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Peripheral Arterial DiseaseBrain and nervesDrugPhase 3

What this study is

The Low dose ColchicinE in pAtients with peripheral Artery DiseasE to address residual vascular Risk (LEADER-PAD) trial will evaluate if anti-inflammatory therapy with colchicine will reduce vascular events in patients with symptomatic peripheral artery disease.

What's being tested

  • Colchicine 0.5 MG Oral Tablet

    Intervention · DRUG

    Colchicine 0.5 mg tablet daily Active drug and placebo are of the same appearance and are indistinguishable. All investigators, study personnel and patients will be blinded to drug treatment assignment. Trial treatment supplies must be stored in a secure, limited-access location under the storage conditions specified on the IP supply label.

  • Colchicine-Placebo

    Intervention · DRUG

    Colchicine-Placebo tablet

Study details

Official title
Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk: A Randomized Trial
Sponsor
Population Health Research Institute
Conditions
Peripheral Arterial Disease · Atherosclerosis of Extremities · Inflammation
Enrolling
6,150 people
Starts
2021-05-06
Est. completion
2029-12
Design
Quadruple-blind, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗