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

March 27, 2019 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

290

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pravastatin group
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
Experimental: Combination of Atorvastatin and trimetazidine group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of the composite of death from any cause
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

April 8, 2018

Study Completion (Actual)

April 8, 2018

Study Registration Dates

First Submitted

May 15, 2013

First Submitted That Met QC Criteria

May 17, 2013

First Posted (Estimate)

May 20, 2013

Study Record Updates

Last Update Posted (Actual)

March 29, 2019

Last Update Submitted That Met QC Criteria

March 27, 2019

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2010-0511

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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