drugset / Trial / NCT00953212

Prophylaxis to Reduce Postoperative Atrial Fibrillation in Cardiac Surgery

NCT00953212

Phase 3 Completed 304 enrolled MaineHealth
RandomizedFactorialDouble-blindPrevention

Summary

Atrial Fibrillation (AF) is a common postoperative complication of cardiac surgery, occuring in approximately 25-30% of coronary artery bypass graft (CABG) patients and 35-40% of heart valve repair/replacement patients. Efforts to decrease the high rates of AF have not made great inroads to the problem. The current standard of care is the use of preoperative and postoperative beta blockers. We propose to compare the use of prophylactic oral ascorbic acid with and without prophylactic oral amiodarone, in combination with oral beta blockers, for the prevention of atrial fibrillation after open heart surgery. The hypothesis is that either drug, or a combination of the two drugs, will be superior and safe when compared to beta blockers alone.

Timeline

Start
2009-08
Primary completion
2012-01
Completion
2012-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amiodarone Small molecule 400 mg Oral
Comparator Vitamin C Other / unclassified 1000 mg Oral
Comparator Metoprolol Other / unclassified 25 mg Oral