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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Ticagrelor monotherapy for 12 months
Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months
Noordwest Ziekenhuisgroep Alkmaar
Alkmaar, Netherlands
Amsterdam UMC
Amsterdam, Netherlands
Rijnstate
Arnhem, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
Radboudumc
Nijmegen, Netherlands
Composite of major adverse cardiac and cerebral events (MACCE)
Consisting of: myocardial infarction, stent thrombosis, ischemic stroke, cardiovascular mortality / all-cause mortality
Time frame: 3 and 13 months after primary PCI
Intramyocardial haemorrhage (IMH)
Size of IMH and infarct determined by Cardiac Magnetic Resonance imaging at day 5-8 post primary PCI.
Time frame: day 5-8 post primary PCI
Bleeding complications
Defined as Bleeding Academic Research Consortium (BARC) 2 or greater
Time frame: 3 and 13 months after primary PCI
All-cause mortality
Time frame: 3 and 13 months after primary PCI
Platelet reactivity
Differences in platelet reactivity between ticagrelor monotherapy and ticagrelor + aspirin will be measured as Aspirin Reaction Units (ARU) using the VerifyNow test.
Time frame: 5-8 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.