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)
NCT ID: NCT01347580
Last Updated: 2015-07-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1875 participants
INTERVENTIONAL
2011-09-30
2013-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
Ticagrelor
Oral Ticagrelor loading dose (180 mg) followed by matching placebo
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.
Placebo
Placebo followed by oral Ticagrelor loading dose (180 mg)
Interventions
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Ticagrelor
Oral Ticagrelor loading dose (180 mg) followed by matching placebo
Placebo
Placebo followed by oral Ticagrelor loading dose (180 mg)
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Dr Judith Hsia, MD
Role: STUDY_DIRECTOR
AstraZeneca
Pr Gilles Montalescot
Role: PRINCIPAL_INVESTIGATOR
Pitie Salpetriere Hospital
Locations
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Research Site
Algiers, , Algeria
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Blida, , Algeria
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Herston, , Australia
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Southport, , Australia
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Woolloongabba, , Australia
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Graz, , Austria
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Innsbruck, , Austria
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Vienna, , Austria
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Halifax, Nova Scotia, Canada
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Newmarket, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Regina, Saskatchewan, Canada
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Aalborg, , Denmark
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Aarhus, , Denmark
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Odense C, , Denmark
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Aubervilliers, , France
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Besançon, , France
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Boulogne-Billancourt, , France
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Bourges, , France
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Bron, , France
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Châteauroux, , France
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Corbeil-Essonnes, , France
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Créteil, , France
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Dijon, , France
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Lagny-sur-Marne, , France
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Le Chesnay, , France
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Le Coudray, , France
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Lyon, , France
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Marseille, , France
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Massy, , France
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Melun, , France
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Montauban, , France
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Montfermeil, , France
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Montreuil, , France
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Neuilly-sur-Seine, , France
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Nîmes, , France
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Paris, , France
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Pessac, , France
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Quincy-sous-Sénart, , France
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Rouen, , France
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Strasbourg, , France
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Tours, , France
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Vannes, , France
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Bad Friedrichshall, , Germany
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Bad Nauheim, , Germany
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Darmstadt, , Germany
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Esslingen am Neckar, , Germany
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Freiburg im Breisgau, , Germany
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Giessen, , Germany
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Hanover, , Germany
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Ludwigshafen, , Germany
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Lüdenscheid, , Germany
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Mainz, , Germany
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Merseburg, , Germany
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Wuppertal, , Germany
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Budapest, , Hungary
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Debrecen, , Hungary
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Pécs, , Hungary
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Szeged, , Hungary
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Arezzo, , Italy
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Ascoli Piceno, , Italy
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Cona, , Italy
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Forlì, , Italy
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Genova, , Italy
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Grosseto, , Italy
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Massa, , Italy
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Seriate, , Italy
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Siena, , Italy
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's-Hertogenbosch, , Netherlands
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Alkmaar, , Netherlands
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Arnhem, , Netherlands
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Terneuzen, , Netherlands
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A Coruña, , Spain
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Alicante, , Spain
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Badalona, , Spain
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Barcelona, , Spain
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Hospitalet de Llobregat(Barcel, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Santiago(A Coruña), , Spain
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Seville, , Spain
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Vigo(Pontevedra), , Spain
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Gävle, , Sweden
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Linköping, , Sweden
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Örebro, , Sweden
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Uppsala, , Sweden
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Ashford, , United Kingdom
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Belfast, , United Kingdom
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Cambridge, , United Kingdom
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Coventry, , United Kingdom
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Eastbourne, , United Kingdom
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Hastings, , United Kingdom
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Middlesbrough, , United Kingdom
Research Site
Newcastle upon Tyne, , United Kingdom
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Norwich, , United Kingdom
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Sheffield, , United Kingdom
Countries
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References
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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.
Related Links
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Other Identifiers
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D5130L00006
Identifier Type: -
Identifier Source: org_study_id
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