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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05708053
Other study ID # December-2019
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date December 9, 2019
Est. completion date December 2024

Study information

Verified date September 2023
Source Future University in Egypt
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 80
Est. completion date December 2024
Est. primary completion date December 9, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Metformin
Metformin 500 mg twice

Locations

Country Name City State
Egypt Faculty of Pharmacy, Cairo University Cairo
Egypt Kasr El Aini Hospital Cairo
Egypt Kasr El-Aini Hospital Cairo

Sponsors (3)

Lead Sponsor Collaborator
Future University in Egypt Cairo University, Cairo University Hospitals

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 CK-MB Mean peak values of CK-MB after intervention 24 hours post PCI
Secondary cTn Mean peak values of cTnI after intervention 24 hours post PCI
Secondary LVEF in percent Echo: to measure LVEF in percent Baseline- 6 months
Secondary 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
Secondary 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
Secondary Serum creatinine (SCr) Serum creatinine (SCr) in mg/dL Baseline- monthly- 6 months
Secondary Lactate concentration lactate concentration unit in mmol/L Baseline - 6 months
Secondary Glucometabolic State Glucometabolic State using HbA1c (unit mmols/mol) Baseline - 6 months
Secondary 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
Secondary 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
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