447] 0 0
Romania
State/province [447] 0 0
Bucharest
Country [448] 0 0
Romania
State/province [448] 0 0
Bucuresti
Country [449] 0 0
Romania
State/province [449] 0 0
Buzau
Country [450] 0 0
Romania
State/province [450] 0 0
Cluj Napoca
Country [451] 0 0
Romania
State/province [451] 0 0
Craiova
Country [452] 0 0
Romania
State/province [452] 0 0
Deva
Country [453] 0 0
Romania
State/province [453] 0 0
Focsani
Country [454] 0 0
Romania
State/province [454] 0 0
Iasi
Country [455] 0 0
Romania
State/province [455] 0 0
Pitesti
Country [456] 0 0
Romania
State/province [456] 0 0
Sibiu
Country [457] 0 0
Romania
State/province [457] 0 0
Suceava
Country [458] 0 0
Romania
State/province [458] 0 0
Tg. Mures
Country [459] 0 0
Romania
State/province [459] 0 0
Timisoara
Country [460] 0 0
Russian Federation
State/province [460] 0 0
Ekaterinburg
Country [461] 0 0
Russian Federation
State/province [461] 0 0
Gatchina
Country [462] 0 0
Russian Federation
State/province [462] 0 0
Kazan
Country [463] 0 0
Russian Federation
State/province [463] 0 0
Krasnodar
Country [464] 0 0
Russian Federation
State/province [464] 0 0
Moscow
Country [465] 0 0
Russian Federation
State/province [465] 0 0
Nizhnii Novgorod
Country [466] 0 0
Russian Federation
State/province [466] 0 0
Novosibirsk
Country [467] 0 0
Russian Federation
State/province [467] 0 0
Perm
Country [468] 0 0
Russian Federation
State/province [468] 0 0
Saint Petersburg
Country [469] 0 0
Russian Federation
State/province [469] 0 0
Saint-Petersburg
Country [470] 0 0
Russian Federation
State/province [470] 0 0
Saratov
Country [471] 0 0
Russian Federation
State/province [471] 0 0
St.-Petersburg,
Country [472] 0 0
Russian Federation
State/province [472] 0 0
St.-Petersburg
Country [473] 0 0
Russian Federation
State/province [473] 0 0
St.Petersburg
Country [474] 0 0
Russian Federation
State/province [474] 0 0
StPetersburg
Country [475] 0 0
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is being carried out to see if a new drug called ticagrelor given twice daily in addition to the ASA therapy decreases the frequency of cardiovascular events (e.g., death from heart disease, heart attack, or stroke).
Trial website
https://clinicaltrials.gov/study/NCT01225562
Trial related presentations / publications
Bonaca MP, Bhatt DL, Cohen M, Steg PG, Storey RF, Jensen EC, Magnani G, Bansilal S, Fish MP, Im K, Bengtsson O, Oude Ophuis T, Budaj A, Theroux P, Ruda M, Hamm C, Goto S, Spinar J, Nicolau JC, Kiss RG, Murphy SA, Wiviott SD, Held P, Braunwald E, Sabatine MS; PEGASUS-TIMI 54 Steering Committee and Investigators. Long-term use of ticagrelor in patients with prior myocardial infarction. N Engl J Med. 2015 May 7;372(19):1791-800. doi: 10.1056/NEJMoa1500857. Epub 2015 Mar 14.
Bonaca MP, Im K, Magnani G, Bansilal S, Dellborg M, Storey RF, Bhatt DL, Steg PG, Cohen M, Johanson P, Braunwald E, Sabatine MS. Patient selection for long-term secondary prevention with ticagrelor: insights from PEGASUS-TIMI 54. Eur Heart J. 2022 Dec 21;43(48):5037-5044. doi: 10.1093/eurheartj/ehac402.
Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
Bergmark BA, Bhatt DL, Steg PG, Budaj A, Storey RF, Gurmu Y, Kuder JF, Im K, Magnani G, Oude Ophuis T, Hamm C, Spinar J, Kiss RG, Van de Werf FJ, Montalescot G, Johanson P, Braunwald E, Sabatine MS, Bonaca MP. Long-Term Ticagrelor in Patients With Prior Coronary Stenting in the PEGASUS-TIMI 54 Trial. J Am Heart Assoc. 2021 Sep 7;10(17):e020446. doi: 10.1161/JAHA.120.020446. Epub 2021 Aug 21.
Magnani G, Ardissino D, Im K, Budaj A, Storey RF, Steg PG, Bhatt DL, Cohen M, Oude Ophius T, Goudev A, Parkhomenko A, Kamensky G, Angiolillo DJ, Lopez-Sendon J, Johanson P, Braunwald E, Sabatine MS, Bonaca MP. Predictors, Type, and Impact of Bleeding on the Net Clinical Benefit of Long-Term Ticagrelor in Stable Patients With Prior Myocardial Infarction. J Am Heart Assoc. 2021 Feb 16;10(4):e017008. doi: 10.1161/JAHA.120.017008. Epub 2021 Feb 9.
Furtado RHM, Venkateswaran RV, Nicolau JC, Gurmu Y, Bhatt DL, Storey RF, Steg PG, Magnani G, Goto S, Dellborg M, Kamensky G, Isaza D, Aylward P, Johanson P, Bonaca MP. Caffeinated Beverage Intake, Dyspnea With Ticagrelor, and Cardiovascular Outcomes: Insights From the PEGASUS-TIMI 54 Trial. J Am Heart Assoc. 2020 May 18;9(10):e015785. doi: 10.1161/JAHA.119.015785. Epub 2020 May 15.
Gencer B, Li XS, Gurmu Y, Bonaca MP, Morrow DA, Cohen M, Bhatt DL, Steg PG, Storey RF, Johanson P, Wang Z, Hazen SL, Sabatine MS. Gut Microbiota-Dependent Trimethylamine N-oxide and Cardiovascular Outcomes in Patients With Prior Myocardial Infarction: A Nested Case Control Study From the PEGASUS-TIMI 54 Trial. J Am Heart Assoc. 2020 May 18;9(10):e015331. doi: 10.1161/JAHA.119.015331. Epub 2020 May 5.
Furtado RHM, Nicolau JC, Magnani G, Im K, Bhatt DL, Storey RF, Steg PG, Spinar J, Budaj A, Kontny F, Corbalan R, Kiss RG, Abola MT, Johanson P, Jensen EC, Braunwald E, Sabatine MS, Bonaca MP. Long-term ticagrelor for secondary prevention in patients with prior myocardial infarction and no history of coronary stenting: insights from PEGASUS-TIMI 54. Eur Heart J. 2020 May 1;41(17):1625-1632. doi: 10.1093/eurheartj/ehz821.
Dellborg M, Bonaca MP, Storey RF, Steg PG, Im KA, Cohen M, Bhatt DL, Oude Ophuis T, Budaj A, Hamm C, Spinar J, Kiss RG, Lopez-Sendon J, Kamensky G, Van de Werf F, Ardissino D, Kontny F, Montalescot G, Johanson P, Bengtsson O, Himmelmann A, Braunwald E, Sabatine MS. Efficacy and safety with ticagrelor in patients with prior myocardial infarction in the approved European label: insights from PEGASUS-TIMI 54. Eur Heart J Cardiovasc Pharmacother. 2019 Oct 1;5(4):200-206. doi: 10.1093/ehjcvp/pvz020.
Bonaca MP, Wiviott SD, Morrow DA, Steg PG, Hamm C, Bhatt DL, Storey RF, Cohen M, Kuder J, Im K, Magnani G, Budaj A, Nicolau JC, Parkhomenko A, Lopez-Sendon J, Dellborg M, Diaz R, Van de Werf F, Corbalan R, Goudev A, Jensen EC, Johanson P, Braunwald E, Sabatine MS. Reduction in Subtypes and Sizes of Myocardial Infarction With Ticagrelor in PEGASUS-TIMI 54. J Am Heart Assoc. 2018 Nov 20;7(22):e009260. doi: 10.1161/JAHA.118.009260.
Bansilal S, Bonaca MP, Cornel JH, Storey RF, Bhatt DL, Steg PG, Im K, Murphy SA, Angiolillo DJ, Kiss RG, Parkhomenko AN, Lopez-Sendon J, Isaza D, Goudev A, Kontny F, Held P, Jensen EC, Braunwald E, Sabatine MS, Oude Ophuis AJ. Ticagrelor for Secondary Prevention of Atherothrombotic Events in Patients With Multivessel Coronary Disease. J Am Coll Cardiol. 2018 Feb 6;71(5):489-496. doi: 10.1016/j.jacc.2017.11.050.
Cavallari I, Morrow DA, Creager MA, Olin J, Bhatt DL, Steg PG, Storey RF, Cohen M, Scirica BS, Piazza G, Goodrich EL, Braunwald E, Sabatine MS, Bonaca MP. Frequency, Predictors, and Impact of Combined Antiplatelet Therapy on Venous Thromboembolism in Patients With Symptomatic Atherosclerosis. Circulation. 2018 Feb 13;137(7):684-692. doi: 10.1161/CIRCULATIONAHA.117.031062. Epub 2017 Oct 30.
Bonaca MP, Storey RF, Theroux P, Steg PG, Bhatt DL, Cohen MC, Im K, Murphy SA, Magnani G, Ophuis TO, Rudah M, Parkhomenko A, Isaza D, Kamensky G, Goudev A, Montalescot G, Jensen EC, Johanson P, Braunwald E, Sabatine MS. Efficacy and Safety of Ticagrelor Over Time in Patients With Prior MI in PEGASUS-TIMI 54. J Am Coll Cardiol. 2017 Sep 12;70(11):1368-1375. doi: 10.1016/j.jacc.2017.07.768.
Magnuson EA, Li H, Wang K, Vilain K, Shafiq A, Bonaca MP, Bhatt DL, Cohen M, Steg PG, Storey RF, Braunwald E, Sabatine MS, Cohen DJ; PEGASUS-TIMI 54 Trial Investigators. Cost-Effectiveness of Long-Term Ticagrelor in Patients With Prior Myocardial Infarction: Results From the PEGASUS-TIMI 54 Trial. J Am Coll Cardiol. 2017 Aug 1;70(5):527-538. doi: 10.1016/j.jacc.2017.05.063.
Thomas MR, Angiolillo DJ, Bonaca MP, Ajjan RA, Judge HM, Rollini F, Franchi F, Ahsan AJ, Bhatt DL, Kuder JF, Steg PG, Cohen M, Muthusamy R, Sabatine MS, Storey RF. Consistent platelet inhibition with ticagrelor 60 mg twice-daily following myocardial infarction regardless of diabetes status. Thromb Haemost. 2017 May 3;117(5):940-947. doi: 10.1160/TH16-09-0703. Epub 2017 Mar 16.
Bonaca MP, Goto S, Bhatt DL, Steg PG, Storey RF, Cohen M, Goodrich E, Mauri L, Ophuis TO, Ruda M, Spinar J, Seung KB, Hu D, Dalby AJ, Jensen E, Held P, Morrow DA, Braunwald E, Sabatine MS. Prevention of Stroke with Ticagrelor in Patients with Prior Myocardial Infarction: Insights from PEGASUS-TIMI 54 (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54). Circulation. 2016 Sep 20;134(12):861-71. doi: 10.1161/CIRCULATIONAHA.116.024637. Epub 2016 Aug 30.
Bonaca MP, Bhatt DL, Oude Ophuis T, Steg PG, Storey R, Cohen M, Kuder J, Im K, Magnani G, Budaj A, Theroux P, Hamm C, Spinar J, Kiss RG, Dalby AJ, Medina FA, Kontny F, Aylward PE, Jensen EC, Held P, Braunwald E, Sabatine MS. Long-term Tolerability of Ticagrelor for the Secondary Prevention of Major Adverse Cardiovascular Events: A Secondary Analysis of the PEGASUS-TIMI 54 Trial. JAMA Cardiol. 2016 Jul 1;1(4):425-32. doi: 10.1001/jamacardio.2016.1017.
Held P, Himmelmann A, Ditmarsch M. Ticagrelor for the treatment of atherosclerotic disease: insights from the PARTHENON clinical development program. Future Cardiol. 2016 Jul;12(4):405-18. doi: 10.2217/fca-2016-0028. Epub 2016 May 10.
Bonaca MP, Bhatt DL, Storey RF, Steg PG, Cohen M, Kuder J, Goodrich E, Nicolau JC, Parkhomenko A, Lopez-Sendon J, Dellborg M, Dalby A, Spinar J, Aylward P, Corbalan R, Abola MTB, Jensen EC, Held P, Braunwald E, Sabatine MS. Ticagrelor for Prevention of Ischemic Events After Myocardial Infarction in Patients With Peripheral Artery Disease. J Am Coll Cardiol. 2016 Jun 14;67(23):2719-2728. doi: 10.1016/j.jacc.2016.03.524. Epub 2016 Apr 1.
Bhatt DL, Bonaca MP, Bansilal S, Angiolillo DJ, Cohen M, Storey RF, Im K, Murphy SA, Held P, Braunwald E, Sabatine MS, Steg PG. Reduction in Ischemic Events With Ticagrelor in Diabetic Patients With Prior Myocardial Infarction in PEGASUS-TIMI 54. J Am Coll Cardiol. 2016 Jun 14;67(23):2732-2740. doi: 10.1016/j.jacc.2016.03.529. Epub 2016 Apr 1.
Bonaca MP, Bhatt DL, Steg PG, Storey RF, Cohen M, Im K, Oude Ophuis T, Budaj A, Goto S, Lopez-Sendon J, Diaz R, Dalby A, Van de Werf F, Ardissino D, Montalescot G, Aylward P, Magnani G, Jensen EC, Held P, Braunwald E, Sabatine MS. Ischaemic risk and efficacy of ticagrelor in relation to time from P2Y12 inhibitor withdrawal in patients with prior myocardial infarction: insights from PEGASUS-TIMI 54. Eur Heart J. 2016 Apr 7;37(14):1133-42. doi: 10.1093/eurheartj/ehv531. Epub 2015 Oct 21.
Bonaca MP, Bhatt DL, Braunwald E, Cohen M, Steg PG, Storey RF, Held P, Jensen EC, Sabatine MS. Design and rationale for the Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54 (PEGASUS-TIMI 54) trial. Am Heart J. 2014 Apr;167(4):437-444.e5. doi: 10.1016/j.ahj.2013.12.020. Epub 2014 Jan 6.
Public notes

Contacts
Principal investigator
Name 0 0
Eugene Braunwald, MD
Address 0 0
TIMI Study Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01225562