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

NCT01552187 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2014-07-01

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Colchicine

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Maria Vittoria Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2014-06-30
Completion
2014-07-31

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01552187 on ClinicalTrials.gov