Cardio-protective Effect of Metformin in Patients Undergoing PCI

NCT05708053 | Unknown Phase 3

• 1 other identifier: December-2019
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

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).

Conditions

Elective Percutaneous Coronary Intervention; Ischemic Reperfusion Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• CK-MB

  24 hours post PCI

• cTn

  24 hours post PCI

• LVEF in percent

  Baseline- 6 months

• LVMI in g/m2

  Baseline- 6 months

• GFR

  Baseline- monthly- 6 months

Study Arms (2)

Metformin Group

EXPERIMENTAL

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

Comparator

NO INTERVENTION

Patients will receive pre-treatment and post treatment standard of care to the procedure

Interventions

Metformin DRUG

Metformin 500 mg twice

Metformin Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Future University in Egypt: lead
• Cairo University: collaborator

Study Sites (3)

Faculty of Pharmacy, Cairo University

Cairo, Egypt

Location

Kasr El Aini Hospital

Cairo, Egypt

Location

Kasr El-Aini Hospital

Cairo, Egypt

Location

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: February 1, 2023
• Study Start: December 9, 2019
• Primary Completion: December 9, 2021
• Study Completion: December 1, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

EG (3)