The effect of antiplatelet therapy after angioplasty.

Phase 1

• Conditions: It is known that the atherothrombotic cardiovascular adverse event rate in patients with peripheral artery disease (PAD) is high. Also patency rates after (endo)vascular interventions in PAD patients are lower than in other arterial segments. In PAD patients the main focus in studies is on the technical aspects and success, while less attention has been paid to antiplatelet management, despite its significant effect on morbidity and mortality risk.; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-002086-54-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-29
• Last Update Posted: 10 September 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1806

Inclusion Criteria

All symptomatic patients ver 18 years of age with non-acute peripheral artery disease are eligible for inclusion if there is a need for percutaneous endovascular intervention.
(1) lesions of the iliac, femoropopliteal and below the knee (BTK) arteries; (2) eligibility of lesions for PTA or recanalization with or without additional stenting (ST), (3) all TASC lesions; (4) all Rutherford (1-6) classes

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 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1400

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. known CYP2C19 polymorphism.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified