NCT01552187

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 1, 2014

Status Verified

June 1, 2014

Enrollment Period

2.3 years

First QC Date

March 6, 2012

Last Update Submit

June 29, 2014

Conditions

Cardiac SurgeryPost-pericardiotomy SyndromeAtrial FibrillationPericardial EffusionPleural Effusion

Keywords

cardiac surgerypost-pericardiotomy syndromeatrial fibrillationpericardial effusionpleural effusionpreventioncolchicine

Outcome Measures

Primary Outcomes (1)

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

    Incidence of the outcomes at 3 months from cardiac surgery

    3 months

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Colchicine

ACTIVE COMPARATOR

Colchicine

Drug: Colchicine

Interventions

ColchicineDRUG

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

Colchicine
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology Dpt. Maria Vittoria Hospital

Torino, Torino, 10141, Italy

Location

Related Publications (2)

  • 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.

    PMID: 25172965DERIVED

  • 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.

    PMID: 23816016DERIVED

MeSH Terms

Conditions

Postpericardiotomy SyndromeAtrial FibrillationPericardial EffusionPleural Effusion

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsArrhythmias, CardiacPleural DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 6, 2012

First Posted

March 13, 2012

Study Start

March 1, 2012

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

July 1, 2014

Record last verified: 2014-06

Locations

IT(1)