Rivaroxaban Monotherapy and CYP2C19 Genotype Testing in Patients with Atrial Fibrillation and Percutaneous Coronary Intervention
Key facts
- Where
- Amsterdam, HollandiaSee the site
- Phase
- 4. fázis
Where in Hollandia
- Amsterdam UMCAmsterdam, HollandiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Amsterdam UMC
- Trial code
- EU 2023-508904-39-00
- Record updated
- 2024. június 21.
- Original description
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.Read full original descriptionShow less
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.
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 prior to or during PCI.
Exclusion: Systemic treatment with strong inhibitors or inducers of both cytochrome P450 (CYP) 3A4 and p-glycoproteine (P-gp; e.g. ketoconazole or carbamazepine); Participation in another trial with an investigational drug or device (i.e. stent; Known allergy or contraindication for rivaroxaban; Mechanical heart valve prosthesis; Active malignancy excluding non-melanoma skin cancer; Active bleeding on randomization; 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; Current indication for OAC besides atrial fibrillation/flutter (e.g. venous thromboembolism); Kidney failure (eGFR <15); Active liver disease (ALT, ASP, AP >3x ULN or active hepatitis A, B or C); Moderate to severe mitral valve stenosis (AVA ≤1.5 cm2); Intracardiac thrombus or apical aneurysm requiring OAC; Suboptimal stenting result based on angiographic and optional intra-coronary imaging input; Severe anaemia requiring blood transfusion; Pregnancy or breast-feeding women; Overwriting indication for DAPT (e.g. TIA/CVA or PAD).