Colchicine for Acute Coronary Syndromes

Phase 4

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Placebo; Drug: Colchicine

• Registration Number: NCT01906749
• Lead Sponsor: Maria Vittoria Hospital

Brief 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.

Study Timeline

• Study Start: 2013-06
• Status Verified: 2013-07
• Study First Submitted: 2013-07-21
• Study First Submitted QC: 2013-07-23
• Last Update Submitted: 2013-07-23
• Study First Posted: 2013-07-24
• Last Update Posted: 2013-07-24
• Primary Completion: 2016-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• >18years
• Acute coronary syndrome (unstable angina or acute myocardial infarction)
• Life expectancy> 2 years
• Absence of contraindications to colchicine

Exclusion Criteria

• Colchicine treatment for any cause
• Severe liver disease
• Renal insufficiency with creatinine>150mmol/l or creatinine clearance<30ml/min/1.73m2
• Known cancer
• Chronic inflammatory bowel disease
• treatment with cyclosporine
• allergy or hypersensitivity to colchicine
• pregnancy or lactating woman or woman with childbearing potential without valid contraception

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Colchicine	Colchicine	Colchicine 0.5mg once daily for 24 months

Primary Outcome Measures

Name	Time	Method
Overall mortality, new acute coronary syndrome, and ischemic stroke.	24 months

Secondary Outcome Measures

Name	Time	Method
Mortality	24 months	Secondary outcome measures will contain each issue of the combined primary endpoint as separate outcome.
New acute coronary syndrome (unstable angina and myocardial infarction)	24 months
Ischemic Stroke	24 months

Trial Locations

Locations (3)

Cardiology Dpt.Maria Vittoria Hospital; 🇮🇹 Torino, Italy

Cardiology Dpt.San Giovanni Bosco Hospital; 🇮🇹 Torino, Italy

Cardiology Dpt.; 🇮🇹 Rivoli, Torino, Italy