Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01813435




Registration number
NCT01813435
Ethics application status
Date submitted
12/02/2013
Date registered
19/03/2013
Date last updated
15/03/2022

Titles & IDs
Public title
GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation
Scientific title
GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation
Secondary ID [1] 0 0
ECRI-12-001, 02EU11
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease (CAD) 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ticagrelor
Treatment: Drugs - Acetylsalicylic Acid
Treatment: Drugs - Clopidogrel

Experimental: Experimental treatment strategy - All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.

Dosage and frequency:

Ticagrelor: 90 mg b.i.d. ASA: of 75mg qd (- = 100 mg qd)

Active comparator: Reference treatment strategy - Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.

Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.

Dosage and frequency:

Brilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- = 100 mg qd) Clopidogrel: 75 mg qd


Treatment: Drugs: Ticagrelor
Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.

Treatment: Drugs: Acetylsalicylic Acid
Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy

Treatment: Drugs: Clopidogrel
Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.

Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With a Composite of All-cause Mortality or Non-fatal New Q-wave Myocardial Infarction (MI)
Timepoint [1] 0 0
2 year
Secondary outcome [1] 0 0
Number of Participants With All-cause Mortality
Timepoint [1] 0 0
2-year
Secondary outcome [2] 0 0
Number of Participants With Myocardial Infarction
Timepoint [2] 0 0
2 year
Secondary outcome [3] 0 0
Number of Participants With New Q-wave Myocardial Infarction
Timepoint [3] 0 0
2-year
Secondary outcome [4] 0 0
Number of Participants With a Composite of All-cause Mortality, Stroke, or New Q-wave Myocardial Infarction
Timepoint [4] 0 0
2-year
Secondary outcome [5] 0 0
Number of Participants With a Stroke
Timepoint [5] 0 0
2 year
Secondary outcome [6] 0 0
Number of Participants With a Myocardial Revascularisation
Timepoint [6] 0 0
2 year
Secondary outcome [7] 0 0
Number of Participants With a Definite Stent Thrombosis
Timepoint [7] 0 0
2 year
Secondary outcome [8] 0 0
Number of Participants With a Bleeding Academic Research Consortium (BARC) 3 or 5 Bleeding
Timepoint [8] 0 0
2 year

Eligibility
Key inclusion criteria
-"All comer" patients

1. Age =18 years;
2. Presence of one or more coronary artery stenoses of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation. The vessel should have a reference vessel diameter of at least 2.25 mm (no limitation on the number of treated lesions, vessels, or lesion length);
3. Able to provide informed consent and willing to participate in 2 year follow- up period.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known intolerance to aspirin, P2Y12 inhibitors, bivalirudin, stainless steel or biolimus;
2. Known intake of a strong CYP3A4 inhibitor (e.g., ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir), as co-administration may lead to a substantial increase in exposure to ticagrelor;
3. Known moderate to severe hepatic impairment (alanine-aminotransferase = 3 x ULN);
4. Planned surgery, including coronary artery bypass graft (CABG) as a staged procedure (hybrid) within 12 months of the index procedure, unless dual antiplatelet therapy is maintained throughout the peri-surgical period;
5. Need for chronic oral anti-coagulation therapy;
6. Active major bleeding or major surgery within the last 30 days;
7. Known history of intracranial haemorrhagic stroke or intra-cranial aneurysm;
8. Known stroke (any type) within the last 30 days;
9. Known pregnancy at time of randomisation;
10. Female who is breastfeeding at time of randomisation;
11. Currently participating in another trial and not yet at its primary endpoint.

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



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
1/07/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/04/2018
Sample size
Target
Accrual to date
Final
15991
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research centre Brisbane, 6101 - Brisbane
Recruitment hospital [2] 0 0
Research centre Melbourne, 6104 - Melbourne
Recruitment hospital [3] 0 0
Research centre Melbourne, 6105 - Melbourne
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Innsbruck
Country [3] 0 0
Austria
State/province [3] 0 0
Linz
Country [4] 0 0
Austria
State/province [4] 0 0
Vienna
Country [5] 0 0
Belgium
State/province [5] 0 0
Aalst
Country [6] 0 0
Belgium
State/province [6] 0 0
Bonheiden
Country [7] 0 0
Belgium
State/province [7] 0 0
Charleroi
Country [8] 0 0
Belgium
State/province [8] 0 0
Genk
Country [9] 0 0
Belgium
State/province [9] 0 0
Hasselt
Country [10] 0 0
Brazil
State/province [10] 0 0
Rio de Janeiro
Country [11] 0 0
Brazil
State/province [11] 0 0
Sao Paulo
Country [12] 0 0
Brazil
State/province [12] 0 0
Uberlândia
Country [13] 0 0
Bulgaria
State/province [13] 0 0
Burgas
Country [14] 0 0
Bulgaria
State/province [14] 0 0
Plovdiv
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Sofia
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Varna
Country [17] 0 0
Canada
State/province [17] 0 0
Newmarket
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
Denmark
State/province [19] 0 0
Copenhagen
Country [20] 0 0
Denmark
State/province [20] 0 0
Roskilde
Country [21] 0 0
France
State/province [21] 0 0
Aix en Provence
Country [22] 0 0
France
State/province [22] 0 0
Caen
Country [23] 0 0
France
State/province [23] 0 0
Clermont-Ferrand
Country [24] 0 0
France
State/province [24] 0 0
Dijon
Country [25] 0 0
France
State/province [25] 0 0
Grenoble Cedex
Country [26] 0 0
France
State/province [26] 0 0
Lyon
Country [27] 0 0
France
State/province [27] 0 0
Nancy
Country [28] 0 0
France
State/province [28] 0 0
Paris
Country [29] 0 0
France
State/province [29] 0 0
Rouen
Country [30] 0 0
France
State/province [30] 0 0
Saint Etienne
Country [31] 0 0
France
State/province [31] 0 0
Toulouse
Country [32] 0 0
Germany
State/province [32] 0 0
Bad Krozingen
Country [33] 0 0
Germany
State/province [33] 0 0
Bad Nauheim
Country [34] 0 0
Germany
State/province [34] 0 0
Berlin
Country [35] 0 0
Germany
State/province [35] 0 0
Bonn
Country [36] 0 0
Germany
State/province [36] 0 0
Dresden
Country [37] 0 0
Germany
State/province [37] 0 0
Essen
Country [38] 0 0
Germany
State/province [38] 0 0
Fulda
Country [39] 0 0
Germany
State/province [39] 0 0
Giessen
Country [40] 0 0
Germany
State/province [40] 0 0
Göttingen
Country [41] 0 0
Germany
State/province [41] 0 0
Landshut
Country [42] 0 0
Germany
State/province [42] 0 0
Lubeck
Country [43] 0 0
Germany
State/province [43] 0 0
Mainz
Country [44] 0 0
Germany
State/province [44] 0 0
Mannheim
Country [45] 0 0
Germany
State/province [45] 0 0
Mönchengladbach
Country [46] 0 0
Germany
State/province [46] 0 0
Neuss
Country [47] 0 0
Germany
State/province [47] 0 0
Tubingen
Country [48] 0 0
Germany
State/province [48] 0 0
Villingen - Schwenningen
Country [49] 0 0
Hungary
State/province [49] 0 0
Balatonfüred
Country [50] 0 0
Hungary
State/province [50] 0 0
Budapest
Country [51] 0 0
Hungary
State/province [51] 0 0
Debrecen
Country [52] 0 0
Hungary
State/province [52] 0 0
Gyula
Country [53] 0 0
Hungary
State/province [53] 0 0
Nyíregyháza
Country [54] 0 0
Hungary
State/province [54] 0 0
Pécs
Country [55] 0 0
Hungary
State/province [55] 0 0
Szeged
Country [56] 0 0
Italy
State/province [56] 0 0
Arezzo
Country [57] 0 0
Italy
State/province [57] 0 0
Brescia
Country [58] 0 0
Italy
State/province [58] 0 0
Ferrara
Country [59] 0 0
Italy
State/province [59] 0 0
Milano
Country [60] 0 0
Italy
State/province [60] 0 0
Pavia
Country [61] 0 0
Italy
State/province [61] 0 0
Terni
Country [62] 0 0
Netherlands
State/province [62] 0 0
Alkmaar
Country [63] 0 0
Netherlands
State/province [63] 0 0
Amsterdam
Country [64] 0 0
Netherlands
State/province [64] 0 0
Groningen
Country [65] 0 0
Netherlands
State/province [65] 0 0
Leeuwarden
Country [66] 0 0
Netherlands
State/province [66] 0 0
Nieuwegein
Country [67] 0 0
Netherlands
State/province [67] 0 0
Nijmegen
Country [68] 0 0
Netherlands
State/province [68] 0 0
Rotterdam
Country [69] 0 0
Netherlands
State/province [69] 0 0
Tilburg
Country [70] 0 0
Poland
State/province [70] 0 0
Chrzanow
Country [71] 0 0
Poland
State/province [71] 0 0
Dabrowa Gornicza
Country [72] 0 0
Poland
State/province [72] 0 0
Kedzierzyn-Kozle
Country [73] 0 0
Poland
State/province [73] 0 0
Krakov
Country [74] 0 0
Poland
State/province [74] 0 0
Mielec
Country [75] 0 0
Poland
State/province [75] 0 0
Nysa
Country [76] 0 0
Poland
State/province [76] 0 0
Ustron
Country [77] 0 0
Portugal
State/province [77] 0 0
Gaia
Country [78] 0 0
Portugal
State/province [78] 0 0
Lisbon
Country [79] 0 0
Singapore
State/province [79] 0 0
Singapore
Country [80] 0 0
Spain
State/province [80] 0 0
Barcelona
Country [81] 0 0
Spain
State/province [81] 0 0
Huelva
Country [82] 0 0
Spain
State/province [82] 0 0
Madrid
Country [83] 0 0
Spain
State/province [83] 0 0
Vigo
Country [84] 0 0
Switzerland
State/province [84] 0 0
Bern
Country [85] 0 0
Switzerland
State/province [85] 0 0
Geneva
Country [86] 0 0
Switzerland
State/province [86] 0 0
Lausanne
Country [87] 0 0
Switzerland
State/province [87] 0 0
Liestal
Country [88] 0 0
Switzerland
State/province [88] 0 0
Lugano
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Belfast
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Blackburn
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Blackpool
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Bournemouth
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Brighton
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Cambridge
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Cardiff
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Glasgow
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Leicester
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Liverpool
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Manchester
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Newcastle
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Rhyl
Country [102] 0 0
United Kingdom
State/province [102] 0 0
Southampton
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Stevenage
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ECRI bv
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Biosensors International
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
AstraZeneca
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/industry
Name [3] 0 0
The Medicines Company
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
After a stent procedure, it is common practice to prescribe anti-platelet medication to prevent the blood from clotting. The main objective of this study is to determine if there is a better medication strategy to prevent blood from clotting and at the same time minimising the number of complications.

There are two medication strategies:

* Study group: Dual anti-platelet therapy (ticagrelor combined with aspirin) for 1 month, and then ticagrelor alone for another 23 months OR
* Control group: Standard treatment, being dual anti-platelet therapy (ticagrelor or clopidogrel combined with aspirin) for 12 months, and then aspirin alone indefinitely
Trial website
https://clinicaltrials.gov/study/NCT01813435
Trial related presentations / publications
Vranckx P, Valgimigli M, Juni P, Hamm C, Steg PG, Heg D, van Es GA, McFadden EP, Onuma Y, van Meijeren C, Chichareon P, Benit E, Mollmann H, Janssens L, Ferrario M, Moschovitis A, Zurakowski A, Dominici M, Van Geuns RJ, Huber K, Slagboom T, Serruys PW, Windecker S; GLOBAL LEADERS Investigators. Ticagrelor plus aspirin for 1 month, followed by ticagrelor monotherapy for 23 months vs aspirin plus clopidogrel or ticagrelor for 12 months, followed by aspirin monotherapy for 12 months after implantation of a drug-eluting stent: a multicentre, open-label, randomised superiority trial. Lancet. 2018 Sep 15;392(10151):940-949. doi: 10.1016/S0140-6736(18)31858-0. Epub 2018 Aug 27.
Ono M, Hara H, Kawashima H, Gao C, Wang R, Wykrzykowska JJ, Piek JJ, Garg S, Hamm C, Steg PG, Valgimigli M, Windecker S, Vranckx P, Onuma Y, Serruys PW. Ticagrelor monotherapy versus aspirin monotherapy at 12 months after percutaneous coronary intervention: a landmark analysis of the GLOBAL LEADERS trial. EuroIntervention. 2022 Aug 5;18(5):e377-e388. doi: 10.4244/EIJ-D-21-00870.
Gragnano F, Zwahlen M, Vranckx P, Heg D, Schmidlin K, Hamm C, Steg PG, Gargiulo G, McFadden EP, Onuma Y, Chichareon P, Benit E, Mollmann H, Janssens L, Leonardi S, Zurakowski A, Arrivi A, Van Geuns RJ, Huber K, Slagboom T, Calabro P, Serruys PW, Juni P, Valgimigli M, Windecker S; GLOBAL LEADERS Investigators [Link]. Ticagrelor Monotherapy or Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation: Per-Protocol Analysis of the GLOBAL LEADERS Trial. J Am Heart Assoc. 2022 May 17;11(10):e024291. doi: 10.1161/JAHA.121.024291. Epub 2022 Mar 1.
Westra J, Eftekhari A, Renkens M, Mejia-Renteria H, Sejr-Hansen M, Stegehuis V, Holm NR, de Winter RJ, Piek JJ, Escaned J, Wykrzykowska JJ, Christiansen EH. Characterization of quantitative flow ratio and fractional flow reserve discordance using doppler flow and clinical follow-up. Int J Cardiovasc Imaging. 2022 Jun;38(6):1181-1190. doi: 10.1007/s10554-022-02522-1. Epub 2022 Jan 18.
Vranckx P, Valgimigli M, Odutayo A, Serruys PW, Hamm C, Steg PG, Heg D, Mc Fadden EP, Onuma Y, Benit E, Janssens L, Diletti R, Ferrario M, Huber K, Raber L, Windecker S, Juni P; GLOBAL LEADERS Investigators. Efficacy and Safety of Ticagrelor Monotherapy by Clinical Presentation: Pre-Specified Analysis of the GLOBAL LEADERS Trial. J Am Heart Assoc. 2021 Sep 21;10(18):e015560. doi: 10.1161/JAHA.119.015560. Epub 2021 Sep 17.
Gao C, Tomaniak M, Takahashi K, Kawashima H, Wang R, Hara H, Ono M, Montalescot G, Garg S, Haude M, Slagboom T, Vranckx P, Valgimigli M, Windecker S, van Geuns RJ, Hamm C, Steg PG, Onuma Y, Angiolillo DJ, Serruys PW. Ticagrelor monotherapy in patients with concomitant diabetes mellitus and chronic kidney disease: a post hoc analysis of the GLOBAL LEADERS trial. Cardiovasc Diabetol. 2020 Oct 16;19(1):179. doi: 10.1186/s12933-020-01153-x.
Kawashima H, Tomaniak M, Ono M, Wang R, Hara H, Gao C, Takahashi K, Sharif F, Thury A, Suryapranata H, Walsh S, Cotton J, Carrie D, Sabate M, Steinwender C, Leibundgut G, Wykrzykowska J, de Winter RJ, Garg S, Hamm C, Steg PG, Juni P, Vranckx P, Valgimigli M, Windecker S, Onuma Y, Serruys PW. Safety and Efficacy of 1-Month Dual Antiplatelet Therapy (Ticagrelor + Aspirin) Followed by 23-Month Ticagrelor Monotherapy in Patients Undergoing Staged Percutaneous Coronary Intervention (A Sub-Study from GLOBAL LEADERS). Am J Cardiol. 2021 Jan 1;138:1-10. doi: 10.1016/j.amjcard.2020.09.057. Epub 2020 Oct 13.
Gao C, Takahashi K, Garg S, Hara H, Wang R, Kawashima H, Ono M, Montalescot G, Haude M, Slagboom T, Vranckx P, Valgimigli M, Windecker S, Hamm C, Steg PG, Storey R, van Geuns RJ, Tao L, Onuma Y, Serruys PW. Regional variation in patients and outcomes in the GLOBAL LEADERS trial. Int J Cardiol. 2021 Feb 1;324:30-37. doi: 10.1016/j.ijcard.2020.09.039. Epub 2020 Sep 15.
Hara H, Takahashi K, Kogame N, Tomaniak M, Kerkmeijer LSM, Ono M, Kawashima H, Wang R, Gao C, Wykrzykowska JJ, de Winter RJ, Neumann FJ, Plante S, Lemos Neto PA, Garg S, Juni P, Vranckx P, Windecker S, Valgimigli M, Hamm C, Steg PG, Onuma Y, Serruys PW. Impact of Bleeding and Myocardial Infarction on Mortality in All-Comer Patients Undergoing Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2020 Sep;13(9):e009177. doi: 10.1161/CIRCINTERVENTIONS.120.009177. Epub 2020 Aug 25.
Hara H, van Klaveren D, Takahashi K, Kogame N, Chichareon P, Modolo R, Tomaniak M, Ono M, Kawashima H, Wang R, Gao C, Niethammer M, Fontos G, Angioi M, Ribeiro VG, Barbato E, Leandro S, Hamm C, Valgimigli M, Windecker S, Juni P, Steg PG, Verbeeck J, Tijssen JGP, Sharif F, Onuma Y, Serruys PW; GLOBAL LEADERS Trial Investigators. Comparative Methodological Assessment of the Randomized GLOBAL LEADERS Trial Using Total Ischemic and Bleeding Events. Circ Cardiovasc Qual Outcomes. 2020 Aug;13(8):e006660. doi: 10.1161/CIRCOUTCOMES.120.006660. Epub 2020 Jul 30.
Ono M, Chichareon P, Tomaniak M, Kawashima H, Takahashi K, Kogame N, Modolo R, Hara H, Gao C, Wang R, Walsh S, Suryapranata H, da Silva PC, Cotton J, Koning R, Akin I, Rensing BJWM, Garg S, Wykrzykowska JJ, Piek JJ, Juni P, Hamm C, Steg PG, Valgimigli M, Windecker S, Storey RF, Onuma Y, Vranckx P, Serruys PW. The association of body mass index with long-term clinical outcomes after ticagrelor monotherapy following abbreviated dual antiplatelet therapy in patients undergoing percutaneous coronary intervention: a prespecified sub-analysis of the GLOBAL LEADERS Trial. Clin Res Cardiol. 2020 Sep;109(9):1125-1139. doi: 10.1007/s00392-020-01604-1. Epub 2020 Jan 31.
Tomaniak M, Chichareon P, Klimczak-Tomaniak D, Takahashi K, Kogame N, Modolo R, Wang R, Ono M, Hara H, Gao C, Kawashima H, Rademaker-Havinga T, Garg S, Curzen N, Haude M, Kochman J, Gori T, Montalescot G, Angiolillo DJ, Capodanno D, Storey RF, Hamm C, Vranckx P, Valgimigli M, Windecker S, Onuma Y, Serruys PW, Anderson R. Impact of renal function on clinical outcomes after PCI in ACS and stable CAD patients treated with ticagrelor: a prespecified analysis of the GLOBAL LEADERS randomized clinical trial. Clin Res Cardiol. 2020 Jul;109(7):930-943. doi: 10.1007/s00392-019-01586-9. Epub 2020 Jan 10.
Tomaniak M, Chichareon P, Takahashi K, Kogame N, Modolo R, Chang CC, Spitzer E, Neumann FJ, Plante S, Hernandez Antolin R, Jambrik Z, Gelev V, Brunel P, Konteva M, Beygui F, Morelle JF, Filipiak KJ, van Geuns RJ, Soliman O, Tijssen J, Rademaker-Havinga T, Storey RF, Hamm C, Steg PG, Windecker S, Onuma Y, Valgimigli M, Serruys PW; GLOBAL LEADERS Study Investigators. Impact of chronic obstructive pulmonary disease and dyspnoea on clinical outcomes in ticagrelor treated patients undergoing percutaneous coronary intervention in the randomized GLOBAL LEADERS trial. Eur Heart J Cardiovasc Pharmacother. 2020 Jul 1;6(4):222-230. doi: 10.1093/ehjcvp/pvz052.
Tomaniak M, Chichareon P, Modolo R, Takahashi K, Chang CC, Kogame N, Spitzer E, Buszman PE, van Geuns RM, Valkov V, Steinwender C, Geisler T, Prokopczuk J, Sabate M, Zmudka K, Rademaker-Havinga T, Tijssen JGP, Juni P, Hamm C, Steg PG, Onuma Y, Vranckx P, Valgimigli M, Windecker S, Baber U, Anderson R, Dominici M, Serruys PW. Ticagrelor monotherapy beyond one month after PCI in ACS or stable CAD in elderly patients: a pre-specified analysis of the GLOBAL LEADERS trial. EuroIntervention. 2020 Apr 3;15(18):e1605-e1614. doi: 10.4244/EIJ-D-19-00699.
Chichareon P, Modolo R, Kerkmeijer L, Tomaniak M, Kogame N, Takahashi K, Chang CC, Komiyama H, Moccetti T, Talwar S, Colombo A, Maillard L, Barlis P, Wykrzykowska J, Piek JJ, Garg S, Hamm C, Steg PG, Juni P, Valgimigli M, Windecker S, Onuma Y, Mehran R, Serruys PW. Association of Sex With Outcomes in Patients Undergoing Percutaneous Coronary Intervention: A Subgroup Analysis of the GLOBAL LEADERS Randomized Clinical Trial. JAMA Cardiol. 2020 Jan 1;5(1):21-29. doi: 10.1001/jamacardio.2019.4296.
Takahashi K, Serruys PW, Chichareon P, Chang CC, Tomaniak M, Modolo R, Kogame N, Magro M, Chowdhary S, Eitel I, Zweiker R, Ong P, Ottesen MM, Tijssen JGP, Wykrzykowska JJ, de Winter RJ, Garg S, Stoll HP, Hamm C, Steg PG, Onuma Y, Valgimigli M, Vranckx P, Carrie D, Windecker S. Efficacy and Safety of Ticagrelor Monotherapy in Patients Undergoing Multivessel PCI. J Am Coll Cardiol. 2019 Oct 22;74(16):2015-2027. doi: 10.1016/j.jacc.2019.08.997.
Tomaniak M, Chichareon P, Onuma Y, Deliargyris EN, Takahashi K, Kogame N, Modolo R, Chang CC, Rademaker-Havinga T, Storey RF, Dangas GD, Bhatt DL, Angiolillo DJ, Hamm C, Valgimigli M, Windecker S, Steg PG, Vranckx P, Serruys PW; GLOBAL LEADERS Trial Investigators. Benefit and Risks of Aspirin in Addition to Ticagrelor in Acute Coronary Syndromes: A Post Hoc Analysis of the Randomized GLOBAL LEADERS Trial. JAMA Cardiol. 2019 Nov 1;4(11):1092-1101. doi: 10.1001/jamacardio.2019.3355.
Serruys PW, Tomaniak M, Chichareon P, Modolo R, Kogame N, Takahashi K, Chang CC, Spitzer E, Walsh SJ, Adlam D, Hildick-Smith D, Edes I, van de Harst P, Krackhardt F, Tijssen JGP, Rademaker-Havinga T, Garg S, Steg PG, Hamm C, Juni P, Vranckx P, Onuma Y, Verheugt FWA. Patient-oriented composite endpoints and net adverse clinical events with ticagrelor monotherapy following percutaneous coronary intervention: insights from the randomised GLOBAL LEADERS trial. EuroIntervention. 2019 Dec 20;15(12):e1090-e1098. doi: 10.4244/EIJ-D-19-00202.
Leonardi S, Franzone A, Piccolo R, McFadden E, Vranckx P, Serruys P, Benit E, Liebetrau C, Janssens L, Ferrario M, Zurakowski A, van Geuns RJ, Dominici M, Huber K, Slagboom T, Buszman P, Bolognese L, Tumscitz C, Bryniarski K, Aminian A, Vrolix M, Petrov I, Garg S, Naber C, Prokopczuk J, Hamm C, Steg G, Heg D, Juni P, Windecker S, Valgimigli M. Rationale and design of a prospective substudy of clinical endpoint adjudication processes within an investigator-reported randomised controlled trial in patients with coronary artery disease: the GLOBAL LEADERS Adjudication Sub-StudY (GLASSY). BMJ Open. 2019 Mar 9;9(3):e026053. doi: 10.1136/bmjopen-2018-026053.
Public notes

Contacts
Principal investigator
Name 0 0
Ernest Spitzer, MD
Address 0 0
European Cardiovascular Research Institute
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/NCT01813435