Status:
WITHDRAWN
Efficacy and Safety of OPL-0301 Compared to Placebo in Adults With Post-Myocardial Infarction (MI)
Lead Sponsor:
Valo Health, Inc.
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
Study OPL-0301-201 is intended to generate efficacy and safety data of OPL-0301 in participants with post-myocardial infarction (MI) left ventricular dysfunction (LVD)
Detailed Description
OPL-0301 is intended to address the disease state of post-myocardial infarction (MI) left ventricular dysfunction (LVD). MI is a manifestation of atherosclerotic coronary artery disease, the pathogene...
Eligibility Criteria
Inclusion
- Are male or female between 18 and 90 years of age, inclusive, at the time of signing the informed consent
- Are hospitalized with acute ST-Elevated Myocardial Infarction (STEMI), defined based on American Heart Association (AHA)/American College of Cardiology (ACC) criteria
- Have cardiac troponin-I (cTnI), cardiac troponin-T (cTnT) levels ≥10x upper limit of normal (ULN) at least once during the index event of myocardial infarction
Exclusion
- Previous history of documented myocardial infarction
- Previous history of percutaneous coronary intervention (PCI) within 6 months or coronary artery bypass graft surgery (CABG) or valvular heart surgery at any time prior to screening
- Previous history of documented chronic left ventricular dysfunction with ejection fraction (EF) \< 50%
- Previous history of decompensated heart failure
- Previous history of documented specific cardiomyopathy (including but not limited to hypertrophic cardiomyopathy (HCM), amyloid, sarcoid, etc.)
- Previous history of documented arrhythmias
- Are being treated with Sphingosine-1 Phosphate (S1P) modulators (fingolimod, siponimod, ozanimod, ponesimod)
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05327855
Start Date
September 1 2022
End Date
November 1 2024
Last Update
February 21 2023
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