Targeting Inflammation in Acute Coronary Syndrome Using Colchicine

Colchicine Compared With Placebo to Reduce Hs-CRP in Patients With Acute Coronary Syndromes- Targeting Inflammation in Atherosclerosis Trial

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00754819

Acronym

COOL

Enrollment

Registered

2008-09-18

Start date

2008-04-30

Completion date

2009-09-30

Last updated

2009-10-08

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

Conditions

Acute Coronary Syndrome

Brief summary

The purpose of this study is to evaluate the effect of colchicine on high sensitivity C-reactive protein (hs-CRP), a blood marker to measure inflammation, in patients with acute coronary syndromes.

Interventions

DRUGColchicine

1mg once daily

DRUGPlacebo

1 capsule daily

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 85 Years

Healthy volunteers

Inclusion criteria

* All patients with a diagnosis of acute coronary syndrome who are \> 18 years old and who do not have any contraindication to colchicine.

Exclusion criteria

* Contraindication to colchicine including any of the following: * hypersensitivity to colchicine * severe renal, hepatic or gastrointestinal disorder * blood dyscrasias (myelodysplasia cytopenias etc) * Concurrent use of moderate-strong CYP3A4 inhibitors (a complete list is appended in the full protocol) * Known severe liver disease and/or elevated transaminases \> 1.5x the upper limit of normal * Estimated GFR \< 50 ml/min * Pregnant or lactating women or women not protected by a reliable contraception method * Current treatment with colchicine at enrollment * Active infection or systemic inflammation eg active rheumatoid arthritis

Design outcomes

Primary

Measure	Time frame
To determine the effect of low dose colchicine on hs-CRP.	30 days

Secondary

Measure	Time frame
To determine the effect of colchicine on (a)platelet function and (b)short-term risk (30 days) of cardiovascular events	30 days

Countries

Canada

Outcome results

None listed

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