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.
- Myocardial Infarction
- Percutaneous Coronary Intervention
- Segment Elevation Myocardial Infarction (STEMI)
- Placebo Drug
Intervention Desc: Placebo followed by oral Ticagrelor loading dose (180 mg) ARM 1: Kind: Experimental Label: Placebo Description: 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.
- Ticagrelor Drug
Intervention Desc: Oral Ticagrelor loading dose (180 mg) followed by matching placebo ARM 1: Kind: Experimental Label: Ticagrelor Description: 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.
- Allocation: Randomized
- Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Safety Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Thrombolysis In Myocardial Infarction (TIMI) flow grade 3 of MI culprit vessel at initial angiography (co-primary endpoint)||At initial angiography, pre PCI||No|
|Primary||ST-segment resolution up to pre PCI ≥70% (co-primary endpoint)||Between baseline and PCI||No|
|Secondary||Percentage of patients with composite of death||during the 30 days of treatment||No|
|Secondary||Percentage of patients presenting an acute stent thrombosis episode||during 30 days of treatment||No|
|Secondary||The total number of patients with major life-threatening bleeding events||within the first 48 hours and during 30 days of treatment||No|
|Secondary||Total number of patients with other major bleeding events||within the first 48 hours and during 30 days of treatment||No|
|Secondary||Total number of patients with minor or major bleeding events||within the first 48 hours and during 30 days of treatment||No|
|Secondary||Percentage of patients with MI||during the 30 days of treatment||No|
|Secondary||Percentage of patients with urgent revascularization||during the 30 days of treatment||No|
|Primary||ST-segment Elevation Resolution Pre PCI ≥70% (Co-primary Endpoint)||Between baseline and PCI||No|
|Secondary||1st Composite Clinical Endpoint||during the 30 days of treatment||No|
|Secondary||2nd Composite Clinical Endpoint||within 30 days of study||No|
|Secondary||Definite Stent Thrombosis||during 30 days of treatment||No|
|Secondary||TIMI Flow Grade 3 Post -PCI||at coroangiography post-PCI||No|
|Secondary||ST Segment Elevation Resolution Post-PCI >= 70%||Between baseline and ECG 60 mn post-PCI||No|
|Secondary||Thrombotic Bail-out With GPIIb/IIIa Inhibitors at Initial PCI||during PCI||No|
|Secondary||Major Bleeds Within 48 Hours||within 48 hours of first dose||No|
|Secondary||Minor and Major Bleedings Within 48 Hours||within 48 hours of first dose||No|
|Secondary||Major Bleeds After 48 Hours||after 48hours post-first dose||No|
|Secondary||Minor and Major Bleeds After 48 Hours||after 48 hours post first dose||No|
- AstraZeneca Lead