Trials / Completed
CompletedNCT01217307
Metformin to Reduce Heart Failure After Myocardial Infarction
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.
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 380 (actual)
- Sponsor
- University Medical Center Groningen · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Metformin | Metformin 500mg twice daily during 4 months |
| DRUG | Placebo | Placebo twice daily during 4 months |
Timeline
- Start date
- 2011-01-01
- Primary completion
- 2013-10-01
- Completion
- 2015-10-01
- First posted
- 2010-10-08
- Last updated
- 2018-01-30
- Results posted
- 2018-01-30
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT01217307. Inclusion in this directory is not an endorsement.