CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 300 enrolled
Drug / intervention
Bendavia (MTP-131) +1 moredrug
Likely dose
Bendavia (MTP-131) 0.05 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01572909
NCT01572909Phase 2Completed

A Phase 2a Trial to Evaluate the Safety, Tolerability and Efficacy of Intravenous MTP-131 on Reperfusion Injury in Patients Undergoing Primary Percutaneous Coronary Intervention and Stenting for ST-segment Elevation Myocardial Infarction Infarction

Stealth BioTherapeutics Inc.·interventional·Posted Apr 6, 2012·Updated Jun 11, 2020

In Brief

A Phase 2 clinical trial evaluating Bendavia (MTP-131) and Placebo for Reperfusion Injury and STEMI. Completed, enrolled 300 participants across 30 sites in 4 countries.

Detailed Summary

The EMBRACE-STEMI trial was a Phase 2a prospective, multicenter, multinational randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, and efficacy of IV administered elamipretide (also known as MTP-131, or Bendavia) on a background of standard-of-care therapy for reduction of reperfusion injury in patients with first time acute, anterior wall ST-segment elevation myocardial infarction (STEMI).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, Hungary, Poland, United States

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 6, 2012
Enrollment StartApr 1, 2012
Primary CompletionNov 1, 2014
Study CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 14.2 years ago

Interventions

Bendavia (MTP-131)drug

0.05 mg/kg/hr

Placebodrug

Identically appearing placebo