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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01347580




Registration number
NCT01347580
Ethics application status
Date submitted
19/04/2011
Date registered
4/05/2011
Date last updated
22/07/2015

Titles & IDs
Public title
A 30 Day Study to Evaluate Efficacy and Safety of Pre-hospital vs. In-hospital Initiation of Ticagrelor Therapy in STEMI Patients Planned for Percutaneous Coronary Intervention (PCI)
Scientific title
A 30 Day International, Randomized, Parallel-group, Double-blind, Placebo-controlled Phase IV Study to Evaluate Efficacy and Safety of Pre-hospital vs. In-hospital Initiation of Ticagrelor Therapy in STEMI Patients Planned for PCI.
Secondary ID [1] 0 0
D5130L00006
Universal Trial Number (UTN)
Trial acronym
ATLANTIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial Infarction 0 0
Segment Elevation Myocardial Infarction (STEMI) 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

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

Experimental: Ticagrelor - Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.

Experimental: Placebo - Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.


Treatment: Drugs: Ticagrelor
Oral Ticagrelor loading dose (180 mg) followed by matching placebo

Treatment: Drugs: Placebo
Placebo followed by oral Ticagrelor loading dose (180 mg)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 of MI Culprit Vessel at Initial Angiography (Co-primary Endpoint)
Timepoint [1] 0 0
At initial angiography, pre PCI
Primary outcome [2] 0 0
ST-segment Elevation Resolution Pre PCI =70% (Co-primary Endpoint)
Timepoint [2] 0 0
Between baseline and PCI
Secondary outcome [1] 0 0
1st Composite Clinical Endpoint
Timepoint [1] 0 0
during the 30 days of treatment
Secondary outcome [2] 0 0
2nd Composite Clinical Endpoint
Timepoint [2] 0 0
within 30 days of study
Secondary outcome [3] 0 0
Definite Stent Thrombosis
Timepoint [3] 0 0
during 30 days of treatment
Secondary outcome [4] 0 0
TIMI Flow Grade 3 Post -PCI
Timepoint [4] 0 0
at coroangiography post-PCI
Secondary outcome [5] 0 0
ST Segment Elevation Resolution Post-PCI >= 70%
Timepoint [5] 0 0
Between baseline and ECG 60 mn post-PCI
Secondary outcome [6] 0 0
Thrombotic Bail-out With GPIIb/IIIa Inhibitors at Initial PCI
Timepoint [6] 0 0
during PCI
Secondary outcome [7] 0 0
Major Bleeds Within 48 Hours
Timepoint [7] 0 0
within 48 hours of first dose
Secondary outcome [8] 0 0
Minor and Major Bleedings Within 48 Hours
Timepoint [8] 0 0
within 48 hours of first dose
Secondary outcome [9] 0 0
Major Bleeds After 48 Hours
Timepoint [9] 0 0
after 48hours post-first dose
Secondary outcome [10] 0 0
Minor and Major Bleeds After 48 Hours
Timepoint [10] 0 0
after 48 hours post first dose

Eligibility
Key inclusion criteria
* Women must not be of child-bearing potential (1 year post-menopausal or surgically sterile).
* Symptoms of acute MI of more than 30 min but less than 6 hours
* New persistent ST-segment elevation = 1 mm in two or more contiguous electrocardiogram (ECG) leads.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Expected time to 1st PCI balloon inflation in the hospital, from the qualifying ECG is more than 120 minutes
* Contraindication to ticagrelor (refer to SmPC)
* Concomitant medication that may increase the risk of bleeding [e.g non steroidal anti-inflammatory drugs (NSAIDs), oral anticoagulant and / or fibrinolytics, planned or administered 24 hours before randomization]
* Any of the following conditions in the absence of a functioning implanted pacemaker: known SSS, second or third degree AVB, or documented syncope of suspected bradycardic origin.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
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
1/09/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2013
Sample size
Target
Accrual to date
Final
1875
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Herston
Recruitment hospital [2] 0 0
Research Site - Southport
Recruitment hospital [3] 0 0
Research Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
- Herston
Recruitment postcode(s) [2] 0 0
- Southport
Recruitment postcode(s) [3] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
Algeria
State/province [1] 0 0
Algiers
Country [2] 0 0
Algeria
State/province [2] 0 0
Blida
Country [3] 0 0
Austria
State/province [3] 0 0
Graz
Country [4] 0 0
Austria
State/province [4] 0 0
Innsbruck
Country [5] 0 0
Austria
State/province [5] 0 0
Wien
Country [6] 0 0
Canada
State/province [6] 0 0
Nova Scotia
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Canada
State/province [8] 0 0
Saskatchewan
Country [9] 0 0
Denmark
State/province [9] 0 0
Aalborg
Country [10] 0 0
Denmark
State/province [10] 0 0
Odense C
Country [11] 0 0
Denmark
State/province [11] 0 0
Århus
Country [12] 0 0
France
State/province [12] 0 0
Aubervilliers
Country [13] 0 0
France
State/province [13] 0 0
Besançon
Country [14] 0 0
France
State/province [14] 0 0
Boulogne Billancourt
Country [15] 0 0
France
State/province [15] 0 0
Bourges
Country [16] 0 0
France
State/province [16] 0 0
Bron
Country [17] 0 0
France
State/province [17] 0 0
Chateauroux
Country [18] 0 0
France
State/province [18] 0 0
Corbeil Essonnes Cedex
Country [19] 0 0
France
State/province [19] 0 0
Creteil
Country [20] 0 0
France
State/province [20] 0 0
Dijon
Country [21] 0 0
France
State/province [21] 0 0
LAGNY SUR MARNE cedex
Country [22] 0 0
France
State/province [22] 0 0
Le Chesnay
Country [23] 0 0
France
State/province [23] 0 0
Le Coudray
Country [24] 0 0
France
State/province [24] 0 0
Lyon Cedex 04
Country [25] 0 0
France
State/province [25] 0 0
Lyon
Country [26] 0 0
France
State/province [26] 0 0
MARSEILLE cedex 15
Country [27] 0 0
France
State/province [27] 0 0
Marseille
Country [28] 0 0
France
State/province [28] 0 0
Massy
Country [29] 0 0
France
State/province [29] 0 0
Melun
Country [30] 0 0
France
State/province [30] 0 0
Montauban
Country [31] 0 0
France
State/province [31] 0 0
Montfermeil
Country [32] 0 0
France
State/province [32] 0 0
MONTREUIL Cedex
Country [33] 0 0
France
State/province [33] 0 0
Neuilly Sur Seine
Country [34] 0 0
France
State/province [34] 0 0
Nimes
Country [35] 0 0
France
State/province [35] 0 0
Paris Cedex 13
Country [36] 0 0
France
State/province [36] 0 0
PARIS Cedex 15
Country [37] 0 0
France
State/province [37] 0 0
Paris
Country [38] 0 0
France
State/province [38] 0 0
PESSAC Cedex
Country [39] 0 0
France
State/province [39] 0 0
Quincy sous Sénart
Country [40] 0 0
France
State/province [40] 0 0
Rouen Cedex
Country [41] 0 0
France
State/province [41] 0 0
Strasbourg
Country [42] 0 0
France
State/province [42] 0 0
TOURS Cedex 9
Country [43] 0 0
France
State/province [43] 0 0
TOURS cedex
Country [44] 0 0
France
State/province [44] 0 0
VANNES cedex
Country [45] 0 0
Germany
State/province [45] 0 0
Bad Friedrichshall
Country [46] 0 0
Germany
State/province [46] 0 0
Bad Nauheim
Country [47] 0 0
Germany
State/province [47] 0 0
Darmstadt
Country [48] 0 0
Germany
State/province [48] 0 0
Esslingen
Country [49] 0 0
Germany
State/province [49] 0 0
Freiburg
Country [50] 0 0
Germany
State/province [50] 0 0
Gießen
Country [51] 0 0
Germany
State/province [51] 0 0
Hannover
Country [52] 0 0
Germany
State/province [52] 0 0
Ludwigshafen
Country [53] 0 0
Germany
State/province [53] 0 0
Lüdenscheid
Country [54] 0 0
Germany
State/province [54] 0 0
Mainz
Country [55] 0 0
Germany
State/province [55] 0 0
Merseburg
Country [56] 0 0
Germany
State/province [56] 0 0
Wuppertal
Country [57] 0 0
Hungary
State/province [57] 0 0
Budapest
Country [58] 0 0
Hungary
State/province [58] 0 0
Debrecen
Country [59] 0 0
Hungary
State/province [59] 0 0
Pécs
Country [60] 0 0
Hungary
State/province [60] 0 0
Szeged
Country [61] 0 0
Italy
State/province [61] 0 0
Arezzo
Country [62] 0 0
Italy
State/province [62] 0 0
Ascoli Piceno
Country [63] 0 0
Italy
State/province [63] 0 0
Cona
Country [64] 0 0
Italy
State/province [64] 0 0
Forlì
Country [65] 0 0
Italy
State/province [65] 0 0
Genova
Country [66] 0 0
Italy
State/province [66] 0 0
Grosseto
Country [67] 0 0
Italy
State/province [67] 0 0
Massa
Country [68] 0 0
Italy
State/province [68] 0 0
Seriate
Country [69] 0 0
Italy
State/province [69] 0 0
Siena
Country [70] 0 0
Netherlands
State/province [70] 0 0
Alkmaar
Country [71] 0 0
Netherlands
State/province [71] 0 0
Arnhem
Country [72] 0 0
Netherlands
State/province [72] 0 0
Den Bosch
Country [73] 0 0
Netherlands
State/province [73] 0 0
Terneuzen
Country [74] 0 0
Spain
State/province [74] 0 0
A Coruña
Country [75] 0 0
Spain
State/province [75] 0 0
Alicante
Country [76] 0 0
Spain
State/province [76] 0 0
Badalona
Country [77] 0 0
Spain
State/province [77] 0 0
Barcelona
Country [78] 0 0
Spain
State/province [78] 0 0
Hospitalet de Llobregat(Barcel
Country [79] 0 0
Spain
State/province [79] 0 0
Madrid
Country [80] 0 0
Spain
State/province [80] 0 0
Málaga
Country [81] 0 0
Spain
State/province [81] 0 0
Santiago(A Coruña)
Country [82] 0 0
Spain
State/province [82] 0 0
Sevilla
Country [83] 0 0
Spain
State/province [83] 0 0
Vigo(Pontevedra)
Country [84] 0 0
Sweden
State/province [84] 0 0
Gävle
Country [85] 0 0
Sweden
State/province [85] 0 0
Linköping
Country [86] 0 0
Sweden
State/province [86] 0 0
Uppsala
Country [87] 0 0
Sweden
State/province [87] 0 0
Örebro
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Ashford
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Belfast
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Cambridge
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Coventry
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Eastbourne
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Hastings
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Middlesborough
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Newcastle-Upon-Tyne
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Norwich
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The aim of this study is to determine whether initiation of ticagrelor as early as in the ambulance setting leads to a rapid reperfusion of the infarct-related artery therefore facilitating the Percutaneous Coronary Intervention (PCI) and optimizing the outcome for the patient.

The study will assess the efficacy and safety of pre-hospital compared to in-hospital administration of ticagrelor in co-administration with aspirin, on restoring the blood flow in the occluded heart artery and improving the myocardial perfusion in patients suffering from myocardial infarction and planned to have a PCI. Patients can be randomised in either one of the 2 arms:

re-hospital ticagrelor arm: Patients will receive a loading dose of 180 mg ticagrelor for the pre-hospital administration and placebo for in-hospital administration.

or In-hospital ticagrelor arm: Patients will receive a placebo for pre-hospital administration and 180 mg ticagrelor loading dose for in-hospital administration.

Patients are initially managed by ambulance physician/personnel in pre hospital settings. They are then transferred into a Catheterization room to undergo a PCI.

After the administration of the loading dose of ticagrelor (double blind), patients will continue on ticagrelor 90 mg bid and be followed in study for 30 days post randomisation.
Trial website
https://clinicaltrials.gov/study/NCT01347580
Trial related presentations / publications
Montalescot G, van 't Hof AW, Lapostolle F, Silvain J, Lassen JF, Bolognese L, Cantor WJ, Cequier A, Chettibi M, Goodman SG, Hammett CJ, Huber K, Janzon M, Merkely B, Storey RF, Zeymer U, Stibbe O, Ecollan P, Heutz WM, Swahn E, Collet JP, Willems FF, Baradat C, Licour M, Tsatsaris A, Vicaut E, Hamm CW; ATLANTIC Investigators. Prehospital ticagrelor in ST-segment elevation myocardial infarction. N Engl J Med. 2014 Sep 11;371(11):1016-27. doi: 10.1056/NEJMoa1407024. Epub 2014 Sep 1.
Lapostolle F, Van't Hof AW, Hamm CW, Stibbe O, Ecollan P, Collet JP, Silvain J, Lassen JF, Heutz WMJM, Bolognese L, Cantor WJ, Cequier A, Chettibi M, Goodman SG, Hammett CJ, Huber K, Janzon M, Merkely B, Storey RF, Ten Berg J, Zeymer U, Licour M, Tsatsaris A, Montalescot G; ATLANTIC Investigators. Morphine and Ticagrelor Interaction in Primary Percutaneous Coronary Intervention in ST-Segment Elevation Myocardial Infarction: ATLANTIC-Morphine. Am J Cardiovasc Drugs. 2019 Apr;19(2):173-183. doi: 10.1007/s40256-018-0305-0.
Fabris E, Van't Hof A, Hamm CW, Lapostolle F, Lassen JF, Goodman SG, Ten Berg JM, Bolognese L, Cequier A, Chettibi M, Hammett CJ, Huber K, Janzon M, Merkely B, Storey RF, Zeymer U, Cantor WJ, Kerneis M, Diallo A, Vicaut E, Montalescot G; ATLANTIC investigators. Pre-hospital administration of ticagrelor in diabetic patients with ST-elevation myocardial infarction undergoing primary angioplasty: A sub-analysis of the ATLANTIC trial. Catheter Cardiovasc Interv. 2019 Jun 1;93(7):E369-E377. doi: 10.1002/ccd.27921. Epub 2018 Oct 9.
Bagai A, Goodman SG, Cantor WJ, Vicaut E, Bolognese L, Cequier A, Chettibi M, Hammett CJ, Huber K, Janzon M, Lapostolle F, Lassen JF, Merkely B, Storey RF, Ten Berg JM, Zeymer U, Diallo A, Hamm CW, Tsatsaris A, El Khoury J, Van't Hof AW, Montalescot G. Duration of ischemia and treatment effects of pre- versus in-hospital ticagrelor in patients with ST-segment elevation myocardial infarction: Insights from the ATLANTIC study. Am Heart J. 2018 Feb;196:56-64. doi: 10.1016/j.ahj.2017.10.021. Epub 2017 Nov 4.
Kilic S, Fabris E, Van't Hof AWJ, Hamm CW, Lapostolle F, Lassen JF, Tsatsaris A, Diallo A, Vicaut E, Montalescot G; ATLANTIC Investigators. Thrombus aspiration and prehospital ticagrelor administration in ST-elevation myocardial infarction: Findings from the ATLANTIC trial. Am Heart J. 2018 Feb;196:1-8. doi: 10.1016/j.ahj.2017.09.018. Epub 2017 Oct 3.
Venetsanos D, Sederholm Lawesson S, Alfredsson J, Janzon M, Cequier A, Chettibi M, Goodman SG, Van't Hof AW, Montalescot G, Swahn E. Association between gender and short-term outcome in patients with ST elevation myocardial infraction participating in the international, prospective, randomised Administration of Ticagrelor in the catheterisation Laboratory or in the Ambulance for New ST elevation myocardial Infarction to open the Coronary artery (ATLANTIC) trial: a prespecified analysis. BMJ Open. 2017 Sep 21;7(9):e015241. doi: 10.1136/bmjopen-2016-015241.
Cayla G, Lapostolle F, Ecollan P, Stibbe O, Benezet JF, Henry P, Hammett CJ, Lassen JF, Storey RF, Ten Berg JM, Hamm CW, Van't Hof AW, Montalescot G; ACTION study group. Pre-hospital ticagrelor in ST-segment elevation myocardial infarction in the French ATLANTIC population. Int J Cardiol. 2017 Oct 1;244:49-53. doi: 10.1016/j.ijcard.2017.06.009. Epub 2017 Jun 9.
Lupi A, Schaffer A, Lazzero M, Tessitori M, De Martino L, Rognoni A, Bongo AS, Porto I. Pre-hospital ticagrelor in patients with ST-segment elevation myocardial infarction with long transport time to primary PCI facility. Cardiovasc Revasc Med. 2016 Dec;17(8):528-534. doi: 10.1016/j.carrev.2016.08.005. Epub 2016 Aug 20.
Silvain J, Storey RF, Cayla G, Esteve JB, Dillinger JG, Rousseau H, Tsatsaris A, Baradat C, Salhi N, Hamm CW, Lapostolle F, Lassen JF, Collet JP, Ten Berg JM, Van't Hof AW, Montalescot G. P2Y12 receptor inhibition and effect of morphine in patients undergoing primary PCI for ST-segment elevation myocardial infarction. The PRIVATE-ATLANTIC study. Thromb Haemost. 2016 Aug 1;116(2):369-78. doi: 10.1160/TH15-12-0944. Epub 2015 May 19.
Montalescot G, van 't Hof AW, Bolognese L, Cantor WJ, Cequier A, Chettibi M, Collet JP, Goodman SG, Hammett CJ, Huber K, Janzon M, Lapostolle F, Lassen JF, Licour M, Merkely B, Salhi N, Silvain J, Storey RF, Ten Berg JM, Tsatsaris A, Zeymer U, Vicaut E, Hamm CW; ATLANTIC Investigators. Effect of Pre-Hospital Ticagrelor During the First 24 h After Primary Percutaneous Coronary Intervention in Patients With ST-Segment Elevation Myocardial Infarction: The ATLANTIC-H(2)(4) Analysis. JACC Cardiovasc Interv. 2016 Apr 11;9(7):646-56. doi: 10.1016/j.jcin.2015.12.024. Epub 2016 Mar 5.
Montalescot G, Lassen JF, Hamm CW, Lapostolle F, Silvain J, ten Berg JM, Cantor WJ, Goodman SG, Licour M, Tsatsaris A, van't Hof AW. Ambulance or in-catheterization laboratory administration of ticagrelor for primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: rationale and design of the randomized, double-blind Administration of Ticagrelor in the cath Lab or in the Ambulance for New ST elevation myocardial Infarction to open the Coronary artery (ATLANTIC) study. Am Heart J. 2013 Apr;165(4):515-22. doi: 10.1016/j.ahj.2012.12.015. Epub 2013 Feb 13.
Public notes

Contacts
Principal investigator
Name 0 0
Dr Judith Hsia, MD
Address 0 0
AstraZeneca
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/NCT01347580