Phase 3
Completed N=380
Metformin to Reduce Heart Failure After Myocardial Infarction
Source: ClinicalTrials.gov NCT01217307 ↗Enrolled (actual)
380
Serious AEs
4.5%
Results posted
Jan 2018
Primary outcomePrimary: Improvement in Left Ventricular Ejection Fraction — 53.1; 54.8 % of LVEF
◆ Published Evidence
Established
42citations · ~8 / year
Association of Circulating Ketone Bodies With Functional Outcomes After ST-Segment Elevation Myocardial Infarction.
Summary
The investigators will evaluate the effect of metformin therapy during 4 months in non-diabetic patients following ST-elevation myocardial infarction on left ventricular ejection fraction as measured with cardiac magnetic resonance imaging, compared to placebo.
Linked Publications (5)
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Association of Circulating Ketone Bodies With Functional Outcomes After ST-Segment Elevation Myocardial Infarction.
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Two-year follow-up of 4 months metformin treatment vs. placebo in ST-elevation myocardial infarction: data from the GIPS-III RCT.
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Effect of Metformin on Metabolites and Relation With Myocardial Infarct Size and Left Ventricular Ejection Fraction After Myocardial Infarction.
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Effect of Metformin Treatment on Lipoprotein Subfractions in Non-Diabetic Patients with Acute Myocardial Infarction: A Glycometabolic Intervention as Adjunct to Primary Coronary Intervention in ST Elevation Myocardial Infarction (GIPS-III) Trial.
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Predictors of adverse diastolic remodeling in non-diabetic patients presenting with ST-elevation myocardial infarction.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Improvement in Left Ventricular Ejection Fraction |
53.1; 54.8 | — |
| SECONDARY the Incidence of a Cardiovascular Event |
— | — |
| SECONDARY Markers of Heart Failure and Glycometabolic State |
— | — |
| SECONDARY Myocardial Infarct Size and Transmural Extent of Infarction as Measured With Cardiac Magnetic Resonance Imaging |
— | — |
| SECONDARY Diastolic Function |
— | — |
| SECONDARY Glycometabolic State |
— | — |
| SECONDARY Cardiac MRI After 4 Months, Per Protocol Analysis |
— | — |
Eligibility Criteria
Inclusion Criteria
- The diagnosis acute MI defined by chest pain suggestive for myocardial ischemia for at least 30 minutes, the time from onset of the symptoms less than 12 hours before hospital admission, and an ECG recording with ST- segment elevation of more than 0.1 mV in 2 or more leads.
- Successful primary PCI (post-procedural TIMI 2/3);
- At least one stent sized ≥ 3.0 mm;
- Eligible for 3T CMR imaging;
- Verbal followed by written informed consent.
Exclusion Criteria
- rescue PCI after thrombolytic therapy;
- need for emergency coronary artery bypass grafting;
- creatinin >177 μmol/L measured pre-PCI;
- Younger than 18 years;
- Mechanical ventilation;
- Diabetes;
- Prior myocardial infarction;
- Contra-indication to metformin (see safety);
- The existence of a life-threatening disease with a life-expectancy of less than 6 months.
Data sourced from ClinicalTrials.gov (NCT01217307) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.