Colchicine for Acute Coronary Syndromes (COACS)

Maria Vittoria Hospital

Status and phase: Unknown; Phase 4

Conditions: Acute Coronary Syndrome

Treatments: Drug: Colchicine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01906749

2013-001415-78 (EudraCT Number)

27/06/13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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500 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Colchicine

Active Comparator group

Description:

Colchicine 0.5mg once daily for 24 months

Treatment:

Drug: Colchicine