A randomized trial studying the effect of antiplatelet therapy (clopidogrel, clopidogrel/ascal) on the prevention of atherothrombotic events after peripheral angioplasty

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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-006611-29-NL

Enrollment

1696

Registered

2022-06-03

Start date

2022-06-28

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

(Chronic) Peripheral (occlusive) arterial disease (PAD)

Interventions

Trade Name: Clopidogrel (Clopidogrel, Grepid, Iscover, plavix) Pharmaceutical Form: Tablet Trade Name: acetylsalicylzuur (acetylsalicylzuur cardio) Pharmaceutical Form: Tablet Pharmaceutical form of

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to assess whether and to what extent dual therapy clopidogrel/aspirin (80 mg) is superior to clopidogrel (75mg daily) alone, in reducing cardiovascular adverse events after one-year follow-up in PAD patients who underwent endovascular treatment.;Secondary Objective: It is also determined if non-responsiveness to clopidogrel predicts outcome. CYP2C19 polymorphisms will be determined at the end of the trial. The findings will not change clinical practice within the course of the trial.;Primary end point(s): The primary endpoint is the occurrence of cardiovascular adverse events after one year: re-intervention due to any restenosis or re-occlusion of the target lesion or acute limb ischemia, the occurrence of any amputation, cerebrovascular event, myocardial infarction, or cardiovascular death. ;Timepoint(s) of evaluation of this end point: After one year	—

Measure

Time frame

Main Objective: The primary objective is to assess whether and to what extent dual therapy clopidogrel/aspirin (80 mg) is superior to clopidogrel (75mg daily) alone, in reducing cardiovascular adverse events after one-year follow-up in PAD patients who underwent endovascular treatment.;Secondary Objective: It is also determined if non-responsiveness to clopidogrel predicts outcome. CYP2C19 polymorphisms will be determined at the end of the trial. The findings will not change clinical practice within the course of the trial.;Primary end point(s): The primary endpoint is the occurrence of cardiovascular adverse events after one year: re-intervention due to any restenosis or re-occlusion of the target lesion or acute limb ischemia, the occurrence of any amputation, cerebrovascular event, myocardial infarction, or cardiovascular death. ;Timepoint(s) of evaluation of this end point: After one year

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoint is the occurrence of major and minor bleeding. According to the Thrombolysis In Myocardial Infarction (TIMI) criteria or Bleeding Academic Research Consortium (BARC) criteria;Timepoint(s) of evaluation of this end point: After one year.	—

Countries

Netherlands

Contacts

Public ContactClinical trial office

University Medical Centre Utrecht

trialbureaucancercenter@umcutrecht.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026