NCT01906749

Colchicine for Acute Coronary Syndromes

Colchicine for Acute Coronary Syndromes. A Multicenter Double Blind Randomized Trial.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Maria Vittoria Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Multicenter, double blind, randomized trial to assess the effect of low-dose colchicine (0.5mg/day) on overall mortality, new coronary syndromes, and ischemic stroke at 2 years after an acute coronary syndrome. The study hypothesis is that colchicine may reduce the specified combined endpoint from 16% to 7-8% at a 2-years follow-up.

Detailed description

Multicenter, double-blind randomized trial to evaluate the efficacy of low dose colchicine (0.5mg once daily for 2 years) to reduce the incidence of subsequent overall mortality, new acute coronary syndromes, and ischemic stroke in patients admitted for an acute coronary syndrome.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	Colchicine	0.5mg once daily orally
DRUG	Placebo

Timeline

• Start date: 2013-06-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2013-07-24
• Last updated: 2013-07-24

Locations

3 sites across 1 country: Italy