Clinical trial NCT05327855: Efficacy and Safety of OPL-0301 Compared to Placebo in Adults With Post-Myocardial Infarction (MI)
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Multiple-arm, Parallel-group, Adaptive Study to Investigate the Efficacy and Safety of OPL-0301 in Patients With Post-myocardial Infarction Left Ventricular Dysfunction (RESTORE)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Myocardial Infarction
Keywords: heart attack
acute ischemic heart disease
acute coronary syndrome
ST-Elevated Myocardial Infarction
left ventricular dysfunction
Lead sponsor: Valo Health, Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a Phase 2, multicenter, randomized, placebo-controlled, multiple-arm, adaptive study investigating the safety, pharmacokinetics, and potential efficacy of OPL-0301, along with standard of care, in post-myocardial infarction (MI) participants with left ventricular dysfunction (LVD).

Participants will have been admitted to the hospital for acute MI and treated with primary percutaneous coronary intervention (PPCI) before entering the study. A fixed oral dose will be administered once daily, according to the blinded treatment assignment.
Primary purpose: TREATMENT

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 pathogenesis of which is closely associated with vascular and endothelial dysfunction, and inflammation. Acute MI leads to acute LVD, which often persists, leading to poor cardiovascular outcomes. The therapeutic hypothesis is that these effects mediated by Sphingosine-1 Phosphate 1 (S1P1) receptor agonism with OPL-0301 will reduce infarct size and benefit post-MI left ventricular function, thereby supporting improved cardiovascular outcomes in this patient population.

Eligibility 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)

Primary outcomes:
measure: Infarct size as determined by cardiac magnetic resonance (CMR) at Day 90
timeFrame: 90 days
Secondary outcomes:
measure: Change in infarct size by cardiac magnetic resonance (CMR) from initial CMR assessment to Day 90
timeFrame: Initial to 90 days
measure: Adverse events (AEs) and Serious adverse events (SAEs)
timeFrame: Baseline to 120 days
Other outcomes:
Locations:
Study officials:
affiliation: Valo Health, Inc.
name: Victor Shi, M.D.
role: STUDY_DIRECTOR
References: