A randomized trial studying the effect of antiplatelet therapy (clopidogrel, clopidogrel/ascal) on the prevention of atherothrombotic events after peripheral angioplasty
- Conditions
- (Chronic) Peripheral (occlusive) arterial disease (PAD)Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2021-006611-29-NL
- Lead Sponsor
- niversity Medical Centre Utrecht Department of Vascular Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 1696
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method