Colchicine for Acute Coronary Syndromes

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01906749

Acronym

COACS

Enrollment

500

Registered

2013-07-24

Start date

2013-06-30

Completion date

2016-06-30

Last updated

2013-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Keywords

Acute coronary syndrome, Colchicine

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.

Interventions

DRUGColchicine

0.5mg once daily orally

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame
Overall mortality, new acute coronary syndrome, and ischemic stroke.	24 months

Secondary

Measure	Time frame	Description
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	—

Countries

Italy

Contacts

Primary ContactMassimo Imazio, MD

massimo_imazio@yahoo.it+39011439

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026