Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Atherosclerosis of Extremities
- Inflammation
- Peripheral Arterial Disease
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Double blind and use of similarly active and placebo tablets.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The LEADER-PAD trial is a randomized, double blind, multicenter pilot trial with a 2-week active run-in period, comparing low dose colchicine 0.5 mg daily with placebo in patients with PAD to prevent vascular events (myocardial infarction, stroke, cardiovascular deaths, acute limb ischemia and vascu...
The LEADER-PAD trial is a randomized, double blind, multicenter pilot trial with a 2-week active run-in period, comparing low dose colchicine 0.5 mg daily with placebo in patients with PAD to prevent vascular events (myocardial infarction, stroke, cardiovascular deaths, acute limb ischemia and vascular amputation) in patients with symptomatic peripheral artery disease. The sample size for the vanguard phase is 150 patients over 1-year accrual with a 1-year follow-up.The primary outcome is the feasibility of recruitment. If feasibility is demonstrated, patients from the vanguard phase will be rolled over into the full multicenter trial if there are no major protocol modifications.
Tracking Information
- NCT #
- NCT04774159
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Noel C Chan, MD Population Health Research Institute, Hamilton, Ontario, Canada
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