Cardio-protective Effect of Metformin in Patients Undergoing PCI

Cardio-protective Effect of Metformin in Patients Undergoing Elective Percutaneous Coronary Intervention

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Ischemic Reperfusion Injury; Elective Percutaneous Coronary Intervention
• Intervention / Treatment: Drug: Metformin

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Kasr El Aini Hospital
  • Cairo, Egypt
    • Kasr El-Aini Hospital
  • Cairo, Egypt
    • Faculty of Pharmacy, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adult patients (age above 18)
• Undergoing elective PCI

Exclusion Criteria:

1. Hypersensitivity to metformin or any component of the formulation
2. Patients with current or any history taking metformin either for diabetes mellitus or any other reason such as polycystic ovarian syndrome.
3. Patients diagnosed with type 1 or 2 diabetes mellitus.
4. Any oral or injectable hypoglycemic therapy (e.g. insulin, sulfonylureas)
5. 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).
6. Treatment with systemic glucocorticoids within 3 months of randomization (due to its potential effect on plasma glucose and HbA1c levels).
7. Metabolic acidosis (total CO 2 below the laboratory lower limit of normal on most recent blood chemistry panel).
8. Need for coronary artery bypass grafting.
9. Participation in other clinical trial in the 30 days before enrollment.
10. The existence of a life-threatening disease with a life-expectancy of less than 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Metformin Group; 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.	Drug: Metformin; Metformin 500 mg twice
No Intervention: Comparator; Patients will receive pre-treatment and post treatment standard of care to the procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CK-MB	Mean peak values of CK-MB after intervention	24 hours post PCI
cTn	Mean peak values of cTnI after intervention	24 hours post PCI
LVEF in percent	Echo: to measure LVEF in percent	Baseline- 6 months
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	Baseline- 6 months
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	Baseline- monthly- 6 months
Serum creatinine (SCr)	Serum creatinine (SCr) in mg/dL	Baseline- monthly- 6 months
Lactate concentration	lactate concentration unit in mmol/L	Baseline - 6 months
Glucometabolic State	Glucometabolic State using HbA1c (unit mmols/mol)	Baseline - 6 months
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.	Baseline - 6 months
Rate of hospitalization	The number of hospitalizations within each group will be calculated during the study period.	through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Future University in Egypt
• Collaborators: Cairo University; Cairo University Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2019
• Primary Completion (Actual): December 9, 2021
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: January 24, 2023
• First Posted (Actual): February 1, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Reperfusion Injury; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: December-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No