Effect of Additional Treatment With EXenatide in Patients With an Acute Myocardial Infarction (the EXAMI Trial)

What Was Tested

This registered phase 3 trial tested Exenatide.

Myocardial infarction (MI) causes loss of myocytes and may lead to loss of ventricular function, morbidity and mortality.

Reperfusion limits myocardial ischaemic necrosis, but also induces inflammation, oxidative stress and calcium overload: a process referred to as reperfusion injury leading to necrosis and apotosis.

It had two arms (groups): Exenatide (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 40 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: \>18 and \< 80 years of age. First myocardial infarction. ST elevation of more than one mm in at least 2 separate leads on the electrocardiogram (ECG). Delay between onset of sustained chestpain and PCI \< 6 hours.

The full record lists 4 inclusion and 27 exclusion criteria; among the exclusions: cardiac rhythm is other than normal sinus rhythm; patient in killip class 3 or 4 of heart failure; cardiogenic shock defined as sustained systolic blood pressure ≤ 80mmhg despite fluid hydration.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

In this single-blind Exenatide study one party knew the assignments and the other did not.

It started in 2009-11.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 9 secondary outcomes, for example Regional myocardial function based on a MRI segmental analysis at 1 weeek and at 4 months post myocardial infarction, Regional myocardial function assessed by 2D and 3D echocardiography at 1 week and at 4 months post myocardial infarction, Global left ventricular EF, LVESV, LVEDV at 1 week and at 4 months post myocardial infarction measured by 2D and 3D echocardiography, Angiographic parameters as Trombolysis In Myocardial Infarction (TIMI) frame count and TIMI blush grade after PCI, Side effects of exenatide and Serum-glucose levels during the first 72 hours.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide in 40 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page, all human trials.