CIRCLE-Asia Phase 3 Trial: Colchicine for Chronic Limb-Threatening Ischemia
ClinicalTrials.gov Studies
Summary
The CIRCLE-Asia trial (NCT07536373) is a Phase 3 randomized, double-blind, placebo-controlled multicenter study evaluating colchicine 0.5mg daily versus placebo in 200 adult patients with chronic limb-threatening ischemia who have undergone successful revascularization. The trial will be conducted at five hospitals in Taiwan with treatment beginning within 7 days of the procedure. Participants will be monitored for reduction of complications and limb events.
What changed
ClinicalTrials.gov registration entry for CIRCLE-Asia Phase 3 trial (NCT07536373) studying colchicine 0.5mg daily versus placebo in 200 patients with chronic limb-threatening ischemia who have undergone revascularization. The pilot study will assess whether colchicine reduces complications and limb events through its anti-inflammatory properties.\n\nFor pharmaceutical manufacturers, clinical investigators, and healthcare providers, this registration signals ongoing research into anti-inflammatory applications for peripheral artery disease. No compliance obligations are created by this registry entry.
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Apr 17, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Colchicine in Chronic Limb-Threatening Ischemia
Phase 3 NCT07536373 Kind: PHASE3 Apr 17, 2026
Abstract
Chronic limb-threatening ischemia (CLTI) is the most severe form of peripheral artery disease, a condition in which narrowed or blocked arteries reduce blood flow to the legs. People with CLTI may have severe leg pain at rest, non-healing wounds, or gangrene, and face a high risk of leg amputation and death. Even after successful procedures to restore blood flow to the leg (called revascularization), many patients still experience serious complications. Inflammation in the blood vessels is believed to play an important role in these poor outcomes.
Colchicine is an anti-inflammatory medication that has been used safely for decades to treat gout and other inflammatory conditions. Recent large clinical trials have shown that a low dose of colchicine (0.5 mg per day) can reduce heart attacks and strokes in patients with coronary artery disease. However, it has not been studied in patients with CLTI.
The CIRCLE-Asia trial (Colchicine in Chronic Limb-Threatening Ischemia for Reduction of Complications and Limb Events in Asia) is a pilot study designed to evaluate whether colchicine can improve outcomes in patients with CLTI who have recently undergone a successful procedure to restore blood flow to their leg. Treatment begins within 7 days of the procedure.
This is a randomized, double-blind, placebo-controlled, multicenter trial conducted at five hospitals in Taiwan. A total of 200 adult patients with CLTI who have undergone successful revascularization will be randomly assi...
Conditions: Chronic Limb-Threatening Ischemia
Interventions: Colchicine 0.5 MG Oral Tablet Once Daily, Placebo
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