Clinical trial
Cardio-protective Effect of Metformin in Patients Undergoing Elective Percutaneous Coronary Intervention
Name
December-2019
Description
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).
Trial arms
Trial start
2019-12-09
Estimated PCD
2021-12-09
Trial end
2024-12-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Metformin
Metformin 500 mg twice
Arms:
Metformin Group
Size
80
Primary endpoint
Postprocedural myocardial injury
6 months
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2023-09-13
1 organization
1 drug
2 indications
Organization
Future University in EgyptDrug
MetforminIndication
Percutaneous Coronary InterventionIndication
Ischemic Reperfusion Injury