Rivaroxaban Monotherapy After CYP2C19 Genotype Testing in Patients With Atrial Fibrillation and Percutaneous Coronary Intervention
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Primary ischemic endpoint
研究概览
简要总结
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 anticoagulant. Inevitably, this is associated with a higher risk of (major) bleeding. Given the reduction of ischemic risk with low-dose rivaroxaban and advances in stent properties, implantation techniques, and post-PCI management, it may be possible to treat atrial fibrillation patients after percutaneous coronary intervention with full-dose rivaroxaban and without antiplatelet therapy.
Objective: 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.
Study design: Single-centre, single arm pilot study with a stopping rule based on the occurrence of definite stent thrombosis Study population: Patients with atrial fibrillation and an indication for a non-vitamin K oral anticoagulant who undergo optimal percutaneous coronary intervention Intervention: Rivaroxaban 20 mg once daily or 15 mg once daily, in case of moderate-to-severe kidney dysfunction, for 6 or 12 months without antiplatelet therapy Main study endpoint: The primary ischemic endpoint is the composite of all-cause death, myocardial infarction, definite stent thrombosis, and ischemic stroke at 6 months after percutaneous coronary intervention. The primary bleeding endpoint is the composite of International Society on Thrombosis and Haemostasis defined major and clinically relevant non-major bleeding at 6 months after percutaneous coronary intevention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Rivaroxaban monotherapy
Once daily rivaroxaban 20 mg or 15 mg with reduced kidney function (eGFR 15 - 49 mmol/L) for 6 months in case of percutaneous coronary intervention for stable coronary artery disease or 12 months in case of percutaneous coronary intervention for acute coronary syndrome without concurrent antiplatelet therapy
干预措施: Rivaroxaban (Drug)
结局指标
主要结局
Primary ischemic endpoint
时间窗: 6 months
Composite of all-cause death, myocardial infarction, Academic Research Consortium defined definite stent trhombosis, or ischemic stroke
Primary bleeding endpoint
时间窗: 6 months
International Society on Thrombosis and Haemostasis defined major bleeding or clinically relevant non-major bleeding
次要结局
未报告次要终点
研究者
J.P.S Henriques
Professor doctor
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)