The main goal of this clinical trial is to assess whether direct omission of aspirin after Percutaneous Coronary Intervention (PCI) with the continuation of ticagrelor monotherapy for 12 months versus 12 months ticagrelor plus aspirin is equally safe regarding the incidence of ischemic events in patients with ST elevation myocardial infarction (STEMI). Furthermore, the two treatment strategies will be compared regarding the incidence and extent of intramyocardial haemorrhage (IMH) and infarct size in the first week after PCI as determined with Cardiac Magnetic Resonance (CMR). The secondary efficacy endpoint consists of clinical bleeding events and all-cause mortality. The main analyses will comprise of clinical outcomes in the first three months after primary PCI and of CMR results. In addition, we will report on clinical outcomes at thirteen months.
Clinical and electrocardiographical diagnosis of STEMI
Successful PCI (according to the treating physician) of the infarct-related vessel with a modern drug-eluting stent (DES)
Known allergy or contraindication for aspirin, ticagrelor or prasugrel.
Previous PCI or MI less than 12 months ago
Previous cardiac surgery
Participation in another clinical cardiology study or study concerning platelet aggregation/ thrombosis. (unless the antithrombotic therapy prescribed in this other study will end due to clinical reasons (e.g. the STEMI))
Parallel
Ticagrelor
DrugTicagrelor monotherapy for 12 months
Aspirin
DrugDual antiplatelet therapy (aspirin plus ticagrelor) for 12 months
Composite of major adverse cardiac and cerebral events (MACCE)
Consisting of: myocardial infarction, stent thrombosis, ischemic stroke, cardiovascular mortality / all-cause mortality
Intramyocardial haemorrhage (IMH)
Size of IMH and infarct determined by Cardiac Magnetic Resonance imaging at day 5-8 post primary PCI.
Bleeding complications
Defined as Bleeding Academic Research Consortium (BARC) 2 or greater
All-cause mortality
Platelet reactivity
Differences in platelet reactivity between ticagrelor monotherapy and ticagrelor + aspirin will be measured as Aspirin Reaction Units (ARU) using the VerifyNow test.
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