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)
ATLANTIC
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.
1 other identifier
interventional
1,875
12 countries
93
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2011
Typical duration for phase_4
93 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2011
CompletedFirst Posted
Study publicly available on registry
May 4, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedResults Posted
Study results publicly available
February 11, 2015
CompletedJuly 22, 2015
July 1, 2015
2.2 years
April 19, 2011
November 13, 2014
July 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 of MI Culprit Vessel at Initial Angiography (Co-primary Endpoint)
(TIMI) flow grade classification is used to assess coronary blood flow in acute coronary syndromes. grade 0:no reperfusion, grade 1: penetration without perfusion, grade 2: Partial reperfusion, grade 3: complete perfusion.
At initial angiography, pre PCI
ST-segment Elevation Resolution Pre PCI ≥70% (Co-primary Endpoint)
ST segment elevation resolution is the mean ST elevation pre-hospital minus the mean STelevation pre-PCI divided by the mean ST elevation pre-hospital. It is expressed as a percentage and split in 2 categories , complete (≥70%) versus incomplete (\<70%) resolution.
Between baseline and PCI
Secondary Outcomes (10)
1st Composite Clinical Endpoint
during the 30 days of treatment
2nd Composite Clinical Endpoint
within 30 days of study
Definite Stent Thrombosis
during 30 days of treatment
TIMI Flow Grade 3 Post -PCI
at coroangiography post-PCI
ST Segment Elevation Resolution Post-PCI >= 70%
Between baseline and ECG 60 mn post-PCI
- +5 more secondary outcomes
Study Arms (2)
Ticagrelor
EXPERIMENTALLoading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
Placebo
EXPERIMENTALPlacebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (96)
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
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Newcastle upon Tyne, United Kingdom
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Norwich, United Kingdom
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Sheffield, United Kingdom
Related Publications (11)
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.
PMID: 25175921RESULTLapostolle 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.
PMID: 30353444DERIVEDFabris 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.
PMID: 30302940DERIVEDBagai 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.
PMID: 29421015DERIVEDKilic 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.
PMID: 29421001DERIVEDVenetsanos 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.
PMID: 28939567DERIVEDCayla 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.
PMID: 28622941DERIVEDLupi 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.
PMID: 27666002DERIVEDSilvain 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.
PMID: 27196998DERIVEDMontalescot 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.
PMID: 26952907DERIVEDMontalescot 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.
PMID: 23537967DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This urgent setting study included 8.6% of patients with symptoms of MI in ambulance but having finally not a STEMI diagnosis in cathlab. No prespecified hypothesis and procedure for adjustment was made on secondary endpoints.
Results Point of Contact
- Title
- Dr Tomas Andersson MD
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Dr Judith Hsia, MD
AstraZeneca
- PRINCIPAL INVESTIGATOR
Pr Gilles Montalescot
Pitie Salpetriere Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2011
First Posted
May 4, 2011
Study Start
September 1, 2011
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
July 22, 2015
Results First Posted
February 11, 2015
Record last verified: 2015-07