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NCT01572909 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Myocardial Effects of MTP-131 for Reducing Reperfusion Injury in Patients With Acute Coronary Events
A Phase 2 study of Reperfusion Injury and STEMI, sponsored by Stealth BioTherapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 300
- Enrollment target
- 20
- Study locations
NCT01572909: Completed Phase 2 study of Reperfusion Injury and STEMI, sponsored by Stealth BioTherapeutics.
NCT01572909 is a Phase 2 study of Reperfusion Injury and STEMI that has completed, run by Stealth BioTherapeutics. The registered enrollment target is 300 participants, below the 815-participant average among 4 other Reperfusion Injury trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01572909, a Phase 2 study of Reperfusion Injury and STEMI, has completed, sponsored by Stealth BioTherapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 300 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
Infarct size as measured by the AUC of serum CK-MB at 24 and 72 hours post-PCI
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Bendavia (MTP-131)
Study Locations (20)
Other
- Universitätsmedizin Berlin, Charité Campus Benjamin Franklin - Berlin
- Staedtische Kliniken Bielefeld - Bielefeld
- Marienhaus Klinikum Eifel - Bitburg
- Universitaetsklinikum Freiburg - Freiburg im Breisgau
- Klinikum Herford - Herford
- Robert-Bosch-Krankenhaus Kardiologie - Stuttgart
- Helios Klinikum Wuppertal, Herzzentrum Elberfeld - Wuppertal
- Gottsegen Gyorgy Orszagos Kardiologiai Intezet - Budapest
- Semmelweis Egyetem Kardiológiai Központ, Városmajor u. 68 - Budapest
- Honvédkórház-Állami Egészségügyi Központ - Budapest
- PTE Klinikai Központ Szívgyógyászati Klinika - Pécs
- Szent György Kórház, II. Belgyógyászati Osztály - Székesfehérvár
- Zala Megyei Kórház, Kardiológiai Osztály, Zrínyi Miklós út 1. - Zalaegerszeg
- Medical University of Bialystok - Bialystok
- SPSK Nr 7 Klaskiego Uniwersytetu Medycznego w Katowicach, Gornoslaskie Centrum Medyczne im. Prof. Leszka Gieca, III Oddzial Kardiologii, Zklad Kardiologii Inwazjnejul, Ziolowa 45-47 - Katowice
- SPSK Nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach, Gornoslaskie Centrum Medyczne im. Prof. Leszaka Gieca, I Oddzial Kardiologii, ul. Ziolowa 45-47 - Katowice
- Wojewodzki Szpital Zespolony w Kielcach, Swietokrzyskie Centrum Kardiologii - Kielce
Florida
- Advanced Medical Research Center - Port Orange
Michigan
- Henry Ford Hospital - Detroit
Nebraska
- Creighton Cardiac Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2012-04 |
| Est. Completion | 2015-02 |
| Phase | Phase 2 |
What the finished NCT01572909 record still lists
NCT01572909 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 815-participant average among 4 other Reperfusion Injury trials with a reported enrollment target (63% lower).
The record links to 2 conditions, with Reperfusion Injury appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01572909 names 20 study sites across 4 states, led by Other, Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT01572909 about?
NCT01572909 is a clinical study titled "Evaluation of Myocardial Effects of MTP-131 for Reducing Reperfusion Injury in Patients With Acute Coronary Events". 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...
What is the current status of trial NCT01572909?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2012-04. Estimated completion is 2015-02.
What conditions does trial NCT01572909 study?
This clinical trial studies the following conditions: Reperfusion Injury, STEMI.
What interventions are being tested in trial NCT01572909?
The interventions under investigation include: Placebo (DRUG), Bendavia (MTP-131) (DRUG).
Who is sponsoring clinical trial NCT01572909?
This trial is sponsored by Stealth BioTherapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01572909 being conducted?
This trial has 20 study locations across Florida, Michigan, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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