drugset / Trial / NCT02706860

Efficacy of Different Perioperative Statin Regimens on the Protection Against Post Coronary Artery Bypass Grafting Major Adverse Cardio-cerebral Events

NCT02706860 ↗

Phase 4 Completed 94 enrolled Cairo University
RandomizedParallel-groupOpen-labelPrevention

Summary

This study aims at comparing different perioperative statin regimens for the prevention of post CABG adverse events. This was a randomized, prospective clinical trial. Ninety four patients scheduled for elective, isolated on- or off- pump CABG were randomly assigned to one of 3 treatment groups; 80 mg atorvastatin/day for 2 days preoperatively (N=37), 80 mg atorvastatin/day for 5-9 days preoperatively (N=28) or 40 mg atorvastatin/day for 5-9 days preoperatively (N=29). The corresponding preoperative doses were restarted postoperatively (post-op) when patients were able to take the medication orally and were continued for one month. Cardiac troponin I (TnI), Creatine Kinase (CK-MB) and C-reactive protein (CRP) were assayed preoperatively and post-operatively at 8, 24, 48 hours, and at discharge. Marker levels were compared among the three groups. The incidence of post-operative major adverse cardiac and cerebrovascular events (MACCE) was assessed including; 30-day all-cause mortality, myocardial infarction, atrial fibrillation, ventricular tachycardia/ventricular fibrillation, stroke and target-vessel revascularization. The incidence of renal or hepatic impairment and post-operative infections were also assessed. A Quality of life (QoL) questionnaire (EQ-5D-3L) was administered preoperatively and 1 month after CABG.

Timeline

Start
2013-06
Primary completion
2015-02
Completion
2015-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 40 mg Oral
Subject Atorvastatin Small molecule 80 mg Oral

Indications

No indication recorded.