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OpenTrials
Completed

NCT Number: NCT01857921

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

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.

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Key information

Conditions

Coronary Artery

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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:

  • Test group:
  • Atorvastatin 40 mg and trimetazidine MR 70 mg daily for 12 months after randomization
  • Control group:
  • Pravastatin 20mg daily for 12 months after randomization

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:

  • Test group:
  • Atorvastatin 40 mg and trimetazidine MR 70 mg daily for 12 months after randomization
  • Control group:
  • Pravastatin 20mg daily for 12 months after randomization

Primary outcomes

  1. Occurrence of the composite of death from any cause

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2010
Primary completion
2018
Study completion
2018
First posted
May 20, 2013
Registry last updated
Mar 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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