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

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 - CLEAR-PATH study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56168

Enrollment

1696

Registered

2022-05-27

Start date

2022-08-24

Completion date

Unknown

Last updated

2024-04-15

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 Narrowed/blockage of arteries in the lower extremities

Interventions

The intervention is comparing two groups: clopidogrel monotherapy (75 mg) plus placebo daily versus dual therapy clopidogrel (75 mg)/aspirin (80 mg) daily.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The primary endpoint is all-cause death and the occurrence of cardiovascular adverse events after 1 year: re-intervention due to any restenosis or re-occlusion or due to acute limb ischemia, the occurrence of any amputation, cerebrovascular event, myocardial infarction, or cardiovascular death.	—

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)