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Trial registered on ANZCTR
Registration number
ACTRN12619001616167
Ethics application status
Approved
Date submitted
4/08/2019
Date registered
22/11/2019
Date last updated
22/11/2019
Date data sharing statement initially provided
22/11/2019
Type of registration
Retrospectively registered
Titles & IDs
Public title
Effect of Trimetazidine on clinical events after primary percutaneous coronary intervention in patients with ST-elevation myocardial infarction.
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Scientific title
Effect of Trimetazidine on clinical events after primary percutaneous coronary intervention in patients with ST-elevation myocardial infarction.
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Secondary ID [1]
298919
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ischemic heart disease
313900
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ST-elevation myocardial infarction
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Condition category
Condition code
Cardiovascular
312313
312313
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0
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Coronary heart disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Trimetazidine 35 mg oral tablet, twice per day, 6 month
Every two out of three STEMI patients received medication.
Every third patient on a medical attendance list was not offered to receiving medication ''Trimetazidine", thus the ratio of patients in groups is approximately 2: 1
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Intervention code [1]
315200
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Treatment: Drugs
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Comparator / control treatment
The aim of this multicenter prospective study is to compare the long-
term (6-month) effect of Trimetazidine with standart care on post-discharge outcomes after primary percutaneous coronary intervention in patients with primary ST-elevation myocardial infarction. Standard care is mean that patients underwent to treatment according to ESC guidelines of STEMI.One group received treatment only according to ESC guidelines of STEMI and another group received treatment according to ESC guidelines + trimetazidine
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Control group
Active
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Outcomes
Primary outcome [1]
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Readmission due cardiac event within 6 months after the initial discharge.This outcomes assessed by using medical records
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Assessment method [1]
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Timepoint [1]
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6 month post dose
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Primary outcome [2]
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Comparison of left ventricular ejection fraction after six month. Patients underwent echocardiography after 3 and 6 months
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Assessment method [2]
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Timepoint [2]
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6 month post dose
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Secondary outcome [1]
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Recurrent ischemia. This outcome was assessed using medical records, clinical examination and ECG
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Assessment method [1]
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Timepoint [1]
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6 month post dose
Patients underwent clinical examination and ECG after 3 and 6 months
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Secondary outcome [2]
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Worsening heart failure. This outcome was assessed using medical records, clinical examination.
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Assessment method [2]
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Timepoint [2]
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6 month post dose
Patients underwent clinical examination after 3 and 6 months. Medical records were collected after 3 and 6 months
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Secondary outcome [3]
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Other heart-related complications, such as arrhythmias, hypertensive crisis. This outcome was assessed using medical records, clinical examination and ECG.
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Assessment method [3]
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Timepoint [3]
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6 month post dose
Medical records were collected after 3 and 6 months. Patients underwent clinical examination after 3 and 6 months.
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Eligibility
Key inclusion criteria
ST-elevation myocardial infarction
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
previous or recurrent acute myocardial infarction, heart valve disease, acute cerebrovascular or vessel disease, serious renal or live failure, oncologic disease or any other non-cardiologic serious medical condition with a life expectancy of less than 1 year,
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Continuous variables are expressed as mean ± standard deviation (SD) and categorical
variables are summarized as count (frequency) and group percentage. Differences in mean
values of parametric continuous variables between groups were assessed using the paired or unpaired Student’s t-test when appropriate. Categorical variables between groups were
compared using Pearson Chi-square test and calculating odds ratios (OR) with 95%
confidence intervals (CI). Adjusted odds ratios (OR adj ) with 95% CI for readmission rates in TMZ versus CTL treated patients were calculated in binomial logistic regression models to account for individual prognostic importance of the research parameters. All calculated p values were two-tailed and considered as statistically significant when <0.05. Statistical tests were derived from SPSS version 22.0 software (SPSS, Inc., Chicago, IL, USA).
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
1/01/2016
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Date of last participant enrolment
Anticipated
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Actual
1/04/2016
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Date of last data collection
Anticipated
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Actual
1/10/2016
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Sample size
Target
706
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Accrual to date
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Final
680
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Recruitment outside Australia
Country [1]
21740
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Armenia
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State/province [1]
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Yerevan
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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none
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Address [1]
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none
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Country [1]
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Primary sponsor type
Individual
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Name
Hamlet Hayrapetyan, FESC
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Address
Erebouni medical center
Armenia, Yerevan, Titogradyan street, 14
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Country
Armenia
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Secondary sponsor category [1]
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None
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Name [1]
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none
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Address [1]
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none
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Country [1]
303520
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Ethic Committee of Erebouni Medical Center
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Ethics committee address [1]
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Armenia, Yerevan, Titigradyan street, 14
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Ethics committee country [1]
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Armenia
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Date submitted for ethics approval [1]
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15/01/2015
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Approval date [1]
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05/02/2015
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Ethics approval number [1]
303996
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Summary
Brief summary
Trimetazidine (TMZ) is considered by most researchers as an anti-ischemic agent with anti-oxidant activity. The aim of this multicenter prospective study is to evaluate the long-term (6-month) effect of TMZ on post-discharge outcomes after primary percutaneous coronary intervention (PCI) in patients with primary ST-elevation myocardial infarction (STEMI).We compared left ventricular ejection fraction (LVEF) and cardiac readmission rates including those of recurrent ischemia due to restenosis in the TMZ and control groups at the end of 3 rd and 6 th months.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Hamlet Hayrapetyan
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Address
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Erebouni Medical Center ,Yerevan, Titogradyan street, 0087
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Country
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Armenia
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Phone
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+37491505005
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Harutyun Petrosyan
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Address
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Erebouni Medical Center ,Yerevan, Titogradyan street, 0087
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Country
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Armenia
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Phone
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+37455280706
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Hamlet Hayrapetyan
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Address
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Erebouni Medical Center ,Yerevan, Titogradyan street, 0087
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Country
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Armenia
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Phone
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+37491505005
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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