Elective Percutaneous Coronary InterventionPhase 3NCT05708053
Cardio-protective Effect of Metformin in Patients Undergoing PCI
A Phase 3 study testing Metformin in people with Elective Percutaneous Coronary Intervention and Ischemic Reperfusion Injury, run by Future University in Egypt at 3 sites in Egypt.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elective Percutaneous Coronary Intervention, Ischemic Reperfusion Injury
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesEgypt
- Study dates
- 9 Dec 2019to 30 Dec 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients (age above 18)
- Undergoing elective PCI
Who cannot join
- 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).
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- 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.
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
Faculty of Pharmacy, Cairo University
Cairo
Kasr El Aini Hospital
Cairo
Kasr El-Aini Hospital
Cairo
About this study
Official title: Cardio-protective Effect of Metformin in Patients Undergoing Elective Percutaneous Coronary Intervention
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).
- Being tested
- Metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Metformin 500 mg twice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Metformin |
| Comparator | No intervention | Patients will receive pre-treatment and post treatment standard of care to the procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 6 months
Secondary outcomes (10)
CK-MB
Mean peak values of CK-MB after intervention
Measured: 24 hours post PCI
cTn
Mean peak values of cTnI after intervention
Measured: 24 hours post PCI
LVEF in percent
Echo: to measure LVEF in percent
Measured: Baseline- 6 months
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
Measured: Baseline- 6 months
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
Measured: Baseline- monthly- 6 months
Serum creatinine (SCr)
Serum creatinine (SCr) in mg/dL
Measured: Baseline- monthly- 6 months
Lactate concentration
lactate concentration unit in mmol/L
Measured: Baseline - 6 months
Glucometabolic State
Glucometabolic State using HbA1c (unit mmols/mol)
Measured: Baseline - 6 months
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.
Measured: Baseline - 6 months
Rate of hospitalization
The number of hospitalizations within each group will be calculated during the study period.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start9 Dec 2019
- Primary completion9 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Radwa Abdelatif, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708053
- Sponsor's protocol ID
- December-2019
- Status last verified
- Oct 2026
- First submitted
- 9 Jan 2023
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardio-protective Effect of Metformin in Patients Undergoing Elective Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT05708053
- Acronym / sponsor ID
- December-2019
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 9 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin Group | Experimental | Drug: MetforminPatients 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. |
| Comparator | No intervention | –Patients will receive pre-treatment and post treatment standard of care to the procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (age above 18)
- Undergoing elective PCI
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminMetformin 500 mg twice | Drug | Metformin Group |
Primary outcome
Postprocedural myocardial injury
Time frame: 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]
10 secondary outcomes
CK-MB
Time frame: 24 hours post PCI
cTn
Time frame: 24 hours post PCI
LVEF in percent
Time frame: Baseline- 6 months
LVMI in g/m2
Time frame: Baseline- 6 months
GFR
Time frame: Baseline- monthly- 6 months
Serum creatinine (SCr)
Time frame: Baseline- monthly- 6 months
Lactate concentration
Time frame: Baseline - 6 months
Glucometabolic State
Time frame: Baseline - 6 months
Incidence of Cardiovascular Event
Time frame: Baseline - 6 months
Rate of hospitalization
Time frame: through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metformin in people with Elective Percutaneous Coronary Intervention and Ischemic Reperfusion Injury, run by Future University in Egypt at 3 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprocedural myocardial injury (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.