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

Atrial Fibrillation Clinical Trial

— COPPS-2  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01552187
• Other study ID #: 86/19/11
• Secondary ID: 2011-005835-21
• Status: Active, not recruiting
• Phase: Phase 3
• First received: March 6, 2012
• Last updated: June 29, 2014
• Start date: March 2012
• Est. completion date: July 2014

Study information

• Verified date: June 2014
• Source: Maria Vittoria Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 360
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Italy	Cardiology Dpt. Maria Vittoria Hospital	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Maria Vittoria Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-pericardiotomy syndrome, post-operative effusions, post-operative atrial fibrillation incidence	Incidence of the outcomes at 3 months from cardiac surgery	3 months	No
Secondary	Cardiac Tamponade or Need for Pericardiocentesis		3 months	No
Secondary	Need for thoracentesis		3 months	No
Secondary	Recurrence of the post-pericardiotomy syndrome		3 months	No
Secondary	Re-admission		3 months	No
Secondary	Overall mortality		3 months	No
Secondary	Stroke incidence		3 months	No