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)
|ClinicalTrials.gov Identifier: NCT01347580|
Recruitment Status : Completed
First Posted : May 4, 2011
Results First Posted : February 11, 2015
Last Update Posted : July 22, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Infarction Segment Elevation Myocardial Infarction (STEMI)||Drug: Ticagrelor Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1875 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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.|
|Study Start Date :||September 2011|
|Primary Completion Date :||November 2013|
|Study Completion Date :||November 2013|
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.
Oral Ticagrelor loading dose (180 mg) followed by matching 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 followed by oral Ticagrelor loading dose (180 mg)
- 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.
- 1st Composite Clinical Endpoint [ Time Frame: during the 30 days of treatment ]death/MI/stroke/urgent revascularization/stent thrombosis. Adjudicated events except death
- 2nd Composite Clinical Endpoint [ Time Frame: within 30 days of study ]Death/MI/urgent revascularization. Adjudicated events except death
- Definite Stent Thrombosis [ Time Frame: during 30 days of treatment ]Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. It is an adjudicated endpoint
- TIMI Flow Grade 3 Post -PCI [ Time Frame: at coroangiography post-PCI ]TIMI) flow grade 3 is complete perfusion post-PCI.
- ST Segment Elevation Resolution Post-PCI >= 70% [ Time Frame: Between baseline and ECG 60 mn post-PCI ]ST segment elevation resolution post PCI >=70% is defined as complete resolution
- Thrombotic Bail-out With GPIIb/IIIa Inhibitors at Initial PCI [ Time Frame: during PCI ]Glycoprotein (GP) IIb/IIIa inhibitors are often used as a rescue or bailout therapy to manage complications arising during percutaneous coronary intervention.
- Major Bleeds Within 48 Hours [ Time Frame: within 48 hours of first dose ]non CABG related bleeds, (PLATO definition) include Life threatening and other major bleeds
- Minor and Major Bleedings Within 48 Hours [ Time Frame: within 48 hours of first dose ]non CABG related bleeds (PLATO definition)
- Major Bleeds After 48 Hours [ Time Frame: after 48hours post-first dose ]non CABG related bleeds (PLATO definition) include life threatening and other major bleedings
- Minor and Major Bleeds After 48 Hours [ Time Frame: after 48 hours post first dose ]non CABG related bleeds (PLATO definition)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01347580
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|Study Director:||Dr Judith Hsia, MD||AstraZeneca|
|Principal Investigator:||Pr Gilles Montalescot||Pitie Salpetriere Hospital|