Protocol summary
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Study aim
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Effects of dapagliflozin in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention
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Design
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A controlled, parallel-group, double-blind, randomized, phase 3 clinical trial on 100 patients. Randomization was performed using permuted block randomization method.
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Settings and conduct
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This is a double-blind randomized clinical trial on 100 patients with ST elevation myocardial infarction undergoing primary percutaneous coronary intervention at Tabriz Shahid Madani Hospital. Patients in the intervention and control groups will receive dapagliflozin and placebo for 40 days. Patients will be compared regarding ST resolution, cardiac troponin I, high-sensitivity C-reactive protein level, ejection fraction, and major adverse cardiac events. Patients and researchers will not know about the assignment of patients to the intervention and placebo groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: STelevation myocardial infarction patients undergoing primary percutaneous coronary intervention, Ages 18-80 years, ability to understand and sign the consent form. Exclusion criteria: Pregnancy, Breastfeeding, Kidney failure (estimated glomerular filtration rate less than 30 ml/min), Liver failure, Systolic blood pressure below 100 mmHg, Inflammatory and autoimmune diseases, Diabetes mellitus, Chronic heart failure, Malignancy, Psychiatric disorders, Dapagliflozin contraindications, History of dapagliflozin use and myocardial infarction, symptoms onset more than 6 hours.
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Intervention groups
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The intervention group:patients will receive oral dapagliflozin of Modva Pharmaceuticals 10 mg/day for 40 days. The control group:patients will receive placebo of Modva Pharmaceuticals for 40 days plus standard treatments.
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Main outcome variables
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ST-segment resolution, Cardiac troponin I, hs-CRP, Ejection fraction, Major adverse cardiac events
General information
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Reason for update
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Adding the abbreviated name of the trial
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Acronym
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DAPA-STEMI
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IRCT registration information
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IRCT registration number:
IRCT20111206008307N44
Registration date:
2023-06-03, 1402/03/13
Registration timing:
prospective
Last update:
2024-01-08, 1402/10/18
Update count:
1
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Registration date
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2023-06-03, 1402/03/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-06-22, 1402/04/01
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Expected recruitment end date
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2023-08-23, 1402/06/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Dapagliflozin effects in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: a randomized clinical trial
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Public title
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Dapagliflozin effects in patients with myocardial infarction
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention
Patients aged between 18 to 80 years
Consented patients
Exclusion criteria:
Pregnancy
Lactation
Renal failure (estimated glomerular filtration rate less than 30 ml/min)
Hepatic failure
Systolic blood pressure less than 100 mmHg
Inflammatory and autoimmune diseases
Diabetes mellitus
Chronic heart failure
Malignancy
Psychiatric disorders
Dapagliflozin contraindications
History of receiving dapagliflozin
History of myocardial infarction
Arrival more than 6 hours from symptoms onset
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Age
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From 18 years old to 80 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
100
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Arrangement of the randomization process: Determining each block size (quadruple blocks), Preparing the list of the blocks, and assigning a number to each of them AABB(1) ABAB(2) ABBA(3) BBAA(4) BABA(5) BAAB(6),
Choosing random numbers between 1 and 6 by Excel software, Defining the treatment assignment list.
For example: AABB(1)_BBAA(4)_ABAB(2)_BABA(5)
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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This study is double-blind and none of the patients and researchers will know about the process of assigning patients to the intervention and placebo groups. For this purpose, dapagliflozin and placebo will be similarly packaged and given to the patient. Also, dapagliflozin and placebo tablets will have the same shape, color, and size.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-04-17, 1402/01/28
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Ethics committee reference number
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IR.TBZMED.REC.1402.086
Health conditions studied
1
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Description of health condition studied
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Myocardial infarction
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ICD-10 code
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I21
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ICD-10 code description
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ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
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Description
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ST-segment resolution
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Timepoint
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Before intervention and 90 min after intervention
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Method of measurement
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Electrocardiogram
2
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Description
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Cardiac troponin I
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Timepoint
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before intervention and then every 6 hours for the first 24 hours after intervention and every 12 hours to 72 hours after intervention
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Method of measurement
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ELISA test
3
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Description
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High-sensitivity C-reactive protein (hs-CRP)
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Timepoint
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Before the intervention and 3 days after the intervention
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Method of measurement
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Immunoturbidimetry method
4
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Description
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Cardiac ejection fraction
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Timepoint
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Before the intervention and 40 days after the intervention
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Method of measurement
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Echocardiography
5
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Description
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Major adverse cardiac events
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Timepoint
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Within 40 days after Intervention
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Method of measurement
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Interview
6
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Description
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Quality of life
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Timepoint
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Before the intervention and 40 days after the intervention
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Method of measurement
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MacNew questionaire
Intervention groups
1
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Description
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The Intervention group will receive oral dapagliflozin of Modava pharmaceutical 10mg/day for 40 days in addition to usual treatments.
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Category
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Treatment - Drugs
2
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Description
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The Control group will receive oral placebo of Modava pharmaceutical daily for 40 days along with usual treatments.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All of the data of article can be published after making patients unrecognized.
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When the data will become available and for how long
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After publishing of article until 6 months after publishing of the results
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To whom data/document is available
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Data will be available to researchers working in academic and scientific institutions.
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Under which criteria data/document could be used
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Researchers who request data will be permitted only to do analysis according to ethics for scientific aims.
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From where data/document is obtainable
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Applicants can receive data by sending an E-mail to address of tentezari@gmail.com and get response from Dr. Taher Entezari Maleki.
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What processes are involved for a request to access data/document
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After contacting the corresponding author(Dr. Taher Entezari Maleki), data will be sent to the Tabriz Shahid Madani hospital ethics committee and after receiving permission, data will be sent to applicants.
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Comments
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