Evaluation of Myocardial Effects of MTP-131 for Reducing Reperfusion Injury in Patients With Acute Coronary Events

What Was Tested

This registered phase 2 trial tested SS-31 (Elamipretide).

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

The registry classes the interventions as drug.

More on the Plan

The infusion began at least 15 minutes but no more than 1 hour prior to the anticipated reperfusion event and continued through approximately 1 hour following re-establishment of blood flow through the culprit vessel.

The analyses of cardiac MRI data were performed for both the primary endpoint population and also in all patients who had adequate Day 4/Day 30 cardiac MRI studies.

After completion of the percutaneous coronary intervention (PCI) and stenting, patients received standard medical treatment.

Who Took Part

Enrollment: 300 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

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

Examples of who could join: Age ≥18 and \<85 years. The patient presents with first-time acute, anterior wall STEMI scheduled to undergo primary PCI and stenting. The patient has symptoms of cardiac ischemia of ≥10 minutes. Written informed consent obtained that strictly adheres to the written guidelines from the local Institutional Review Board (IRB)/ Ethical Committee (EC).

The full record lists 9 inclusion and 15 exclusion criteria; among the exclusions: cardiogenic shock or maximal systolic blood pressure (bp) \<80 mm hg after fluid and/or vasopressor resuscitation on at least two consecutive readings; ongoing vasopressor support; uncontrolled hypertension defined as a systolic bp \>180 mm hg or a diastolic bp \>110 mm hg on at least two consecutive readings.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got SS-31 (Elamipretide) and who got the comparison, which limits bias.

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

As a double-blind SS-31 (Elamipretide) study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2012-04 with completion listed for 2014-11.

It ran at 30 sites in Poland (14), Germany (7), Hungary (6) and United States (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area Under the Curve (AUC) of Serum Creatine Kinase Isoenzyme Type Muscle-brain (CK-MB) (time frame: The initial 24 and 72 hours post-percutaneous coronary intervention (PCI)).

It also tracked 19 secondary outcomes, for example AUC of Troponin 1 Enzyme, Ratio of Volume of Infarcted Myocardium to Left Ventricular Mass, Thrombosis in Myocardial Infarction (TIMI) Perfusion Grade Flow at Completion of PCI, Corrected TIMI Frame Count, ST-Segmented Elevation From Pre-PCI to 24 Hours Post-PCI and Presence of ST-Segmented Resolution and Change in Serum Creatinine From Baseline.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of SS-31 (Elamipretide) in 300 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the SS-31 (Elamipretide) compound page, all human trials.