Trial Review

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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
Date results information 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.
Scientific title
Effect of Trimetazidine on clinical events after primary percutaneous coronary intervention in patients with ST-elevation myocardial infarction.
Secondary ID [1] 298919 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischemic heart disease 313900 0
ST-elevation myocardial infarction 313901 0
Condition category
Condition code
Cardiovascular 312313 312313 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 315200 0
Treatment: Drugs
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
Control group
Active

Outcomes
Primary outcome [1] 320946 0
Readmission due cardiac event within 6 months after the initial discharge.This outcomes assessed by using medical records
Timepoint [1] 320946 0
6 month post dose
Primary outcome [2] 320947 0
Comparison of left ventricular ejection fraction after six month. Patients underwent echocardiography after 3 and 6 months
Timepoint [2] 320947 0
6 month post dose
Secondary outcome [1] 373460 0
Recurrent ischemia. This outcome was assessed using medical records, clinical examination and ECG
Timepoint [1] 373460 0
6 month post dose
Patients underwent clinical examination and ECG after 3 and 6 months
Secondary outcome [2] 373461 0
Worsening heart failure. This outcome was assessed using medical records, clinical examination.
Timepoint [2] 373461 0
6 month post dose
Patients underwent clinical examination after 3 and 6 months. Medical records were collected after 3 and 6 months
Secondary outcome [3] 373462 0
Other heart-related complications, such as arrhythmias, hypertensive crisis. This outcome was assessed using medical records, clinical examination and ECG.
Timepoint [3] 373462 0
6 month post dose
Medical records were collected after 3 and 6 months. Patients underwent clinical examination after 3 and 6 months.

Eligibility
Key inclusion criteria
ST-elevation myocardial infarction
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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,

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
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).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2016
Date of last participant enrolment
Anticipated
Actual
1/04/2016
Date of last data collection
Anticipated
Actual
1/10/2016
Sample size
Target
706
Accrual to date
Final
680
Recruitment outside Australia
Country [1] 21740 0
Armenia
State/province [1] 21740 0
Yerevan

Funding & Sponsors
Funding source category [1] 303465 0
Self funded/Unfunded
Name [1] 303465 0
none
Country [1] 303465 0
Primary sponsor type
Individual
Name
Hamlet Hayrapetyan, FESC
Address
Erebouni medical center
Armenia, Yerevan, Titogradyan street, 14
Country
Armenia
Secondary sponsor category [1] 303520 0
None
Name [1] 303520 0
none
Address [1] 303520 0
none
Country [1] 303520 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303996 0
Ethic Committee of Erebouni Medical Center
Ethics committee address [1] 303996 0
Armenia, Yerevan, Titigradyan street, 14
Ethics committee country [1] 303996 0
Armenia
Date submitted for ethics approval [1] 303996 0
15/01/2015
Approval date [1] 303996 0
05/02/2015
Ethics approval number [1] 303996 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95494 0
Prof Hamlet Hayrapetyan
Address 95494 0
Erebouni Medical Center ,Yerevan, Titogradyan street, 0087
Country 95494 0
Armenia
Phone 95494 0
+37491505005
Fax 95494 0
Email 95494 0
cardioerebouni@yahoo.com
Contact person for public queries
Name 95495 0
Harutyun Petrosyan
Address 95495 0
Erebouni Medical Center ,Yerevan, Titogradyan street, 0087
Country 95495 0
Armenia
Phone 95495 0
+37455280706
Fax 95495 0
Email 95495 0
haroot.petrosyan@gmail.com
Contact person for scientific queries
Name 95496 0
Hamlet Hayrapetyan
Address 95496 0
Erebouni Medical Center ,Yerevan, Titogradyan street, 0087
Country 95496 0
Armenia
Phone 95496 0
+37491505005
Fax 95496 0
Email 95496 0
cardioerebouni@yahoo.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.