Non-ST elevation myocardial infarction (coronary artery disease)
Conditions
Interventions
Treatment before PCI:
• Patients will be treated with a loading dose of 60 mg prasugrel, 180 mg
ticagrelor or 600mg clopidogrel at least 2 hours prior to coronary angiography.
Treatment after PCI:
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients aged 18 years or older are eligible for inclusion if all of the following criteria are met: - Clinical diagnosis of NSTE-ACS (i.e. NSTEMI or unstable angina) - Successful PCI (according to the treating physician) with implantation of new generation drugeluting stents. - CYP2C19 extensive metabolizer
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Known allergy or contraindication for aspirin or clopidogrel. • Concurrent use of oral anticoagulants (e.g. because of atrial fibrillation) • Ongoing indication for DAPT at admission (e.g. due to recent PCI or ACS) • High-risk features for PCI including left main disease, chronic total occlusion, bifurcation lesion requiring 2-stent treatment, saphenous or arterial graft lesion, severely calcified lesion requiring the use of the Rotablator system, >=3 treated vessels, >= 3 stents implanted and total stent length >60 mm • Recent stroke, transient ischemic attack (TIA) or intracranial bleeding • Severe hepatic impairment (Child Pugh class C) • Planned surgical intervention within 6 months of PCI • Patients requiring staged procedure (to avoid heterogeneity in the duration of pharmacological treatment between index and staged procedures) • Pregnant or breastfeeding women at time of enrolment • Participation in another trial with an investigational drug or device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary ischemic endpoints at 6 months is the composite of: • All-cause mortality • Myocardial infarction • Academic Research Consortium (ARC) defined definite or probable stent thrombosis • Ischemic stroke The primary bleeding endpoint at 6 months is: • Major or minor bleeding defined as Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will include: • Primary ischemic and bleeding endpoint at 6 months • Each individual component of the primary endpoints at 6 months • Cardiovascular mortality at 3 and 6 months • Non-cardiovascular mortality at 3 and 6 months • Any need for revascularization at 3 and 6 months • Any periprocedural complications | — |
Countries
Netherlands
Outcome results
None listed