Trial Review

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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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000405415
Ethics application status
Approved
Date submitted
6/02/2025
Date registered
5/05/2025
Date last updated
5/05/2025
Date data sharing statement initially provided
5/05/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Dapagliflozin on Heart Failure Risk in Non-Diabetic Patients with Acute Heart Attack
Scientific title
Efficacy and Safety of Dapagliflozin in Non-Diabetic Patients with Primary Anterior ST-Elevation Myocardial Infarction Initiated in the Early Hospital Period: A Randomized Controlled Study
Secondary ID [1] 313895 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary anterior ST-elevation myocardial infarction (STEMI) 336577 0
Condition category
Condition code
Cardiovascular 333088 333088 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This interventional study evaluates the effects of Dapagliflozin in non-diabetic patients with primary anterior ST-elevation myocardial infarction (STEMI).
Intervention Group (Dapa group): Patients receive Dapagliflozin 10 mg once daily, administered as an oral tablet, initiated within the first 48 hours of hospital admission. The intervention is continued for one year. Adherence is monitored through regular follow-up visits. To evaluate the effects of the intervention, echocardiographic assessments and NT-proBNP measurements are conducted at baseline and at the end of the one-year follow-up period.
Intervention code [1] 330482 0
Treatment: Drugs
Comparator / control treatment
The control group receives standard medical therapy for primary anterior ST-elevation myocardial infarction (STEMI), which includes:

Beta-blockers
Angiotensin-converting enzyme (ACE) inhibitors
Other guideline-directed medical therapy as needed
Unlike the intervention group, the control group does not receive Dapagliflozin. Patients in both groups are followed for one year to assess outcomes.
Control group
Active

Outcomes
Primary outcome [1] 340621 0
One-year heart failure hospitalizations
Timepoint [1] 340621 0
Baseline (initial hospitalization) One year after randomization
Secondary outcome [1] 444627 0
One-year cardiovascular mortality
Timepoint [1] 444627 0
One year after randomization

Eligibility
Key inclusion criteria
Age: Adults between 18 and 80 years old, inclusive
Diagnosis: Confirmed primary anterior ST-elevation myocardial infarction (STEMI)
Time Frame: Symptom onset within 24 hours before hospital admission
Intervention Timing: Underwent primary percutaneous coronary intervention (PCI)
Left Ventricular Function: Left ventricular ejection fraction of 45% or less
Biomarker Criteria: NT-proBNP concentration greater than 900 pg/ml at admission
Diabetes Status: No history of diabetes mellitus (Non-diabetic patients only)
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cardiogenic shock
History of diabetes mellitus (to ensure study only includes non-diabetic patients)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
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
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Continuous variables are expressed as the mean ± standard deviation (SD), and categorical variables are summarized as counts (frequency) and group percentages. 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% confidence intervals (CI) for readmission rates in TMZ versus CTL-treated patients were calculated using binomial logistic regression models to account for the individual prognostic importance of the research parameters. All calculated p values were two-tailed and considered 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
1/12/2021
Date of last participant enrolment
Anticipated
Actual
1/02/2024
Date of last data collection
Anticipated
Actual
30/12/2024
Sample size
Target
124
Accrual to date
Final
124
Recruitment outside Australia
Country [1] 26865 0
Armenia
State/province [1] 26865 0
Erevan

Funding & Sponsors
Funding source category [1] 318362 0
Self funded/Unfunded
Name [1] 318362 0
Country [1] 318362 0
Primary sponsor type
Hospital
Name
Erebouni Medical Center
Address
Country
Armenia
Secondary sponsor category [1] 320765 0
None
Name [1] 320765 0
Address [1] 320765 0
Country [1] 320765 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316995 0
Erebouni MC ethics commitee
Ethics committee address [1] 316995 0
Ethics committee country [1] 316995 0
Armenia
Date submitted for ethics approval [1] 316995 0
01/10/2021
Approval date [1] 316995 0
04/11/2021
Ethics approval number [1] 316995 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139690 0
Prof Hamlet Hayrapetyan
Address 139690 0
EREBOUNI MC, 14 Titogradyan Yerevan-0087 Armenia,
Country 139690 0
Armenia
Phone 139690 0
+374 091505005
Fax 139690 0
Email 139690 0
[email protected]
Contact person for public queries
Name 139691 0
Hamlet Hayrapetyan
Address 139691 0
EREBOUNI MC, 14 Titogradyan Yerevan-0087 Armenia,
Country 139691 0
Armenia
Phone 139691 0
+374 010 471100
Fax 139691 0
Email 139691 0
[email protected]
Contact person for scientific queries
Name 139692 0
Hamlet Hayrapetyan
Address 139692 0
EREBOUNI MC, 14 Titogradyan Yerevan-0087 Armenia,
Country 139692 0
Armenia
Phone 139692 0
+374 091505005
Fax 139692 0
Email 139692 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: The individual participant data (IPD) will not be made available due to concerns regarding patient confidentiality and privacy.



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.