COMBinAtion Therapy in Myocardial Infarction: The COMBAT-MI Trial

What Was Tested

This registered phase 3 trial tested Exenatide.

It had four arms (groups): Remote Ischemic Conditioning (active comparator), Combined treatment (active comparator), Placebo (placebo comparator) and Exenatide (active comparator).

Remote Ischemic Conditioning + placebo.

Remote Ischemic Conditioning + exenatide.

Sham Remote Ischemic Conditioning + placebo.

The registry classes the interventions as drug and other.

More on the Plan

COMBAT-MI is an investigator-driven, randomized, double-blind and placebo-controlled clinical trial aimed at evaluating the effect of Remote Ischemic Conditioning and exenatide, alone and in combination, on Myocardial Infarct size in 428 STEMI patients (107 per group) (ST segment elevation myocardial infarction).

Patients with TIMI (Thrombolysis in Myocardial Infarction) flow grade \> 1 will be excluded.

The study has a 2 x 2 factorial design (Remote Ischemic Conditioning , Exenatide, both or neither).

The primary end-point will be Myocardial Infarct size measured by Cardiac Magnetic Resonance Imaging (CMRI) performed 3 - 7 days after primary Percutaneous Coronary Intervention (pPCI) (expressed as % of left ventricular (LV) mass).

Who Took Part

Enrollment: 378 actual participants took part.

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: Men or women ≥18 years of age. Patients presenting within 6 hours of chest pain.

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: known hypersensitivity to exenatide or any of the excipients; assumed life expectancy \< 1 year e.g. due to non-cardiac disease; pregnant women.

How the Study Was Run

It was run as a randomized, parallel-group and double-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.

Neither the participants nor the staff measuring them knew who was on Exenatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2016-03 with completion listed for 2019-08.

It ran at 6 sites in Spain (6).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Myocardial Infarct Size (time frame: 3-7 days after pPCI).

It also tracked 6 secondary outcomes, for example Myocardial salvage index, Transmurality index, Ventricular volumes, Microvascular obstruction, Markers of successful reperfusion and Major adverse cardiac events (MACE).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide in 378 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, all human trials.