Myocardial Protection of Exenatide in AMI

What Was Tested

In this phase 4 trial, researchers set out to test Exenatide and Amylin (Islet Amyloid Polypeptide).

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

The registry classes the interventions as drug.

More on the Plan

In this proof-of-concept trial, the researchers assessed the effects of acute-phase adjunctive exenatide therapy in patients with STEMI.

Infarct size after STEMI was evaluated by both cardiac magnetic resonance image and cardiac biomarkers compared with standard treatment.

LV function was assessed by conventional and speckle tracking echocardiography.

During 6-month follow up, the safety/tolerability of exenatide and clinical outcomes were also assessed.

Who Took Part

The registry lists 127 actual participants took part.

It was open to people of any sex aged from 20 years up to 79 years.

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

Examples of who could join: Age between 20 and 79 years. Patients presenting with first ST-segment elevation myocardial infarction. Thrombolysis in Myocardial Infarction \[TIMI\] flow grade 0).

The full record lists 3 inclusion and 16 exclusion criteria; among the exclusions: cardiac arrest; ventricular fibrillation; cardiogenic shock.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

Because people in this Exenatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Exenatide group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether Exenatide was given.

Those kept unaware of assignments: participant.

It started in 2009-09 with completion listed for 2011-08.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Infarct size (time frame: 1 month).

It also tracked 3 secondary outcomes, for example Number of Participants with Adverse Events, LV function and Clinical outcomes.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide and Amylin (Islet Amyloid Polypeptide) in 127 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page and the Amylin (Islet Amyloid Polypeptide) compound page, all human trials.