drugset / Trial / NCT01857921

Combination Effects of High-dose Statin and Trimetazidine on Patients With Aspirin Mono Antiplatelet Therapy 12-months After Coronary Artery Bypass Surgery

NCT01857921

Completed 290 enrolled Yonsei University
RandomizedParallel-groupOpen-labelTreatment

Summary

Trimetazidine is a metabolic agent without any negative inotropic or vasodilatory properties. In addition, previous reports showed that trimetazidine was effective in reducing intracoronary platelet aggregation and preventing platelet thrombogenesis. Therefore, for the evaluation of these combination effects of statin and trimetazidine on patients with aspirin monotherapy who had previously received CABG and were free of the major adverse cardiac events such as death, MI, TLR, or TVR for 12 months, the investigators hypothesize that atorvastatin 40mg/day would be more effective in the prevention of the further late adverse cardiac and cerebrovascular events than other statin. To test this hypothesis, the investigators will perform a multi-center, randomized, prospective trial aimed at demonstrating the superiority of combination of high dose atorvastatin therapy and trimetazidine to pravastatin in patients with aspirin monotherapy 12 months after CABG surgery in real world practice.

Timeline

Start
2010-12
Primary completion
2018-04-08
Completion
2018-04-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 40 mg
Comparator Pravastatin Small molecule 20 mg
Subject Trimetazidine Small molecule 70 mg