EMBRACE STEMI study: 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
Abstract
AIMS: Among patients with ST-elevation myocardial infarction (STEMI), reperfusion injury contributes to additional myocardial damage. MTP-131 is a cell-permeable peptide that preserves the integrity of cardiolipin, enhances mitochondrial energetics, and improves myocyte survival during reperfusion. METHODS AND RESULTS: EMBRACE STEMI is a multicentre, randomized, double-blind Phase 2a trial that evaluated the efficacy and safety of MTP-131 vs. placebo infused at a rate of 0.05 mg/kg/h for 1 h among first-time anterior STEMI subjects undergoing primary percutaneous coronary intervention (PCI) for a proximal or mid left anterior descending (LAD) artery occlusion. Administration of MTP-131 was not associated with a significant reduction in the primary endpoint, infarct size by creatine kinase-myocardial band (CK-MB) area under the curve (AUC) over 72 h (5785 ± 426 ng h/mL in placebo vs. 5570 ± 486 ng h/mL in MTP-131; ITALIC! P = NS). MTP-131 was not associated with an improvement in pre-specified magnetic resonance imaging, angiographic, electrocardiographic, or clinical outcomes. CONCLUSION: Among subjects with first-time anterior STEMI due to a proximal or mid LAD lesion who undergo successful PCI, administration of MTP-131 was safe and well tolerated. Treatment with MTP-131 was not associated with a decrease in myocardial infarct size as assessed by AUC0-72 of CK-MB.
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Phase I clinical trials established that SS-31 was safe and well tolerated.
“Phase I clinical trials established that the molecule was safe and well tolerated (360).”
From Sources of Vascular Nitric Oxide and Reactive Oxygen Species and Their Regulation (2019) · cites this paper as [360]
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- Authors
- Gibson, C. M., Giugliano, R. P., Kloner, R. A., Bode, C., Tendera, M., Jánosi, A., Merkely, B., Godlewski, J., Halaby, R., Korjian, S., Daaboul, Y., Chakrabarti, A. K., Spielman, K., Neal, B. J., & Weaver, W. D.
- Affiliations
- Beth Israel Deaconess Medical Center (US)
- Brigham and Women's Hospital (US)
- University of Southern California (US)
- University of Freiburg (DE)
- Gottsegen National Cardiovascular Center (HU)
- John Paul II Hospital (PL)
- Harvard University (US)
- Eastern Virginia Medical School (US)
- Henry Ford Hospital (US)
- Corresponding author
- Gibson, C. Michael
- ORCID
- Venue
- European Heart Journal
- Publisher
- Oxford University Press (OUP)
- Published
- 2015-11-19
- Volume
- 37
- Issue
- 16
- Pages
- 1296.1-1303
- ISSN
- 0195-668X (ISSN-L)
- 1522-9645
- OpenAlex
- W2176701303
- Cited by
- 162
- References
- 36
- Citations by year
- 2026: 9 · 2025: 12 · 2024: 15 · 2023: 12 · 2022: 19 · 2021: 9 · 2020: 19 · 2019: 13 · 2018: 17 · 2017: 19 · 2016: 18
- FWCI
- 14.28
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- European Heart Journal (publishedVersion)
- PubMed (publishedVersion)
- HighWire Press Open Archive (submittedVersion)
- Topics
- Health Sciences › Medicine › Pathology and Forensic Medicine › Cardiac Ischemia and Reperfusion
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Acute Myocardial Infarction Research
- Health Sciences › Medicine › Surgery › Coronary Interventions and Diagnostics
- Keywords
- ST-elevation myocardial infarction, ischemia-reperfusion injury, primary percutaneous coronary intervention, cell-permeable peptide, cardiolipin, mitochondrial bioenergetics, myocardial infarct size, CK-MB, left anterior descending artery occlusion, drug safety and tolerability
- MeSH terms
- ST Elevation Myocardial Infarction, Double-Blind Method, Humans, Oligopeptides, Percutaneous Coronary Intervention
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