Cardio-protective Effect of Metformin in Patients Undergoing PCI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-09

Study Completion Date

2024-12-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Elective Percutaneous Coronary Intervention Ischemic Reperfusion Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Metformin 500 mg twice

Comparator

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Metformin

Metformin 500 mg twice

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes