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Cochicine Treatment for Post- Operative Pericardial Effusion

NCT01266694 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 199

Last updated 2014-01-14

No results posted yet for this study

Summary

Background: The incidence of asymptomatic pericardial effusion is high after cardiac surgery.

Objective: To assess whether colchicine is effective in reducing post operative pericardial effusion volume.

Design: Multicenter, randomized, double-blind, placebo-controlled study. Intervention : colchicine 1mg vs placebo, once daily for 14 days Setting :10 post operative cardiac rehabilitation centers. Patients: 200 patients at high risk of tamponade because of moderate to large persistent pericardial effusion (grade 2, 3 or 4 on a scale of 0 to 4 measured by echocardiography) more than 7 days after cardiac surgery.

Measurements: The main end point will be change in effusion grade after 14 days of treatment. Secondary endpoints include frequency of late cardiac tamponade.

Conditions

  • Pericardial Effusion

Interventions

DRUG

Colchicines

oral form, 1 mg, once a day during 14 days

DRUG

Placebo

oral form, placebo

Sponsors & Collaborators

  • French Federation of Cardiology

    collaborator OTHER

  • French Cardiology Society

    lead OTHER

Principal Investigators

  • Philippe Meurin, MD · Clinique Les Grands Près - Villeneuve Saint Denis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2013-03-31
Completion
2014-01-31

Countries

  • France

Study Locations

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Entities

Drugs

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 NCT01266694 on ClinicalTrials.gov