Colchicine for Acute Coronary Syndromes

• Status: Unknown status
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maria Vittoria Hospital
• Treatments: Colchicine

Criteria

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