A randomized trial of the effect of antiplatelet therapy (Aspirin, Aspirin and Clopidogrel or Ticagrelor) on the occurrence of atherothrombotic events following lower extremity peripheral transluminal angioplasty.
- Conditions
- antiplatelet therapy, peripheral transluminal angioplasty
- Registration Number
- NL-OMON28759
- Lead Sponsor
- Antonius Hospital Nieuwegein, Medisch Centrum Alkmaar.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 1252
All patients presented for percutaneous endovascular intervention are eligable for inclusion. (1) lesions to the iliac, femoropopliteal and below the knee (BTK) arteries; (2) eligibility of lesions for percutaneous transluminal angioplasty (PTA) or recanalization with or without additional stenting (ST), (3) all TASC lesions [16]; (4) all Rutherford (1-6) classes.
Exclusion criteria are patients with reported intolerance or hypersensitivity for the study medications, the use of anticoagulant therapy (coumarin derivatives; acenocoumarol / fenprocoumon / warfarin), the use of non-steroidal anti-inflammatory drugs in the two weeks prior to the venapuncture to determine eventual aspirin resistance, a history of platelet/bleeding abnormalities and a platelet count < 100x*10^6/dl.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint is the occurrence of the cardiovascular events myocardial infarction, in-stent thrombosis, re-intervention due to hemodynamic re-stenosis, the occurrence of cerebrovascular event (CVA or/and TIA), peripheral embolus and mortality after one year of follow-up.
- Secondary Outcome Measures
Name Time Method Secondary endpoint is occurrence of major and minor bleeding. According the TIMI criteria.