NL-OMON56168招募中不适用
A randomized placebo-controlled double-blind trial studying the effect of single antiplatelet therapy (clopidogrel) versus dual antiplatelet therapy (clopidogrel + aspirin) on the occurrence of atherothrombotic events following lower extremity peripheral transluminal angioplasty - CLEAR-PATH study
niversitair Medisch Centrum Utrecht0 个研究点目标入组 1,696 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,696
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •To be eligible to participate in this study, a subject must meet all of the
- •following criteria:
- •1. Lesions of the iliac, femoropopliteal, and/or below-the-knee (BTK) arteries;
- •2. At least one TASC lesion;
- •3. Rutherford (1-6) classes with an indication for an endovascular intervention;
- •4. Proficient understanding of the consequences of enrolment by the patient;
- •5. Written informed consent by the patient;
- •6. Age >= 45 years.
- •7. Eligibility of lesions for;
- •a. Percutaneous transluminal angioplasty (PTA) or recanalization with or
- •without additional stenting based on prevailing guidelines, or;
- •b. Hybrid procedure with an endarterectomy of the common femoral artery and
- •additional iliac, femoral or tibial PTA, or;
- •c. A reintervention within 2 months due to a phased treatment.
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •1. Acute (limb) ischemia
- •2. Reported intolerance or hypersensitivity to the study medications
- •3. Use of anticoagulant therapy (DOACs or coumarin)
- •4. Use of non-steroidal anti-inflammatory drugs >2 weeks which cannot be
- •discontinued
- •5. Patients incompetent of understanding the consequences of enrolment in the
- •5.6. Patients with a reintervention due to restenosis/reocclusion within 2
- •7. Patients with a hybrid procedure other than endarterectomy of the common
- •femoral artery such as femoral bypass
- •8. Patients with coagulopathy
- •9. Patients with a peptic ulcer confirmed by an esophagogastroduodenoscopy in
- •their medical history
- •10. Patients who are pregnant/contemplating pregnancy/nursing.
- •11. Patients requiring dialysis
- •12. Patients with liver failure and at least one of the following criteria;
- •a. elevated INR value, or;
- •b. portal hypertension, or;
- •c. thrombocytopenia <50x10^9/L, or;
- •d. INR, portal tension, or platelet count are unknown.
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