Overview

This trial is active, not recruiting.

Conditions st elevation myocardial infarction (stemi), coronary artery disease, heart failure, diabetes
Treatments metformin, placebo
Phase phase 2/phase 3
Sponsor University Medical Centre Groningen
Collaborator ZonMw: The Netherlands Organisation for Health Research and Development
Start date January 2011
End date October 2013
Trial size 380 participants
Trial identifier NCT01217307, GIPS-III 2010B257

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
metformin 500mg twice daily during 4 months
metformin Glucophage
Metformin 500mg twice daily during 4 months
(Placebo Comparator)
Placebo twice daily during 4 months
placebo
Placebo twice daily during 4 months

Primary Outcomes

Measure
Improvement in left ventricular ejection fraction
time frame: 4 months

Secondary Outcomes

Measure
the incidence of a cardiovascular event
time frame: 4 months and longterm follow-up
markers of heart failure and glycometabolic state
time frame: 4 months and longterm follow-up
Myocardial infarct size and transmural extent of infarction as measured with cardiac magnetic resonance imaging
time frame: 4 months after hospitalization
diastolic function
time frame: 4 months
glycometabolic state
time frame: 4 months and long-term follow-up
Cardiac MRI after 4 months, per protocol analysis
time frame: 4 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Metabolic Modulation With Metformin to Reduce Heart Failure After Acute Myocardial Infarction: Glycometabolic Intervention as Adjunct to Primary Coronary Intervention in ST Elevation Myocardial Infarction (GIPS-III): a Randomized Controlled Trial.
Principal investigator Iwan CC van der Horst, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by University Medical Centre Groningen.