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

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

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation; Cardiac Surgery; Pleural Effusion; Pericardial Effusion; Post-pericardiotomy Syndrome
• Intervention / Treatment: Drug: Placebo; Drug: Colchicine

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 360
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Torino, Italy, 10141
    • Cardiology Dpt. Maria Vittoria Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Placebo 48 to 72 hours before surgery till 1 months after surgery
ACTIVE_COMPARATOR: Colchicine	Drug: Colchicine; Colchicine 0.5 mg BID or colchicine 0.5mg (<70kg) 48 to 72 hours before surgery till 1 months after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-pericardiotomy syndrome, post-operative effusions, post-operative atrial fibrillation incidence	Incidence of the outcomes at 3 months from cardiac surgery	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Cardiac Tamponade or Need for Pericardiocentesis	3 months
Need for thoracentesis	3 months
Recurrence of the post-pericardiotomy syndrome	3 months
Re-admission	3 months
Overall mortality	3 months
Stroke incidence	3 months

Collaborators and Investigators

• Sponsor: Maria Vittoria Hospital

Publications and helpful links

General Publications

• Imazio M, Brucato A, Ferrazzi P, Pullara A, Adler Y, Barosi A, Caforio AL, Cemin R, Chirillo F, Comoglio C, Cugola D, Cumetti D, Dyrda O, Ferrua S, Finkelstein Y, Flocco R, Gandino A, Hoit B, Innocente F, Maestroni S, Musumeci F, Oh J, Pergolini A, Polizzi V, Ristic A, Simon C, Spodick DH, Tarzia V, Trimboli S, Valenti A, Belli R, Gaita F; COPPS-2 Investigators. Colchicine for prevention of postpericardiotomy syndrome and postoperative atrial fibrillation: the COPPS-2 randomized clinical trial. JAMA. 2014 Sep 10;312(10):1016-23. doi: 10.1001/jama.2014.11026.
• Imazio M, Belli R, Brucato A, Ferrazzi P, Patrini D, Martinelli L, Polizzi V, Cemin R, Leggieri A, Caforio AL, Finkelstein Y, Hoit B, Maisch B, Mayosi BM, Oh JK, Ristic AD, Seferovic P, Spodick DH, Adler Y. Rationale and design of the COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 trial): a randomized, placebo-controlled, multicenter study on the use of colchicine for the primary prevention of the postpericardiotomy syndrome, postoperative effusions, and postoperative atrial fibrillation. Am Heart J. 2013 Jul;166(1):13-9. doi: 10.1016/j.ahj.2013.03.025. Epub 2013 May 6.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ANTICIPATED): June 1, 2014
• Study Completion (ANTICIPATED): July 1, 2014

Study Registration Dates

• First Submitted: March 6, 2012
• First Submitted That Met QC Criteria: March 8, 2012
• First Posted (ESTIMATE): March 13, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 1, 2014
• Last Update Submitted That Met QC Criteria: June 29, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: cardiac surgery; atrial fibrillation; prevention; pleural effusion; colchicine; pericardial effusion; post-pericardiotomy syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Postoperative Complications; Disease; Pleural Diseases; Arrhythmias, Cardiac; Syndrome; Atrial Fibrillation; Pleural Effusion; Pericardial Effusion; Postpericardiotomy Syndrome; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Gout Suppressants; Colchicine
• Other Study ID Numbers: 86/19/11; 2011-005835-21 (EUDRACT_NUMBER)