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

Recruiting

Conditions: (chronic) peripheral (occlusive) arterial disease
Narrowed/blockage of arteries in the lower extremities
10003216

Registration Number: NL-OMON56168

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 1696

Inclusion Criteria

To be eligible to participate in this study, a subject must meet all of the
following criteria:
1. Lesions of the iliac, femoropopliteal, and/or below-the-knee (BTK) arteries;
2. At least one TASC lesion;
3. Rutherford (1-6) classes with an indication for an endovascular intervention;
4. Proficient understanding of the consequences of enrolment by the patient;
5. Written informed consent by the patient;
6. Age >= 45 years.
And:
7. Eligibility of lesions for;
a. Percutaneous transluminal angioplasty (PTA) or recanalization with or
without additional stenting based on prevailing guidelines, or;
b. Hybrid procedure with an endarterectomy of the common femoral artery and
additional iliac, femoral or tibial PTA, or;
c. A reintervention within 2 months due to a phased treatment.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
1. Acute (limb) ischemia
2. Reported intolerance or hypersensitivity to the study medications
3. Use of anticoagulant therapy (DOACs or coumarin)
4. Use of non-steroidal anti-inflammatory drugs >2 weeks which cannot be
discontinued
5. Patients incompetent of understanding the consequences of enrolment in the
trial.
5.6. Patients with a reintervention due to restenosis/reocclusion within 2
months
7. Patients with a hybrid procedure other than endarterectomy of the common
femoral artery such as femoral bypass
8. Patients with coagulopathy
9. Patients with a peptic ulcer confirmed by an esophagogastroduodenoscopy in
their medical history
10. Patients who are pregnant/contemplating pregnancy/nursing.
11. Patients requiring dialysis
12. Patients with liver failure and at least one of the following criteria;
a. elevated INR value, or;
b. portal hypertension, or;
c. thrombocytopenia <50x10^9/L, or;
d. INR, portal tension, or platelet count are unknown.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is all-cause death and the occurrence of cardiovascular<br /><br>adverse events after 1 year: re-intervention due to any restenosis or<br /><br>re-occlusion or due to acute limb ischemia, the occurrence of any amputation,<br /><br>cerebrovascular event, myocardial infarction, or cardiovascular death.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoint is the occurrence of all and major bleeding (following<br /><br>the TIMI bleeding classification and BARC criteria), major adverse<br /><br>cardiovascular events (MACE), and major adverse limb events (MALE). CYP2C19<br /><br>polymorphisms will be determined to examine if non-responsiveness to<br /><br>clopidogrel predicts outcome. The findings will not change clinical practice<br /><br>within the course of the trial.</p><br>