Atrial fibrillation, Chronic ischemic heart disease
Conditions
Interventions
Control group: 69 patients undergoing coronary artery bypass surgery remained untreated. Experimental group: 71 patients undergoing coronary artery bypass surgery were treated with colchicine prescrib
Drug
Sponsors
Hospital Santa Casa de Misericórdia de Curitiba
Hospital Santa Casa de Misericórdia de Curitiba
Eligibility
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Patients were recruited willing and able to provide informed consent and in accordance with the study procedures. All aged greater than or equal to 18 years; indication for elective coronary artery bypass grafting; sinus rhythm on the day preceding surgery. The mean age was 60.3 ± 8.1 years in the control group and 61.5 ± 10.3 years in the colchicine group (p = 0.44), 45 participants were female and 95 male. The sample size was 140 patients
Exclusion criteria
Exclusion criteria: Exclusion criteria were: contraindication for use of study medication; atrial fibrillation or atrial flutter previously diagnosed; need for associated valve surgery; severe liver disease (transaminases above 1.5 times normal); renal failure (creatinine> 2 mg / dl); gastrointestinal diseases known; current treatment with colchicine; cardiogenic shock; severe arrhythmias; neoplasms; patients not communicative; Simultaneous use of antiarrhythmic drugs, excluding digoxin, beta-blockers and calcium channel blockers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study endpoint was the rate of atrial fibrillation in the postoperative period of myocardial revascularization. For the current study, the 140 patients, 69 in the control group and 71 in the intervention group were needed to detect an FA rate of 20% and 6% (control and colchicine), with a power of 80% and using p = 0.05 in the two treatment groups. The determination of the estimated rates of FA for the two groups were based on the results of a placebo-controlled randomized study in which the FA rate was significantly lower in the colchicine group compared to the placebo group (12% versus 22%, respectively, p = 0.021);The patients in the colchicine group showed no reduction in the incidence of atrial fibrillation compared to the control group (13.04% versus 7.04%, control and colchicine, respectively; p = 0.271) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected | — |
Countries
Brazil
Contacts
Public ContactCamila Zarpelon
Hospital Santa Casa de Misericórdia de Curitiba
Outcome results
None listed