Conditions: Myocardial Infarction Segment Elevation Myocardial Infarction (STEMI)
Keywords: Heart attack heart disease cardiovascular disease stroke reperfusion pre hospital settings ticagrelor Percutaneous Coronary Intervention
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1875
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Ticagrelor intervention 2: Placebo
Intervention descriptions: intervention 1: Oral Ticagrelor loading dose (180 mg) followed by matching placebo intervention 2: Placebo followed by oral Ticagrelor loading dose (180 mg)

Protocol document: