Coronary ArteryNCT01857921
Combination Effects of High-dose Statin and Trimetazidine on Patients With Aspirin Mono Antiplatelet Therapy 12-months After Coronary Artery Bypass Surgery
A study testing Pravastatin 20mg/day for 12 months after randomization and Atorvastatin 40 mg and trimetazidine MR 70 mg/day for 12 months after randomization in people with Coronary Artery, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Coronary Artery
- What is being tested?
- Pravastatin 20mg/day for 12 months after randomization and Atorvastatin 40 mg and trimetazidine MR 70 mg/day for 12 months after randomization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2010to 8 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Pravastatin 20mg/day for 12 months after randomization, Atorvastatin 40 mg and trimetazidine MR 70 mg/day for 12 months after randomization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pravastatin 20mg/day for 12 months after randomizationDrug
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 randomizationDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Pravastatin group | Active comparator | Not described Receives: Drug: Pravastatin 20mg/day for 12 months after randomization |
| Combination of Atorvastatin and trimetazidine group | Experimental | Not described Receives: Drug: Atorvastatin 40 mg and trimetazidine MR 70 mg/day for 12 months after randomization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of the composite of death from any cause
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startDec 2010
- Primary completion8 Apr 2018
- Study completion8 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary ArteryStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857921
- Sponsor's protocol ID
- 4-2010-0511
- Status last verified
- Dec 2018
- First submitted
- 15 May 2013
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Effects of High-dose Statin and Trimetazidine on Patients With Aspirin Mono Antiplatelet Therapy 12-months After Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT01857921
- Acronym / sponsor ID
- 4-2010-0511
- Conditions
- Coronary Artery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- 8 Apr 2018 (actual)
- Study completion
- 8 Apr 2018 (actual)
- First posted
- 20 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pravastatin 20mg/day for 12 months after randomizationPatients 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 | Drug | Pravastatin group |
| Atorvastatin 40 mg and trimetazidine MR 70 mg/day for 12 months after randomizationPatients 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 | Drug | Combination of Atorvastatin and trimetazidine group |
Primary outcome
Occurrence of the composite of death from any cause
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pravastatin 20mg/day for 12 months after randomization and Atorvastatin 40 mg and trimetazidine MR 70 mg/day for 12 months after randomization in people with Coronary Artery, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of the composite of death from any cause (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2019.