Cardio-protective Effect of Metformin in Patients Undergoing PCI

• Sponsor: Future University in Egypt (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05708053
• Collaborator: Cairo University (Other), Cairo University Hospitals (Other)
• Enrollment: 80
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 59.8
• Patients Per Site: 26.7
• Patients Per Site Per Month: 0.4

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Elective Percutaneous Coronary Intervention; Ischemic Reperfusion Injury	Drug: Metformin	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Cardio-protective Effect of Metformin in Patients Undergoing Elective Percutaneous Coronary Intervention
• Actual Study Start Date: Dec 9, 2019
• Actual Primary Completion Date: Dec 9, 2021
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. CK-MB [24 hours post PCI]

   Mean peak values of CK-MB after intervention

2. cTn [24 hours post PCI]

   Mean peak values of cTnI after intervention

3. LVEF in percent [Baseline- 6 months]

   Echo: to measure LVEF in percent

4. 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

5. 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

6. Serum creatinine (SCr) [Baseline- monthly- 6 months]

   Serum creatinine (SCr) in mg/dL

7. Lactate concentration [Baseline - 6 months]

   lactate concentration unit in mmol/L

8. Glucometabolic State [Baseline - 6 months]

   Glucometabolic State using HbA1c (unit mmols/mol)

9. 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.

10. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Pharmacy, Cairo University	Cairo		Egypt
2	Kasr El Aini Hospital	Cairo		Egypt
3	Kasr El-Aini Hospital	Cairo		Egypt

Sponsors and Collaborators

• Future University in Egypt
• Cairo University
• Cairo University Hospitals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Radwa Abdelatif, Principal Investigator, Future University in Egypt
• ClinicalTrials.gov Identifier: NCT05708053
• Other Study ID Numbers: December-2019
• First Posted: Feb 1, 2023
• Last Update Posted: Feb 1, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Reperfusion Injury; Metformin

Study Results

No Results Posted as of Feb 1, 2023