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

About this trial

Last updated 3 years ago

Study ID

OPL-0301-201

Status

Withdrawn

Type

Interventional

Phase

Phase 2

Placebo

Yes

Accepting

18 to 90 Years

All Sexes

Trial Timing

Ended 2 years ago

What is this trial about?

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)

What are the participation requirements?

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)