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

Maria Vittoria Hospital360 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

360

Conditions

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

Interventions

ColchicineDRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Cardiology Dpt. Maria Vittoria Hospital

Torino, Torino, Italy

Outcomes

Primary Outcomes

Post-pericardiotomy syndrome, post-operative effusions, post-operative atrial fibrillation incidence

Incidence of the outcomes at 3 months from cardiac surgery

Time frame: 3 months

Secondary Outcomes

Cardiac Tamponade or Need for Pericardiocentesis

Time frame: 3 months

Need for thoracentesis

Time frame: 3 months

Recurrence of the post-pericardiotomy syndrome

Time frame: 3 months

Re-admission

Time frame: 3 months

Overall mortality

Time frame: 3 months

Stroke incidence

Time frame: 3 months

Data from ClinicalTrials.gov

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