Investigating the effect of Empagliflozin on outcomes of patients with myocardial infarction undergoing primary Percutaneous coronary intervention (PCI):a randomized double-blind clinical trial with placebo
Investigating the effect of Empagliflozin on outcomes of patients with myocardial infarction undergoing primary PCI-a randomized double-blind clinical trial with placebo
Design
Double blind, randomized Clinical trial (phase 3) with control and parallel groups on 54 patients.
https://www.sealedenvelope.com is used for randomization
Settings and conduct
Double-blind clinical trial including patients with ST-elevation myocardial infarction (STEMI) undergoing successful Primary Percutaneous Coronary Intervention (PCI) in rasht Heshmat hospital.
Participants/Inclusion and exclusion criteria
This is a clinical trial including patients with STEMI undergoing successful Primary PCI in Rasht Heshmat hospital.
In all control ad intervention groups, MACE, LVEF at first admission day and after 40-day follow up, recurrent angina and rehospitalization will be checked.
Inclusion criteria:
1. patients with STEMI undergoing successful Primary PCI
2. .Based on NYHA functional class I,II,III
3. Consciously satisfaction
Exclusion criteria:
1. Failure of primary PCI
2. Empagliflozin contraindications
3. Valvular heart disease with moderate and higher severity
4. Patients who need hemodynamic support during hospitalization
5. Not willing to continue participation in study
6. Receiving drugs ,eg NSAIDs which can not be denied
Intervention groups
Intervention group: Receiving Empagliflozin 10 mg 1 tablet daily. Made by ACTOVER co.
Control group: Receiving Placebo (cellulose micro crystal tablet). 1 tablet daily.
Main outcome variables
Major adverse cardiac events (MACE) including stroke, cardiac mortality, reinfarction during 40-day follow up
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220809055645N7
Registration date:2024-02-17, 1402/11/28
Registration timing:prospective
Last update:2024-02-17, 1402/11/28
Update count:0
Registration date
2024-02-17, 1402/11/28
Registrant information
Name
Fatemeh Baharvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3361 8177
Email address
dr.baharcardio@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-05, 1402/12/15
Expected recruitment end date
2024-09-06, 1403/06/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Empagliflozin on outcomes of patients with myocardial infarction undergoing primary Percutaneous coronary intervention (PCI):a randomized double-blind clinical trial with placebo
Public title
The effect of Empagliflozin on outcomes of patients with myocardial infarction undergoing primary PCI
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ST segment elevation myocardial infarction (STEMI) undergoing successful Primary PCI without complications
Based on New York Heart Association (NYHA) functional class I,II,III
Informed consent for participation in study
Exclusion criteria:
Failure of primary PCI
Empagliflozin contraindications
Valvular heart disease with moderate and higher severity
Patients who need hemodynamic support during hospitalization
Not willing to continue participation in study
Receiving drugs ,eg Non-steroidal anti-inflammatory drugs (NSAIDs) which can not be denied
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 54 patients according to inclusion criteria, with block randomization group with 1:1 ratio as 2 groups(A: intervention and B: placebo) will enter this study. with Blocking randomization we give each patient a number from 1 to 54. Then a table with 9 rows named block that each block has 6 segments, will be considered and then the numbers will be placed respectively in the rows. After all numbers placed in blocks, all patients with code A, receive drug andpatients with code B receive placebo.
https://www.sealedenvelope.com is used for randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and researchers are blind. A third person out of the study, based on randomization allocates the placebo and drug to researcher.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Guilan University of Medical Sciences
Street address
Namjoo
City
Rasht
Province
Guilan
Postal code
41446-66949
Approval date
2024-01-17, 1402/10/27
Ethics committee reference number
IR.GUMS.REC.1402.530
Health conditions studied
1
Description of health condition studied
ST Elevation myocardial infarction
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
Description
Myocardial reinfarction
Timepoint
During 40-day follow up
Method of measurement
According to symptoms and ECG findings
2
Description
Stroke
Timepoint
During 40-day follow up
Method of measurement
According to symptoms and physical examinations
3
Description
Cardiac mortality
Timepoint
During 40-day follow up
Method of measurement
Cardiac death according to AHA guideline determined as paroxysmal cardiac arrest with no respiratory and circulatory response
Secondary outcomes
1
Description
Ejection fraction
Timepoint
During 40-day follow up
Method of measurement
By echocardiography
2
Description
Systolic heart failure
Timepoint
During 40-day follow up
Method of measurement
By echocardiography
3
Description
Re admission
Timepoint
During 40-day follow up
Method of measurement
Documented records
4
Description
Angina
Timepoint
During 40-day follow up
Method of measurement
History
5
Description
Second revascularization
Timepoint
During 40-day follow up
Method of measurement
Based on symptoms ECG and echocardiographic findings
6
Description
Empagliflozin complications
Timepoint
During 40-day follow up
Method of measurement
Based on history, symptoms and echocardiography findings.
Intervention groups
1
Description
Intervention group: Receiving Empagliflozin 10 mg 1 tablet daily. Made by Actover co.