Phase 3
N=380
Metformin to Reduce Heart Failure After Myocardial Infarction
ST Elevation Myocardial Infarction (STEMI) · Coronary Artery Disease · Heart Failure · Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT01217307 ↗Enrolled (actual)
380
Serious AEs
4.5%
Results posted
Jan 2018
Primary outcome: Primary: Improvement in Left Ventricular Ejection Fraction — 53.1; 54.8 % of LVEF
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Metformin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Medical Center Groningen
- Primary completion
- Oct 2013
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 |
— | — |
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.
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). 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.