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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01857921
Recruitment Status : Completed
First Posted : May 20, 2013
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Drug: Pravastatin 20mg/day for 12 months after randomization Drug: Atorvastatin 40 mg and trimetazidine MR 70 mg/day for 12 months after randomization Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2010
Actual Primary Completion Date : April 8, 2018
Actual Study Completion Date : April 8, 2018

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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




Primary Outcome Measures :
  1. Occurrence of the composite of death from any cause [ Time Frame: 12 months ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857921


Locations
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Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01857921    
Other Study ID Numbers: 4-2010-0511
First Posted: May 20, 2013    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: December 2018
Additional relevant MeSH terms:
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Trimetazidine
Atorvastatin
Pravastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Vasodilator Agents