Anticoagulantia percutanous coronary intervention
Conditions
Interventions
None listed
Sponsors
Zuyderland Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Age * 18 years * Patients having an indication for a NOAC or will start with oral anticoagulation (NOAC). Permanent, persistent or paroxysmal atrial fibrillation are eligible. * PCI and successful stenting with DES for ACS (unstable angina pectoris, NSTEMI, STEMI) * Written informed consent.
Exclusion criteria
Exclusion criteria: * Patients unable or unwilling to comply with the protocol or with life expectancy shorter than the duration of the study * Glomerular filtration rate < 30 ml/min * Heart valve prosthesis (mechanical or biological) * Cardiogenic shock * Contra-indication for NOAC, Aspirin or Clopidogrel * Allergy to for NOAC, Aspirin or Clopidogrel * Pregnancy * Previous intracerebral haemorrhage * Significant thrombocytopenia (platelet count < 50x10 9/L) * Major bleeding according to BARC *3 within the past 12 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the first bleeding event (major and clinically relevant non-major), as defined by the Bleeding Academic Research Council (BARC) score *2 in the 12 months follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are efficacy endpoints of thromboembolic events (myocardial infarction, stroke, systemic embolism) and death. Other secondary endpoints are a composite endpoint of thromboembolic events or death, as well as the individual thromboembolic events and stent thrombosis. | — |
Countries
Netherlands
Outcome results
None listed