NCT00128427

Brief Summary

The purpose of the study is to determine whether colchicine is safe and effective in the prevention of the postpericardiotomy syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2005

Longer than P75 for phase_3

Geographic Reach
1 country

6 active sites

Status
completed

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

June 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2005

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

June 15, 2010

Status Verified

June 1, 2010

Enrollment Period

5 years

First QC Date

August 8, 2005

Last Update Submit

June 13, 2010

Conditions

Postpericardiotomy Syndrome

Keywords

Postpericardiotomy SyndromePericarditisPreventionColchicineRecurrence

Outcome Measures

Primary Outcomes (1)

  • Postpericardiotomy syndrome

    12 months

Secondary Outcomes (1)

  • Disease-related hospitalization, cardiac tamponade, constrictive pericarditis and relapses

Interventions

Colchicine (for 1 month)DRUG

Eligibility Criteria

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

You may qualify if:

  • Patients in the third day after a cardiac surgery operation
  • Age≥ 18 years
  • Informed consent

You may not qualify if:

  • All evaluated before the surgical operation:
  • Known severe liver disease and/or elevated transaminases \>1.5 times the upper limit of normality
  • Serum creatinine \>2.5 mg/dl
  • Serum creatine kinase (CK) over the upper limit of normality or known myopathy
  • Known gastrointestinal or blood disease
  • Pregnant or lactating women or women not protected by a contraception method
  • Known hypersensibility to colchicine
  • Treatment with colchicine at enrolment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Ospedali Riuniti

Bergamo, Bergamo, Italy

Location

Ospedale Regionale Bolzano

Bolzano, Bolzano, Italy

Location

Ospedale Niguarda

Milan, Milano, Italy

Location

Cardiology Department. Maria Vittoria Hospital. ASL 3. Torino.

Torino, Torino, 10141, Italy

Location

Cardiac Surgery- Ospedale Mauriziano

Torino, Torino, Italy

Location

Ospedale di Rivoli

Rivoli, Italy

Location

Related Publications (3)

  • Imazio M, Brucato A, Ferrazzi P, Rovere ME, Gandino A, Cemin R, Ferrua S, Belli R, Maestroni S, Simon C, Zingarelli E, Barosi A, Sansone F, Patrini D, Vitali E, Trinchero R, Spodick DH, Adler Y; COPPS Investigators. Colchicine reduces postoperative atrial fibrillation: results of the Colchicine for the Prevention of the Postpericardiotomy Syndrome (COPPS) atrial fibrillation substudy. Circulation. 2011 Nov 22;124(21):2290-5. doi: 10.1161/CIRCULATIONAHA.111.026153. Epub 2011 Nov 16.

    PMID: 22090167DERIVED

  • Imazio M, Brucato A, Rovere ME, Gandino A, Cemin R, Ferrua S, Maestroni S, Zingarelli E, Barosi A, Simon C, Sansone F, Patrini D, Vitali E, Belli R, Ferrazzi P, Trinchero R, Spodick DH, Adler Y. Colchicine prevents early postoperative pericardial and pleural effusions. Am Heart J. 2011 Sep;162(3):527-32.e1. doi: 10.1016/j.ahj.2011.05.017. Epub 2011 Jul 18.

    PMID: 21884871DERIVED

  • Imazio M, Trinchero R, Brucato A, Rovere ME, Gandino A, Cemin R, Ferrua S, Maestroni S, Zingarelli E, Barosi A, Simon C, Sansone F, Patrini D, Vitali E, Ferrazzi P, Spodick DH, Adler Y; COPPS Investigators. COlchicine for the Prevention of the Post-pericardiotomy Syndrome (COPPS): a multicentre, randomized, double-blind, placebo-controlled trial. Eur Heart J. 2010 Nov;31(22):2749-54. doi: 10.1093/eurheartj/ehq319. Epub 2010 Aug 30.

    PMID: 20805112DERIVED

MeSH Terms

Conditions

Postpericardiotomy SyndromePericarditisRecurrence

Interventions

ColchicineWW Domain-Containing Oxidoreductase

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic CompoundsShort Chain Dehydrogenase-ReductasesNAD (+) and NADP (+) Dependent Alcohol OxidoreductasesAlcohol OxidoreductasesOxidoreductasesEnzymesEnzymes and CoenzymesTumor Suppressor ProteinsNeoplasm ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Rita TRINCHERO, MD

    Cardiology Department. Maria Vittoria Hospital. ASL 3. Torino.

    STUDY CHAIR

  • Massimo IMAZIO, MD

    Cardiology Department. Maria Vittoria Hospital. ASL 3. Torino.

    STUDY CHAIR

  • Massimo IMAZIO, MD

    Cardiology Department. Maria Vittoria Hospital. ASL 3. Torino.

    PRINCIPAL INVESTIGATOR

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

Study Record Dates

First Submitted

August 8, 2005

First Posted

August 10, 2005

Study Start

June 1, 2005

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

June 15, 2010

Record last verified: 2010-06

Locations

IT(6)