Cardio-protective Effect of Metformin in Patients Undergoing PCI

Phase 3

Active, not recruiting

• Conditions: Ischemic Reperfusion Injury; Elective Percutaneous Coronary Intervention
• Interventions: Drug: Metformin

• Registration Number: NCT05708053
• Lead Sponsor: Future University in Egypt

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-09
• Primary Completion: 2021-12-09
• Study First Submitted: 2023-01-09
• Study First Submitted QC: 2023-01-24
• Study First Posted: 2023-02-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-13
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin Group	Metformin	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.

Primary Outcome Measures

Name	Time	Method
Postprocedural myocardial injury	6 months	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

Name	Time	Method
Glucometabolic State	Baseline - 6 months	Glucometabolic State using HbA1c (unit mmols/mol)
cTn	24 hours post PCI	Mean peak values of cTnI after intervention
LVEF in percent	Baseline- 6 months	Echo: to measure LVEF in percent
Rate of hospitalization	through study completion, an average of 6 months	The number of hospitalizations within each group will be calculated during the study period.
CK-MB	24 hours post PCI	Mean peak values of CK-MB after intervention
Serum creatinine (SCr)	Baseline- monthly- 6 months	Serum creatinine (SCr) in mg/dL
Lactate concentration	Baseline - 6 months	lactate concentration unit in mmol/L
Incidence of Cardiovascular Event	Baseline - 6 months	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.
GFR	Baseline- monthly- 6 months	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
LVMI in g/m2	Baseline- 6 months	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

Trial Locations

Locations (3)

Faculty of Pharmacy, Cairo University; 🇪🇬 Cairo, Egypt

Kasr El Aini Hospital; 🇪🇬 Cairo, Egypt

Kasr El-Aini Hospital; 🇪🇬 Cairo, Egypt