COlchicine for the preVention of postopErative atrial fibRillation in patients undergoing Coronary Artery By-pass Grafting
Completed
- Conditions
- Coronary Artery Disease ? Coronary Artery Surgery ? Atrial FibrillationCirculatory SystemAtherosclerotic heart disease
- Registration Number
- ISRCTN72835417
- Lead Sponsor
- Catholic University of the Sacred Heart-Rome (Italy)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 320
Inclusion Criteria
All the patients electively submitted to coronary artery by-pass grafting with arterial conduits and without contraindications to colchicine
Exclusion Criteria
1. Patients with preoperative atrial fibrillation
2. Known contraindication to Colchicine
3. Transaminases on admission more that 1.5 times the normal values
4. Creatinine clearance less than 30 ml/min
5. History of myopathy or elevated creatinine kinase
6. Hematologic disease
7. Gastrointestinal disease
8. Presence of systemic inflammatory or autoimmune disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Postoperative Atrial Fibrillation as defined by the 2010 ESC Guideline for the treatment of Atrial Fibrillation occurring at any time during the postoperative period . The arrhythmia may be detected by any of the following postoperative exams a) ECG monitoring in the ICU; b) 48 hrs Holter ECG thereafter ; c) 12 Leads ECG twice a day until hospital discharge
- Secondary Outcome Measures
Name Time Method Occurrence of any atrial arrhythmia <br>Occurrence of any arrhythmia necessitating drug suspension<br>Occurrence of any complication or major side effect of Colchicine