Targeting Inflammation in Acute Coronary Syndrome Using Colchicine (COOL)

Hamilton Health Sciences (HHS)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Acute Coronary Syndrome

Treatments: Drug: Placebo; Drug: Colchicine

Study type: Interventional

Funder types: Other

Identifiers

NCT00754819

COL0001

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Colchicine 1mg daily oral

Treatment:

Drug: Colchicine

2

Placebo Comparator group

Description:

Placebo 1 capsule daily oral

Treatment:

Drug: Placebo