Metformin to Reduce Heart Failure After Myocardial Infarction (GIPS-III)

University Medical Center Groningen (UMCG)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Coronary Artery Disease; ST Elevation Myocardial Infarction (STEMI); Diabetes; Heart Failure

Treatments: Drug: Metformin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01217307

GIPS-III 2010B257

Details and patient eligibility

About

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.

Full description

In this trial, the investigators will evaluate the effect of metformin therapy following ST-elevation myocardial infarction (STEMI) in a total of 380 non-diabetic patients. This trial is a randomized, double blind, controlled trial. The intervention, which consist of metformin 500mg twice daily or placebo twice daily, will commence within three hours after the percutaneous coronary intervention, and will be continued for 4 months. The primary endpoint is the difference between the two intervention groups (metformin vs placebo) in left ventricular ejection fraction, as measured with magnetic resonance imaging after 4 months. The investigators hypothesize that metformin therapy results in a significantly higher ejection fraction in this population.

Enrollment: 380 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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380 participants in 2 patient groups, including a placebo group

Metformin

Experimental group

Description:

metformin 500mg twice daily during 4 months

Treatment:

Drug: Metformin

Placebo

Placebo Comparator group

Description:

Placebo twice daily during 4 months

Treatment:

Drug: Placebo