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Rivaroxaban Monotherapy and CYP2C19 Genotype Testing in Patients with Atrial Fibrillation and Percutaneous Coronary Intervention
EU CTIS ID: 2023-508904-39-00
What this study is testing
This study will serve as a pilot to investigate the feasibility and safety of rivaroxaban monotherapy in 50 patients with atrial fibrillation after percutaneous coronary intervention.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility criteria
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.