To Study the effect of Empagliflozin on the Incidence of short-term major Cardiovascular events in type 2 diabetic patients with myocardial infarction requiring primary angioplasty
Evaluation of the effect of ampagliflozin on the occurrence of short-term major cardiovascular events in type 2 diabetic patients with myocardial infarction requiring primary angioplasty in order to use it to prevent type 2 diabetic patients from developing cardiovascular events
Design
A clinical trial with a control and intervention group with parallel,double-blind, randomized phase 2 groups on 200 patients, ٌWill use the Rand function of Excel software for randomization..
Settings and conduct
The study will perform as a double-blind clinical trial in Mousavi Hospital in Zanjan. Patients were randomly admitted to the study according to the inclusion criteria so that neither the researcher nor the patient knew about the control and intervention groups. Medication and placebo are given to both groups for 3 months, and information on blood glucose levels and the incidence of cardiovascular events will review for up to 3 months.
Participants/Inclusion and exclusion criteria
Admission: Type 2 diabetic patients (treated with oral medications)
- Diabetic patients with MI and previous treatment with metformin, sulfonylurea
No entry: cardiogenic shock
- Hypoglycemia
-Diabetic ketoacidosis
-History of coronary artery bypass surgery
-Type 1 diabetes
-Severe liver failure
- Patients with advanced cancer
-History of empagliflozin allergy
- Hypovolemia
-Severe renal failure
-History of cancer
- Any inflammatory disease under treatment
-Advanced heart failure
Intervention groups
Evaluation of the efficacy of ampagliflozin on cardiovascular events after myocardial infarction in two groups of intervention (ampagliflozin recipient) and control (placebo recipient)
Main outcome variables
Short-term cardiovascular events after myocardial infarction such as death, heart failure, ventricular arrhythmia, readmission, re-infarction, stroke, myocardial infarction and the need for cardiopulmonary resuscitation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210710051833N1
Registration date:2022-06-22, 1401/04/01
Registration timing:prospective
Last update:2022-06-22, 1401/04/01
Update count:0
Registration date
2022-06-22, 1401/04/01
Registrant information
Name
Zahra Kalantari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3552 5654
Email address
zahra_kalantari88@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To Study the effect of Empagliflozin on the Incidence of short-term major Cardiovascular events in type 2 diabetic patients with myocardial infarction requiring primary angioplasty
Public title
Study the effect of Empagliflozin in type 2 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetic patients (treated with oral hypoglycemic drugs) with STEMI (typical chest pain lasting more than 30 minutes during the 12 hours prior to admission, with ST-segment elevation above 0.1 mV in both Lead or more on ECG) who will be admitted to Ayatollah Mousavi Hospital in Zanjan between August and October 1401
Diabetic patients with MI who have previously received prior treatment with metformin, sulfonylureas, or a combination of these two drugs.
Exclusion criteria:
Cardiogenic shock
Hypoglycemia
Diabetic ketoacidosis
History of coronary artery bypass surgery
Type 1 diabetes
Severe liver failure
Patients with advanced cancer
History of severe hypersensitivity to empagliflozin or its components
Severe renal failure (eGFR <30 mL / minute / 1.73 m2), end-stage renal disease (ESRD) or dialysis
Hypovolemia
Any inflammatory disease being treated
History of any cancer
Advanced heart failure
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be performed as a double blind clinical trial. In such a way that neither the researcher nor the patient knows which group will be treated with the drug or placebo, and the drug and the placebo will be provided to the patients by coding a third party (co-planner).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zanjan University of Medical Sciences
Street address
Azadi Blvd,Vice-Chancellor for Research and Technology
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2021-10-21, 1400/07/29
Ethics committee reference number
IR.ZUMS.REC.1400.326
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E11.69
ICD-10 code description
Type 2 diabetes mellitus with other specified complication
2
Description of health condition studied
Heart disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mortality associated with cardiovascular events
Timepoint
Hospitalization time and one month and three months later
Method of measurement
Monthly face-to-face visits, tests and echoes
Secondary outcomes
1
Description
Ventricular arrhythmia
Timepoint
Three months after hospitalization and intervention
Method of measurement
Review of patient's hospital records during three months
2
Description
Re-infarction
Timepoint
Three months after hospitalization and intervention
Method of measurement
Review of patient's hospital records and echo
3
Description
Need for cardiopulmonary resuscitation
Timepoint
Three months after hospitalization and intervention
Method of measurement
Review of patient's hospital records during three months
4
Description
Congestive heart failure
Timepoint
Three months after hospitalization and intervention
Method of measurement
Review of patient's hospital records and echo
5
Description
Requires revascularization of target vessels
Timepoint
Three months after hospitalization and intervention
Method of measurement
Review of patient's hospital records during three months
6
Description
Stroke
Timepoint
Three months after hospitalization and intervention
Method of measurement
Review of patient's hospital records during three months
7
Description
Cardiogenic shock
Timepoint
Three months after hospitalization and intervention
Method of measurement
Review of patient's hospital records during three months
Intervention groups
1
Description
Intervention group Diabetic patients who presented with myocardial infarction and received 10 mg daily ampagliflozin tablets for three months.
Category
Treatment - Drugs
2
Description
Control group: Diabetic patients who presented with a heart attack and received a placebo daily for three months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Moosavi Hospital
Full name of responsible person
Zahra Kalantari
Street address
Moosavi Hospital, Prof. Sabouti Boulevard (Gavazang Road).
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Fax
+98 24 3313 1203
Email
Zahra_kalantari88@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Zahra Meschi
Street address
Deputy of research and technology, Azadi Blvd
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3315 6141
Fax
+98 24 3342 0460
Email
research@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Dr. Abidi Pharmaceutical Company
Proportion provided by this source
92
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Zahra Kalantari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
No. 18 , Azadegan Ave, Ahmadlo Blvd.
City
Zanjan
Province
Zanjan
Postal code
4513753111
Phone
+98 24 3552 5654
Fax
Email
Zahra_kalantari88@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Zahra Kalantari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
No. 18 , Azadegan Ave., Ahmadlo Blvd.
City
Zanjan
Province
Zanjan
Postal code
4513753111
Phone
+98 24 3552 5654
Fax
Email
Zahra_kalantari88@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Zahra Kalantari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
No. 18 , Azadegan Ave.Ahmadlo Blvd.
City
Zanjan
Province
Zanjan
Postal code
4513753111
Phone
+98 24 3552 5654
Fax
Email
Zahra_kalantari88@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Study data including (personal information, test results and outcomes) will be available in encrypted form in special forms designed to follow patients.
When the data will become available and for how long
The beginning of the data access period will be after the publication of the results in April 1402.
To whom data/document is available
Documentation will be available to researchers working in academic and scientific institutions.
Access to data will be possible for people working in industry by fully introducing and clarifying the purpose of use.
Under which criteria data/document could be used
The use of data will be allowed only with the full introduction of researchers and clarification of the purposes of using the data and for use in future scientific issues and research.
From where data/document is obtainable
To access the data, you can contact Dr. Zahra Kalantari's researcher via e-mail Zahra_kalantari88@yahoo.com and work address (Zanjan, Gavazang Boulevard, Mousavi Hospital).
What processes are involved for a request to access data/document
جهت دسترسی به داده ها پس از تماس با محقق از طریق ایمیا یا نشانی، پس از معرفی کامل فرد درخواست کننده و بیان هدف استفاده از داده ها، در طول مدت کمتر از یک ماه امکان دسترسی به داده ها وجود خواهد داشت.