NCT01857921

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 290 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery

Interventions

Type	Name	Description
DRUG	Pravastatin 20mg/day for 12 months after randomization	Patients with mono antiplatelet therapy with aspirin who had had received CABG previously fulfilling all enrollment criteria will be randomly assigned to the type of two groups. Randomization of statin therapy will be done 1:1 to one of two different groups on the web-based program: 1. Test group: * Atorvastatin 40 mg and trimetazidine MR 70 mg daily for 12 months after randomization 2. Control group: * Pravastatin 20mg daily for 12 months after randomization
DRUG	Atorvastatin 40 mg and trimetazidine MR 70 mg/day for 12 months after randomization	Patients with mono antiplatelet therapy with aspirin who had had received CABG previously fulfilling all enrollment criteria will be randomly assigned to the type of two groups. Randomization of statin therapy will be done 1:1 to one of two different groups on the web-based program: 1. Test group: * Atorvastatin 40 mg and trimetazidine MR 70 mg daily for 12 months after randomization 2. Control group: * Pravastatin 20mg daily for 12 months after randomization

Timeline

• Start date: 2010-12-01
• Primary completion: 2018-04-08
• Completion: 2018-04-08
• First posted: 2013-05-20
• Last updated: 2019-03-29

Locations

1 site across 1 country: South Korea