A randomized placebo-controlled double-blind trial studying the effect of antiplatelet monotherapy (clopidogrel) versus dual antiplatelet therapy (clopidogrel + aspirin) on the occurrence of atherothrombotic events following lower extremity peripheral transluminal angioplasty - CLEAR-PATH study

niversity Medical Centre Utrecht Department of Vascular Surgery0 个研究点目标入组 1,696 人开始时间: 2022年6月3日最近更新: 2024年3月4日

试验速览

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•In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•- Lesions of the iliac, femoropopliteal and/or below-the-knee (BTK) arteries
•- Eligibility of lesions for percutaneous transluminal angioplasty (PTA) or recanalization with or without additional stenting based on prevailing guidelines
•- Hybrid procedure with an endarterectomy of the common femoral artery and additional iliac, femoral or tibial PTA
•- All TASC lesions
•- Rutherford (3-6) classes
•- Proficient understanding of the consequences of enrolment
•- Age =18 years
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 339
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1357

•A potential subject who meets any of the following criteria will be excluded from participation in this study:
•- Acute (limb) ischemia
•- Reported intolerance or hypersensitivity for the study medications
•- Use of anticoagulant therapy (DOACs and coumarin)
•- Use of non-steroidal anti-inflammatory drugs >2 weeks
•- A history of platelet/bleeding abnormalities
•- Patient with malignancy and therefore a life expectancy less than one year
•- Patients incompetent of understanding the consequences of enrolment in the trial.
•- Patients with a previous intervention in the target lesion within 3 months
•- Patients with a hybrid procedure such as femoral bypass and an iliac or tibial PTA

发起方

niversity Medical Centre Utrecht Department of Vascular Surgery