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Colchicine for Acute Coronary Syndromes (COACS)

M

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

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

Trial contacts and locations

3

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Central trial contact

Massimo Imazio, MD

Data sourced from clinicaltrials.gov

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