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.

Phase 4

Completed

Conditions: claudicatio
peripheral arterial disease
10003216

Registration Number: NL-OMON47750

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 1806

Inclusion Criteria

All patients of 18 and over with: (1) lesions to the iliac,
femoropopliteal or 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

Exclusion criteria are acute ischemia, PAD due to aneurysm abdominal or
popliteal, patients with reported intolerance or hypersensitivity for the study
medications, impossibility of discontinuing current antiplatelet therapy, 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 venepuncture to determine eventual aspirin resistance, a history
of platelet/bleeding abnormalities, a platelet count < 100x*10^6/dl and
patients with a life expectancy less than one year.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is the occurrence of cardiovascular adverse events:<br /><br>thrombo-embolic events, re-stenosis and occlusion, re-intervention due to<br /><br>symptomatic restenosis or re-occlusion, the occurrence of cerebrovascular<br /><br>events, myocardial infarction, and mortality after one year of follow-up. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoint is occurrence of major and/or minor bleeding. Also it is<br /><br>determined if CYP2C19 polymorphisms and non-responsiveness to aspirin or<br /><br>clopidogrel predicts outcome. The results of these tests are blinded for<br /><br>physicians. </p><br>