Genotype-guided strategy for antithrombotic treatment versus conventional clopidogrel therapy in peripheral arterial disease (GENPAD)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,276
- 试验地点
- 17
- 主要终点
- The primary outcome is the occurrence of adverse clinical events related to arterial thrombosis at 24 months, including death from any cause, major adverse cardiovascular events (MACE) and major adverse limb events (MALE).
研究概览
简要总结
to evaluate the ability of genotypeguided antithrombotic treatment to reduce adverse clinical events related to arterial thrombosis in PAD patients. Adverse clinical events of interest are major adverse cardiovascular events (myocardial infarction, stroke, transient ischemic arrack), major adverse limb events (acute/chronic limb ischemia of peripheral vascular intervention including amputation) and death.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age > 16 years
- •Indication for monotherapy clopidogrel 75mg once daily
- •Ankle-brachial index < 0.9 and/or toe brachial index < 0.5
- •Current or previous symptoms due to insufficient vascularization of one or two lower extremities, including intermittent claudication, pain at rest and/or gangrene (Rutherford category 1-6)
- •Consulting a vascular surgeon for diagnosis, treatment and/or follow-up of PAD
排除标准
- •known CYP2C19 genotype or metabolizer state
- •treated with coumarins, Non-vitamin K Oral Anti-Coagulants, unfractionated heparin, low molecular weight heparins or double antiplatelet therapy with acetylsalicylic acid and a P2Y12 inhibitor for other indications
- •contraindication for clopidogrel, acetylsalicylic acid and/or rivaroxaban
- •pregnant or breastfeeding women
结局指标
主要结局
The primary outcome is the occurrence of adverse clinical events related to arterial thrombosis at 24 months, including death from any cause, major adverse cardiovascular events (MACE) and major adverse limb events (MALE).
The primary outcome is the occurrence of adverse clinical events related to arterial thrombosis at 24 months, including death from any cause, major adverse cardiovascular events (MACE) and major adverse limb events (MALE).
次要结局
未报告次要终点
研究者
Michiel Warle
Scientific
Radboud universitair medisch centrum Stichting