Efficacy and Safety of OPL-0301 Compared to Placebo in Adults With Post-Myocardial Infarction (MI)

• Status: Not yet recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Valo Health, Inc.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)