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

NCT01857921 | Completed

• 1 other identifier: 4-2010-0511
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Occurrence of the composite of death from any cause

  12 months

Study Arms (2)

Pravastatin group

ACTIVE COMPARATOR

Drug: Pravastatin 20mg/day for 12 months after randomization

Combination of Atorvastatin and trimetazidine group

EXPERIMENTAL

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

Interventions

Pravastatin 20mg/day for 12 months after randomization 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

Pravastatin group

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

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Interventions

Pravastatin; Atorvastatin

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2013
• First Posted: May 20, 2013
• Study Start: December 1, 2010
• Primary Completion: April 8, 2018
• Study Completion: April 8, 2018
• Last Updated: March 29, 2019

Record last verified: 2018-12

Locations

KR (1)