Rivaroxaban Monotherapy and CYP2C19 Genotype Testing in Patients with Atrial Fibrillation and Percutaneous Coronary Interventio
- Conditions
- Coronary artery disease, Percutaneous coronary intervention, Atrial fibrillationTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2023-508904-39-00
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
Age =18 years, Successful PCI, History of or newly diagnosed (<72 hours after PCI/ACS) AF or atrial flutter with a long-term (= 1 year) indication for OAC, Treatment with a loading dose of clopidogrel prior to or during PCI
Known allergy or contraindication for rivaroxaban, Mechanical heart valve prosthesis, Moderate to severe mitral valve stenosis (AVA =1.5 cm2), Intracardiac thrombus or apical aneurysm requiring OAC, Kidney failure (eGFR <15), Active liver disease (ALT, ASP, AP >3x ULN or active hepatitis A, B or C), Active malignancy excluding non-melanoma skin cancer, Suboptimal stenting result based on angiographic and optional intra-coronary imaging input, Systemic treatment with strong inhibitors or inducers of both cytochrome P450 (CYP) 3A4 and p-glycoproteine (P-gp; e.g. ketoconazole or carbamazepine), Active bleeding on randomization, Severe anaemia requiring blood transfusion, Pregnancy or breast-feeding women, Planned high-bleeding risk surgical intervention within 6 months after PCI for stable CAD and 12 months after PCI for ACS, PCI of left main disease, chronic total occlusion, bifurcation lesion requiring two-stent treatment, saphenous or arterial graft lesion, severely calcified lesions, Participation in another trial with an investigational drug or device (i.e. stent, Current indication for OAC besides atrial fibrillation/flutter (e.g. venous thromboembolism), Overwriting indication for DAPT (e.g. TIA/CVA or PAD)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method