Status:
UNKNOWN
Rivaroxaban Monotherapy After CYP2C19 Genotype Testing in Patients With Atrial Fibrillation and Percutaneous Coronary Intervention
Lead Sponsor:
J.P.S Henriques
Conditions:
Atrial Fibrillation
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Rationale: Patients with atrial fibrillation who undergo percutaneous coronary intervention for coronary artery disease are treated with antiplatelet therapy on top of a non-vitamin K oral anticoagula...
Eligibility Criteria
Inclusion
- 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 and aspirin prior to or during PCI
Exclusion
- Known allergy or contraindication for rivaroxaban
- Current indication for OAC besides atrial fibrillation/flutter (e.g. venous thromboembolism)
- Overwriting indication for DAPT (e.g. TIA/CVA or PAD)
- 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
- 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)
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06103266
Start Date
January 1 2024
End Date
December 1 2025
Last Update
October 26 2023
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.