Colchicine for Acute Coronary Syndromes

Acute Coronary Syndrome Clinical Trial

— COACS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01906749
• Other study ID #: 27/06/13
• Secondary ID: 2013-001415-78
• Status: Recruiting
• Phase: Phase 4
• First received: July 21, 2013
• Last updated: July 23, 2013
• Start date: June 2013
• Est. completion date: June 2016

Study information

• Verified date: July 2013
• Source: Maria Vittoria Hospital
• Contact: Massimo Imazio, MD
• Phone: +39011439
• Email: massimo_imazio[@]yahoo.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Colchicine
0.5mg once daily orally
• Placebo

Locations

Country	Name	City	State
Italy	Cardiology Dpt.	Rivoli	Torino
Italy	Cardiology Dpt.Maria Vittoria Hospital	Torino
Italy	Cardiology Dpt.San Giovanni Bosco Hospital	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Maria Vittoria Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall mortality, new acute coronary syndrome, and ischemic stroke.		24 months	No
Secondary	Mortality	Secondary outcome measures will contain each issue of the combined primary endpoint as separate outcome.	24 months	No
Secondary	New acute coronary syndrome (unstable angina and myocardial infarction)		24 months	No
Secondary	Ischemic Stroke		24 months	No