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

NCT ID: NCT01857921

Last Updated: 2019-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 290 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2018-04-08

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pravastatin group

Group Type: ACTIVE_COMPARATOR

Pravastatin 20mg/day for 12 months after randomization

Intervention Type: DRUG

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

Combination of Atorvastatin and trimetazidine group

Group Type: EXPERIMENTAL

Atorvastatin 40 mg and trimetazidine MR 70 mg/day for 12 months after randomization

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients who had previously received CABG 12 months ago
• Patients who were free of death, MI or repeat revascularization within first 12 months after CABG
• Patients with mono antiplatelet therapy with aspirin alone
• Age of 20 years or older
• Patients with signed informed consent

Exclusion Criteria

• History of DES or BMS implantation within 12 months
• Patients who required the continuing dual antiplatelet therapy or additional other types of antithrombotics or antiplatelets such as cilostazol or ticlopidine, etc besides aspirin after DES implantation
• Patients who could not be prescribed aspirin or statins due to contraindication or severe side effects
• Pregnant women or women with potential childbearing
• Life expectancy ≤ 2 year

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4-2010-0511

Identifier Type: -

Identifier Source: org_study_id