Back to resultsCardio-protective Effect of Metformin in Patients Undergoing PCI
Primary Purpose
Elective Percutaneous Coronary Intervention, Ischemic Reperfusion Injury
Status
Active
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Metformin
Sponsored by
About this trial
This is an interventional prevention trial for Elective Percutaneous Coronary Intervention
Eligibility Criteria
Inclusion Criteria: Adult patients (age above 18) Undergoing elective PCI Exclusion Criteria: Hypersensitivity to metformin or any component of the formulation Patients with current or any history taking metformin either for diabetes mellitus or any other reason such as polycystic ovarian syndrome. Patients diagnosed with type 1 or 2 diabetes mellitus. Any oral or injectable hypoglycemic therapy (e.g. insulin, sulfonylureas) Severe renal dysfunction (eGFR less than 30 mL/minute/1.73 m2 ) from any cause, including shock or septicemia; acute or chronic metabolic acidosis with or without coma (including diabetic ketoacidosis). Treatment with systemic glucocorticoids within 3 months of randomization (due to its potential effect on plasma glucose and HbA1c levels). Metabolic acidosis (total CO 2 below the laboratory lower limit of normal on most recent blood chemistry panel). Need for coronary artery bypass grafting. Participation in other clinical trial in the 30 days before enrollment. The existence of a life-threatening disease with a life-expectancy of less than 6 months.
Sites / Locations
- Faculty of Pharmacy, Cairo University
- Kasr El Aini Hospital
- Kasr El-Aini Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Metformin Group
Comparator
Arm Description
Patients will receive pre-treatment standard and post treatment of care to the procedure plus metformin 500 mg twice daily 7 days before and 6 months after the PCI procedure. Metformin will be stopped on the same day of the procedure and restored 3 hours after the procedure.
Patients will receive pre-treatment and post treatment standard of care to the procedure
Outcomes
Primary Outcome Measures
Postprocedural myocardial injury
the occurrence of postprocedural myocardial injury, defined as a postprocedural elevation of CKMB or cTnI more than 1 times the 99 th percentile of the URL [ 24 hours post PCI]
Secondary Outcome Measures
CK-MB
Mean peak values of CK-MB after intervention
cTn
Mean peak values of cTnI after intervention
LVEF in percent
Echo: to measure LVEF in percent
LVMI in g/m2
left ventricular mass index (LVMI) will be calculated in g/m2 using the sex and body surface area (m²) and measures of LVEDD in mm, IVSd in mm, PWd from the measures in the echocardiography
GFR
glomerular filtration rate (GFR) will be calculated (unit ml/min) using age in years, sex, body weight in kilograms and serum creatinine in mg/dL
Serum creatinine (SCr)
Serum creatinine (SCr) in mg/dL
Lactate concentration
lactate concentration unit in mmol/L
Glucometabolic State
Glucometabolic State using HbA1c (unit mmols/mol)
Incidence of Cardiovascular Event
Cardiovascular events including major cardiac adverse events (MACE; death, recurrent MI, target lesion revascularization), stroke, non-elective hospitalizations for chest pain or heart failure, all recurrent coronary interventions, and internal cardiac defibrillator implantations. Mortality will be divided into cardiac and non- cardiac. Cardiac death will be divided into three categories: heart failure, sudden death, and others.
Rate of hospitalization
The number of hospitalizations within each group will be calculated during the study period.
Full Information
NCT ID
NCT05708053
First Posted
January 9, 2023
Last Updated
September 12, 2023
Sponsor
Future University in Egypt
Collaborators
Cairo University, Cairo University Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT05708053
Brief Title
Cardio-protective Effect of Metformin in Patients Undergoing PCI
Official Title
Cardio-protective Effect of Metformin in Patients Undergoing Elective Percutaneous Coronary Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 9, 2019 (Actual)
Primary Completion Date
December 9, 2021 (Actual)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Future University in Egypt
Collaborators
Cairo University, Cairo University Hospitals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a two-arm randomized parallel study. Patients who will be meeting the above-mentioned criteria and agree to take part in the study, were asked to sign an informed consent prior conducting the study.
The whole study protocol were presented to the local institutional review board (IRB).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elective Percutaneous Coronary Intervention, Ischemic Reperfusion Injury
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Metformin Group
Arm Type
Experimental
Arm Description
Patients will receive pre-treatment standard and post treatment of care to the procedure plus metformin 500 mg twice daily 7 days before and 6 months after the PCI procedure.
Metformin will be stopped on the same day of the procedure and restored 3 hours after the procedure.
Arm Title
Comparator
Arm Type
No Intervention
Arm Description
Patients will receive pre-treatment and post treatment standard of care to the procedure
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Metformin 500 mg twice
Primary Outcome Measure Information:
Title
Postprocedural myocardial injury
Description
the occurrence of postprocedural myocardial injury, defined as a postprocedural elevation of CKMB or cTnI more than 1 times the 99 th percentile of the URL [ 24 hours post PCI]
Time Frame
6 months
Secondary Outcome Measure Information:
Title
CK-MB
Description
Mean peak values of CK-MB after intervention
Time Frame
24 hours post PCI
Title
cTn
Description
Mean peak values of cTnI after intervention
Time Frame
24 hours post PCI
Title
LVEF in percent
Description
Echo: to measure LVEF in percent
Time Frame
Baseline- 6 months
Title
LVMI in g/m2
Description
left ventricular mass index (LVMI) will be calculated in g/m2 using the sex and body surface area (m²) and measures of LVEDD in mm, IVSd in mm, PWd from the measures in the echocardiography
Time Frame
Baseline- 6 months
Title
GFR
Description
glomerular filtration rate (GFR) will be calculated (unit ml/min) using age in years, sex, body weight in kilograms and serum creatinine in mg/dL
Time Frame
Baseline- monthly- 6 months
Title
Serum creatinine (SCr)
Description
Serum creatinine (SCr) in mg/dL
Time Frame
Baseline- monthly- 6 months
Title
Lactate concentration
Description
lactate concentration unit in mmol/L
Time Frame
Baseline - 6 months
Title
Glucometabolic State
Description
Glucometabolic State using HbA1c (unit mmols/mol)
Time Frame
Baseline - 6 months
Title
Incidence of Cardiovascular Event
Description
Cardiovascular events including major cardiac adverse events (MACE; death, recurrent MI, target lesion revascularization), stroke, non-elective hospitalizations for chest pain or heart failure, all recurrent coronary interventions, and internal cardiac defibrillator implantations. Mortality will be divided into cardiac and non- cardiac. Cardiac death will be divided into three categories: heart failure, sudden death, and others.
Time Frame
Baseline - 6 months
Title
Rate of hospitalization
Description
The number of hospitalizations within each group will be calculated during the study period.
Time Frame
through study completion, an average of 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult patients (age above 18)
Undergoing elective PCI
Exclusion Criteria:
Hypersensitivity to metformin or any component of the formulation
Patients with current or any history taking metformin either for diabetes mellitus or any other reason such as polycystic ovarian syndrome.
Patients diagnosed with type 1 or 2 diabetes mellitus.
Any oral or injectable hypoglycemic therapy (e.g. insulin, sulfonylureas)
Severe renal dysfunction (eGFR less than 30 mL/minute/1.73 m2 ) from any cause, including shock or septicemia; acute or chronic metabolic acidosis with or without coma (including diabetic ketoacidosis).
Treatment with systemic glucocorticoids within 3 months of randomization (due to its potential effect on plasma glucose and HbA1c levels).
Metabolic acidosis (total CO 2 below the laboratory lower limit of normal on most recent blood chemistry panel).
Need for coronary artery bypass grafting.
Participation in other clinical trial in the 30 days before enrollment.
The existence of a life-threatening disease with a life-expectancy of less than 6 months.
Facility Information:
Facility Name
Faculty of Pharmacy, Cairo University
City
Cairo
Country
Egypt
Facility Name
Kasr El Aini Hospital
City
Cairo
Country
Egypt
Facility Name
Kasr El-Aini Hospital
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Cardio-protective Effect of Metformin in Patients Undergoing PCI
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