acute coronary syndrom Anticoagulantia percutanous coronary intervention
Conditions
Interventions
Intervention and controls
Patients in the intervention group will receive Dual therapy (REDUAL like):
Dabigatran and Ticagrelor. Patients can be assigned to two treatments:
• = 80 years or GFR 30-50
Sponsors
Zuyderland Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, the investigator should have carefully considered participation of the patient after extensively consideration between high risk of bleeding and risk of thromboembolic events. Furthermore, a subject must meet all of the following criteria: • Age >= 18 years • PCI and successful stenting with a Drug Eluting Stent (DES) • Patients having an indication for a NOAC or will start with oral anticoagulation (NOAC). Patients with permanent, persistent or paroxysmal atrial fibrillation are eligible. • Written informed consent. In addition to the inclusion criteria above, all patients should meet one of the following conditions: • Admission to the hospital with ACS (unstable angina, NSTEMI, STEMI) • High risk PCI as defined by the presence of one of the following conditions: o Chronic Total Occlusion o Two-stent bifurcation laesion o Total stent length of >60mm in initial procedure o Venous graft stenting • Or the presence of medically treated type I or II diabetes mellitus
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 3x upper limit of normal) or liver disease (like hepatitis A, B, C) o Lesion or condition with a significant risk of serious bleeding, such as: * current or recent gastrointestinal ulceration; * malignant neoplasms with more bleeding risk; * recent brain / spinal cord injury; * recent surgery on the brain, spinal cord or eyes; * recent or history of intracranial haemorrhage; * oesophageal varices; * arteriovenous malformations; * vascular aneurysms; o severe intraspinal or intracerebral vascular abnormalities. o comedication with cyclosporine, itraconazole, ketoconazole (systemic) and glecaprevir / pibrentasvir, dronedarone, rifampicine, carbamazepine, St. Jan*s wort or phenytoin o Comedication with tacrolimus is not recommended. • Allergy to for Dabigatran, Ticagrelor or Clopidogrel • Pregnancy • Significant thrombocytopenia (platelet count =3 within the past 6 months. • Weight
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