Myocardial InfarctionPhase 4ATLANTICNCT01347580
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)
A Phase 4 study testing Ticagrelor in people with Myocardial Infarction and Segment Elevation Myocardial Infarction (STEMI), run by AstraZeneca at 96 sites in 13 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Segment Elevation Myocardial Infarction (STEMI)
- What is being tested?
- Ticagrelor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,875 participants
- Where
- 96 sitesin 13 countries
- Study dates
- Sep 2011to Nov 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
96 sites in 13 countries.
96 sites in 13 countries
France28 sites
Research Site
Aubervilliers
Research Site
Besançon
Research Site
Boulogne-Billancourt
Research Site
Bourges
Research Site
Bron
Research Site
Châteauroux
Research Site
Corbeil-Essonnes
Research Site
Créteil
Research Site
Dijon
Research Site
Lagny-sur-Marne
Research Site
Le Chesnay
Research Site
Le Coudray
Research Site
Lyon
Research Site
Marseille
Research Site
Massy
Research Site
Melun
Research Site
Montauban
Research Site
Montfermeil
Research Site
Montreuil
Research Site
Neuilly-sur-Seine
Research Site
Nîmes
Research Site
Paris
Research Site
Pessac
Research Site
Quincy-sous-Sénart
Research Site
Rouen
Research Site
Strasbourg
Research Site
Tours
Research Site
Vannes
Germany12 sites
Research Site
Bad Friedrichshall
Research Site
Bad Nauheim
Research Site
Darmstadt
Research Site
Esslingen am Neckar
Research Site
Freiburg im Breisgau
Research Site
Giessen
Research Site
Hanover
Research Site
Lüdenscheid
Research Site
Ludwigshafen
Research Site
Mainz
Research Site
Merseburg
Research Site
Wuppertal
Spain10 sites
Research Site
A Coruña
Research Site
Alicante
Research Site
Badalona
Research Site
Barcelona
Research Site
Hospitalet de Llobregat(Barcel
Research Site
Madrid
Research Site
Málaga
Research Site
Santiago(A Coruña)
Research Site
Seville
Research Site
Vigo(Pontevedra)
United Kingdom10 sites
Research Site
Ashford
Research Site
Belfast
Research Site
Cambridge
Research Site
Coventry
Research Site
Eastbourne
Research Site
Hastings
Research Site
Middlesbrough
Research Site
Newcastle upon Tyne
Research Site
Norwich
Research Site
Sheffield
Italy9 sites
Research Site
Arezzo
Research Site
Ascoli Piceno
Research Site
Cona
Research Site
Forlì
Research Site
Genova
Research Site
Grosseto
Research Site
Massa
Research Site
Seriate
Research Site
Siena
Canada4 sites
Research Site
Halifax, Nova Scotia
Research Site
Newmarket, Ontario
Research Site
Regina, Saskatchewan
Research Site
Scarborough Village, Ontario
Hungary4 sites
Research Site
Budapest
Research Site
Debrecen
Research Site
Pécs
Research Site
Szeged
Netherlands4 sites
Research Site
's-Hertogenbosch
Research Site
Alkmaar
Research Site
Arnhem
Research Site
Terneuzen
Sweden4 sites
Research Site
Gävle
Research Site
Linköping
Research Site
Örebro
Research Site
Uppsala
Australia3 sites
Research Site
Herston
Research Site
Southport
Research Site
Woolloongabba
Denmark3 sites
Research Site
Aalborg
Research Site
Aarhus
Research Site
Odense C
About this study
Official 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.
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:
Read more
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.
- Being tested
- Ticagrelor, Placebo
- Keywords
- Heart attack, heart disease, cardiovascular disease, stroke, reperfusion, pre hospital settings, ticagrelor, Percutaneous Coronary Intervention
- Medical subject headings
- Myocardial Infarction, Heart Diseases, Cardiovascular Diseases, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
Oral Ticagrelor loading dose (180 mg) followed by matching placebo
PlaceboDrug
Placebo followed by oral Ticagrelor loading dose (180 mg)
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor | Experimental | 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. Receives: Drug: Ticagrelor |
| Placebo | Experimental | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Between baseline and PCI
Secondary outcomes (10)
1st Composite Clinical Endpoint
death/MI/stroke/urgent revascularization/stent thrombosis. Adjudicated events except death
Measured: during the 30 days of treatment
2nd Composite Clinical Endpoint
Death/MI/urgent revascularization. Adjudicated events except death
Measured: within 30 days of study
Definite Stent Thrombosis
Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. It is an adjudicated endpoint
Measured: during 30 days of treatment
TIMI Flow Grade 3 Post -PCI
TIMI) flow grade 3 is complete perfusion post-PCI.
Measured: at coroangiography post-PCI
ST Segment Elevation Resolution Post-PCI >= 70%
ST segment elevation resolution post PCI >=70% is defined as complete resolution
Measured: Between baseline and ECG 60 mn post-PCI
Thrombotic Bail-out With GPIIb/IIIa Inhibitors at Initial PCI
Glycoprotein (GP) IIb/IIIa inhibitors are often used as a rescue or bailout therapy to manage complications arising during percutaneous coronary intervention.
Measured: during PCI
Major Bleeds Within 48 Hours
non CABG related bleeds, (PLATO definition) include Life threatening and other major bleeds
Measured: within 48 hours of first dose
Minor and Major Bleedings Within 48 Hours
non CABG related bleeds (PLATO definition)
Measured: within 48 hours of first dose
Major Bleeds After 48 Hours
non CABG related bleeds (PLATO definition) include life threatening and other major bleedings
Measured: after 48hours post-first dose
Minor and Major Bleeds After 48 Hours
non CABG related bleeds (PLATO definition)
Measured: after 48 hours post first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,875 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Judith Hsia, MD, Study director, AstraZenecaPr Gilles Montalescot, Principal investigator, Pitie Salpetriere Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347580
- Sponsor's protocol ID
- D5130L00006
- Acronym
- ATLANTIC
- Status last verified
- Jul 2015
- First submitted
- 19 Apr 2011
- Last updated
- 22 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 25175921Lapostolle 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.
PubMed 30353444Fabris 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.
PubMed 30302940Bagai 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.
PubMed 29421015Kilic 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.
PubMed 29421001Venetsanos 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.
PubMed 28939567Cayla 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.
PubMed 28622941Lupi 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.
PubMed 27666002Silvain 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.
PubMed 27196998Montalescot 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.
PubMed 26952907Montalescot 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.
PubMed 23537967
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT01347580
- Acronym / sponsor ID
- ATLANTIC / D5130L00006
- Keywords
- Heart attack, heart disease, cardiovascular disease, stroke, reperfusion, pre hospital settings, ticagrelor, Percutaneous Coronary Intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,875 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 4 May 2011 (estimated)
- Results
- Posted 11 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor | Experimental | Drug: TicagrelorLoading 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 | Experimental | Drug: PlaceboPlacebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TicagrelorOral Ticagrelor loading dose (180 mg) followed by matching placebo | Drug | Ticagrelor |
| PlaceboPlacebo followed by oral Ticagrelor loading dose (180 mg) | Drug | Placebo |
Primary outcome
Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 of MI Culprit Vessel at Initial Angiography (Co-primary Endpoint)
Time frame: At initial angiography, pre PCI
(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.
ST-segment Elevation Resolution Pre PCI ≥70% (Co-primary Endpoint)
Time frame: Between baseline and PCI
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.
10 secondary outcomes
1st Composite Clinical Endpoint
Time frame: during the 30 days of treatment
2nd Composite Clinical Endpoint
Time frame: within 30 days of study
Definite Stent Thrombosis
Time frame: during 30 days of treatment
TIMI Flow Grade 3 Post -PCI
Time frame: at coroangiography post-PCI
ST Segment Elevation Resolution Post-PCI >= 70%
Time frame: Between baseline and ECG 60 mn post-PCI
Thrombotic Bail-out With GPIIb/IIIa Inhibitors at Initial PCI
Time frame: during PCI
Major Bleeds Within 48 Hours
Time frame: within 48 hours of first dose
Minor and Major Bleedings Within 48 Hours
Time frame: within 48 hours of first dose
Major Bleeds After 48 Hours
Time frame: after 48hours post-first dose
Minor and Major Bleeds After 48 Hours
Time frame: after 48 hours post first dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25175921Montalescot 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.
- Derived from this study: PubMed 30353444Lapostolle 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.
- Derived from this study: PubMed 30302940Fabris 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.
- Derived from this study: PubMed 29421015Bagai 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.
- Derived from this study: PubMed 29421001Kilic 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.
- Derived from this study: PubMed 28939567Venetsanos 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.
- Derived from this study: PubMed 28622941Cayla 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.
- Derived from this study: PubMed 27666002Lupi 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.
- Derived from this study: PubMed 27196998Silvain 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.
- Derived from this study: PubMed 26952907Montalescot 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.
- Derived from this study: PubMed 23537967Montalescot 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.
- D5130L00006\_ProtocolLink provided by the sponsor.
- D5130L00006\_CSR\_SynopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Judith Hsia, MD study director
AstraZeneca
Pr Gilles Montalescot principal investigator
Pitie Salpetriere Hospital
96 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ticagrelor in people with Myocardial Infarction and Segment Elevation Myocardial Infarction (STEMI), run by AstraZeneca at 96 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 96 sites in France, Germany, Spain, United Kingdom, Italy and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 of MI Culprit Vessel at Initial Angiography (Co-primary Endpoint) (time frame: At initial angiography, pre PCI). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01347580, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2015.