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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01552187
Other study ID # 86/19/11
Secondary ID 2011-005835-21
Status Active, not recruiting
Phase Phase 3
First received March 6, 2012
Last updated June 29, 2014
Start date March 2012
Est. completion date July 2014

Study information

Verified date June 2014
Source Maria Vittoria Hospital
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 360
Est. completion date July 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Intervention

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

Locations

Country Name City State
Italy Cardiology Dpt. Maria Vittoria Hospital Torino

Sponsors (1)

Lead Sponsor Collaborator
Maria Vittoria Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post-pericardiotomy syndrome, post-operative effusions, post-operative atrial fibrillation incidence Incidence of the outcomes at 3 months from cardiac surgery 3 months No
Secondary Cardiac Tamponade or Need for Pericardiocentesis 3 months No
Secondary Need for thoracentesis 3 months No
Secondary Recurrence of the post-pericardiotomy syndrome 3 months No
Secondary Re-admission 3 months No
Secondary Overall mortality 3 months No
Secondary Stroke incidence 3 months No
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