Rivaroxaban Monotherapy and CYP2C19 Genotype Testing in Patients with Atrial Fibrillation and Percutaneous Coronary Intervention

Amsterdam UMC0 个研究点目标入组 50 人开始时间: 2023年11月7日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•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)

发起方

Amsterdam UMC