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General information
empty
DAPA-STEMI
DAPA-STEMI
empty
Adding the abbreviated name of the trial
Adding the abbreviated name of the trial
empty
اضافه کردن نام اختصاری مطالعه
اضافه کردن نام اختصاری مطالعه
Recruitment centers
#1
Name of recruitment center - English: Shahid Madani Medical & Training Hospital
Name of recruitment center - Persian: مرکز آموزشی و درمانی قلب و عروق شهید مدنی تبریز
Full name of responsible person - English: Dr. Taher Entezari-Maleki
Full name of responsible person - Persian: دکتر طاهر انتظاری ملکی
Street address - English: Daneshgah Street, Shahid Madani Hospital
Street address - Persian: خيابان دانشگاه، بیمارستان شهید مدنی
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5166614766
Phone: +98 41 3337 3901
Fax:
Email: tentezari@gmail.com
Web page address:
Name of recruitment center - English: Shahid Madani Medical & Training Hospital
Name of recruitment center - Persian: مرکز آموزشی و درمانی قلب و عروق شهید مدنی تبریز
Full name of responsible person - English: Dr. Taher Entezari-Maleki
Full name of responsible person - Persian: دکتر طاهر انتظاری ملکی
Street address - English: Shahid Madani Hospital, Daneshgah Street
Street address - Persian: خيابان دانشگاه، بیمارستان شهید مدنی
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5166614766
Phone: +98 41 3337 3901
Fax:
Email: tentezari@gmail.com
Web page address:
Name of recruitment center - English: Shahid Madani Medical & Training Hospital Name of recruitment center - Persian: مرکز آموزشی و درمانی قلب و عروق شهید مدنی تبریز Full name of responsible person - English: Dr. Taher Entezari-Maleki Full name of responsible person - Persian: دکتر طاهر انتظاری ملکی Street address - English: Daneshgah Street, Shahid Madani Hospital, Daneshgah Street Street address - Persian: خيابان دانشگاه، بیمارستان شهید مدنی City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5166614766 Phone: +98 41 3337 3901 Fax: Email: tentezari@gmail.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Parviz Shahabi
Full name of responsible person - Persian: پرویز شهابی
Street address - English: International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street
Street address - Persian: خیابان گلگشت، دانشگاه علوم پزشکی تبریز ساختمان مرکزی شماره 2، طبقه سوم معاونت تحقیقات و فناوری
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5165665931
Phone: +98 41 3335 7310
Fax:
Email: research-vice@tbzmed.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Parviz Shahabi
Full name of responsible person - Persian: پرویز شهابی
Street address - English: No 2 Central Building, Tabriz University of Medical Sciences, Daneshgah Street
Street address - Persian: خیابان دانشگاه، دانشگاه علوم پزشکی تبریز، ساختمان مرکزی شماره 2
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5165665931
Phone: +98 41 3335 7310
Fax:
Email: research-vice@tbzmed.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Parviz Shahabi Full name of responsible person - Persian: پرویز شهابی Street address - English: International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, UniversityDaneshgah Street Street address - Persian: خیابان گلگشتدانشگاه، دانشگاه علوم پزشکی تبریز، ساختمان مرکزی شماره 2، طبقه سوم معاونت تحقیقات و فناوری City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5165665931 Phone: +98 41 3335 7310 Fax: Email: research-vice@tbzmed.ac.ir Web page address:
Protocol summary
Study aim
Effects of dapagliflozin in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention
Design
A controlled, parallel-group, double-blind, randomized, phase 3 clinical trial on 100 patients. Randomization was performed using permuted block randomization method.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
ST-segment resolution, Cardiac troponin I, hs-CRP, Ejection fraction, Major adverse cardiac events
General information
Reason for update
Adding the abbreviated name of the trial
Acronym
DAPA-STEMI
IRCT registration information
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
Registration date
2023-06-03, 1402/03/13
Registrant information
Name
Taher Entezari-Maleki
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
tentezarimaleki@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Dapagliflozin effects in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: a randomized clinical trial
Public title
Dapagliflozin effects in patients with myocardial infarction
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
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)
Blinding (investigator's opinion)
Double blinded
Blinding description
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Research & Technology Dept, Central Building No. 2, Third Floor, Tabriz University of Medical Sciences, Golghast St, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2023-04-17, 1402/01/28
Ethics committee reference number
IR.TBZMED.REC.1402.086
Health conditions studied
1
Description of health condition studied
Myocardial infarction
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
Description
ST-segment resolution
Timepoint
Before intervention and 90 min after intervention
Method of measurement
Electrocardiogram
2
Description
Cardiac troponin I
Timepoint
before intervention and then every 6 hours for the first 24 hours after intervention and every 12 hours to 72 hours after intervention
Method of measurement
ELISA test
3
Description
High-sensitivity C-reactive protein (hs-CRP)
Timepoint
Before the intervention and 3 days after the intervention
Method of measurement
Immunoturbidimetry method
4
Description
Cardiac ejection fraction
Timepoint
Before the intervention and 40 days after the intervention
Method of measurement
Echocardiography
5
Description
Major adverse cardiac events
Timepoint
Within 40 days after Intervention
Method of measurement
Interview
6
Description
Quality of life
Timepoint
Before the intervention and 40 days after the intervention
Method of measurement
MacNew questionaire
Secondary outcomes
empty
Intervention groups
1
Description
The Intervention group will receive oral dapagliflozin of Modava pharmaceutical 10mg/day for 40 days in addition to usual treatments.
Category
Treatment - Drugs
2
Description
The Control group will receive oral placebo of Modava pharmaceutical daily for 40 days along with usual treatments.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Medical & Training Hospital
Full name of responsible person
Dr. Taher Entezari-Maleki
Street address
Shahid Madani Hospital, Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3337 3901
Email
tentezari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
No 2 Central Building, Tabriz University of Medical Sciences, Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Taher Entezari Maleki
Position
دانشیار
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Madani Center, Daneshghah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3335 5983
Email
tentezari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Taher Entezari-Maleki
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Daneshghah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3335 5983
Email
tentezari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Taher Entezari-Maleki
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Daneshghah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3335 5983
Email
tentezari@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All of the data of article can be published after making patients unrecognized.
When the data will become available and for how long
After publishing of article until 6 months after publishing of the results
To whom data/document is available
Data will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Researchers who request data will be permitted only to do analysis according to ethics for scientific aims.
From where data/document is obtainable
Applicants can receive data by sending an E-mail to address of tentezari@gmail.com and get response from Dr. Taher Entezari Maleki.
What processes are involved for a request to access data/document
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.