Targeting Inflammation in Acute Coronary Syndrome Using Colchicine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Colchicine 1mg daily oral

Group Type ACTIVE_COMPARATOR

Colchicine

Intervention Type DRUG

1mg once daily

2

Placebo 1 capsule daily oral

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 capsule daily

Interventions

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Colchicine

1mg once daily

Intervention Type DRUG

Placebo

1 capsule daily

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No