Evaluating the effects of empagliflozin in preventing myocardial damage in patients undergoing percutaneous coronary intervention: a double-blind randomized clinical trial
Evaluating the effects of empagliflozin in preventing myocardial damage in patients undergoing percutaneous coronary intervention
Design
This study is a clinical trial with a control group with parallel and double-blind groups.Phase 3 of the study will be conducted on 90 patients with ischemic heart diseases who undergo angioplasty.Patients are divided randomly, using table of random numbers into two intervention groups with empagliflozin (45 people) and the control group, placebo (45 people)
Settings and conduct
Patients with acute myocardial infarction at the Department of Cardiology, Madani Hospital, Tabriz, Iran, were chosen. In this double-blind study, the clinical care and patient were blind to group assignment and the type of treatment.
Participants/Inclusion and exclusion criteria
All consented patients with ischemic heart diseases aged 18-80 and undergoing of angioplasty and stent insertion will be entered and if history of open heart surgery in the last 3 months and inability in filling and understanding of the consent forminability in filling and understanding of the consent form will be prohibited from entering the study.
Intervention groups
Intervention group: The recipient of empagliflozin 25 mg tablets manufactured by Farmashi Pharmaceutical Company, Iran, one day and one to two hours before coronary intervention.The placebo are prescribed the day before and 1-2 hours before the intervention
Main outcome variables
The level of cTnI and hs-CRP
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221102056378N1
Registration date:2022-11-07, 1401/08/16
Registration timing:prospective
Last update:2022-11-07, 1401/08/16
Update count:0
Registration date
2022-11-07, 1401/08/16
Registrant information
Name
Hosein Behzad Vakilabad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3554 1221
Email address
hbehzad.pharma@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-11, 1401/08/20
Expected recruitment end date
2023-11-11, 1402/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effects of empagliflozin in preventing myocardial damage in patients undergoing percutaneous coronary intervention: a double-blind randomized clinical trial
Public title
Evaluating the effects of empagliflozin in preventing myocardial damage in patients undergoing percutaneous coronary intervention
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-80 years
Ischemic heart diseases patients
candidate for angioplasty and stentstent insertion
Filling of consent form
Exclusion criteria:
History of infarction
History of open heart surgery in the last 3 months
Renal dysfunction
Dialysis
Failed History of Coronary Angioplasty
cardiogenic shock
cancer
Liver failure
Autoimmune disease
Pregnancy
History of serious allergy to empagliflozin
Inability in filling and understanding of the consent form
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are divided into two groups of 45 people using the Graphpad prism software and 1:1 randomization, group A as the intervention group and group B as the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study was double-blind and coded A and B, and the participants and the percutaneous coronary surgeon will not know the type of grouping.
The intervention group will receive empagliflozin 25 mg and the control group will receive placebo, but they will receive drugs with code A and B. All participants will undergo percutaneous coronary surgery by the same team and the same method.
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
Third Floor; Central Building of Number2; Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2022-10-29, 1401/08/07
Ethics committee reference number
IR.TBZMED.REC.1401.673
Health conditions studied
1
Description of health condition studied
Cardiovascular disease
ICD-10 code
429.2
ICD-10 code description
Cardiovascular disease, unspecified
Primary outcomes
1
Description
cTnI level
Timepoint
8 hours and 24 hours after the intervention
Method of measurement
ELISA kits
2
Description
hs-CRP level
Timepoint
24 hours after the intervention
Method of measurement
ELISA kits
Secondary outcomes
1
Description
Major Adverse Cardiac Effects
Timepoint
1 month after hospital discharge
Method of measurement
Follow up by phone
Intervention groups
1
Description
Intervention group: The recipient of empagliflozin 25 mg tablets manufactured by Farmashi Pharmaceutical Company, Iran, one day and one to two hours before coronary intervention.
Category
Prevention
2
Description
Control group: The placebo are prescribed the day before and 1-2 hours before the intervention
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Hospital
Full name of responsible person
Hossein Behzad Vakilabad
Street address
Shahid Madani Hospital, Daneshgah st.
City
Tabriz
Province
East Azarbaijan
Postal code
5163639889
Phone
+98 41 3337 3900
Email
Madanihearthosp@tbzmed.ac.ir
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 3rd Floor, Daneshgah st. Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Phone
+98 41 3334 8801
Email
shahabip@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Hosein Behzad Vakilabad
Position
Clinical Specialist Assistant
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Phone
+98 41 3554 1221
Fax
Email
hbehzad.pharma@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hosein Behzad Vakilabad
Position
Clinical Specialist Assistant
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Phone
+98 41 3554 1221
Fax
Email
hbehzad.pharma@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hossein Behzad vakilabad
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Golgasht st Attar Neishaboori st. Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Phone
+98 41 3334 8801
Email
hbehzad.pharma@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available