Exenatide for Myocardial Protection During Reperfusion Study

What Was Tested

In this phase 2 trial, researchers set out to test Exenatide.

This study aims to assess the effect of exenatide on myocardial injury in patients undergoing emergent percutaneous coronary intervention (PCI) for ST segment elevation myocardial infarction or heart attack (STEMI).

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

O Placebo bolus over 30 min followed by placebo infusion at 'Rate 1' for 1.5 h, followed by 'Rate 2' for 22 hours\*.

The registry classes the interventions as drug.

More on the Plan

This is a Phase II randomized, double-blind, placebo-controlled study of patients with STEMI.

Those who agree to participate will be immediately randomized to one of two groups: a 24-h infusion of exenatide; or a 24 h infusion of placebo.

This study will serve as safety evaluation study as well as a pilot for a larger multicentre trial powered for clinical outcomes.

Who Took Part

The registry lists 198 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Antegrade TIMI 0 or 1 prior to PCI in the infarct-related artery. Age ≥18 years.

The full record lists 3 inclusion and 16 exclusion criteria; among the exclusions: diabetes mellitus requiring insulin therapy; diabetic ketoacidosis; coronary anatomy warranting emergent coronary artery bypass graft surgery.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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.

As a double-blind Exenatide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2014-02 with completion listed for 2017-07.

It ran at 10 sites in Canada (10).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Ratio of final infarct size at 3 months over area at risk at 72 hours post randomization (using cMRI) (time frame: 3 months).

It also tracked 31 secondary outcomes, for example Left ventricular global and regional LV systolic ejection fraction, Left ventricular global and regional LV systolic ejection fraction, Left ventricular volume, Left ventricular volume, Infarct size/area of risk (measured by cMRI) and Myocardial enzyme levels (troponin I and CK-MB).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Exenatide in 198 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.