COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 Trial)

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-07-31

Brief Summary

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This is a multicenter, double-blind, randomized trial to assess the efficacy and safety of colchicine for post-pericardiotomy syndrome prevention, post-operative effusions prevention, and post-operative atrial fibrillation prevention.

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Detailed Description

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This is a multi center, double-blind, randomized trial to test the efficacy and safety of colchicine for prevention of post-pericardiotomy syndrome, post-operative effusions, and post-operative atrial fibrillation.

Conditions

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Cardiac Surgery Post-pericardiotomy Syndrome Atrial Fibrillation Pericardial Effusion Pleural Effusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo 48 to 72 hours before surgery till 1 months after surgery

Colchicine

Group Type ACTIVE_COMPARATOR

Colchicine

Intervention Type DRUG

Colchicine 0.5 mg BID or colchicine 0.5mg (\<70kg) 48 to 72 hours before surgery till 1 months after surgery

Interventions

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Colchicine

Colchicine 0.5 mg BID or colchicine 0.5mg (\<70kg) 48 to 72 hours before surgery till 1 months after surgery

Intervention Type DRUG

Placebo

Placebo 48 to 72 hours before surgery till 1 months after surgery

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age \> 18years
* Candidate to cardiac surgery but cardiac transplantation
* Informed consent

Exclusion Criteria

* Atrial fibrillation
* Candidate to cardiac transplantation
* Severe liver disease or elevation of serum transaminases (\> 1.5 times the upper reference limit)
* Serum creatinine \> 2.5 mg/dL
* Preoperative elevation of CK or known myopathy
* Known chronic intestinal diseases or blood dyscrasias
* Pregnancy, Lactation or Women of childbearing potential not protected by a contraception method
* Hypersensitivity to colchicine
* Treatment with colchicine for any cause

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No