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

Myocardial Infarction Clinical Trial

— RESTORE  

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05327855
• Other study ID #: OPL-0301-201
• Status: Withdrawn
• Phase: Phase 2
• Start date: September 2022
• Est. completion date: November 2024

Study information

• Verified date: February 2023
• Source: Valo Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Ventricular Dysfunction

Intervention

Drug:
• OPL-0301 Dose 1
Pharmaceutical form: Hard gelatin capsule; Route of administration: Oral
• OPL-0301 Dose 2
Pharmaceutical form: Hard gelatin capsule; Route of administration: Oral
• Placebo
Pharmaceutical form: Hard gelatin capsule; Route of administration: Oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Valo Health, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infarct size as determined by cardiac magnetic resonance (CMR) at Day 90	To evaluate the effects of OPL-0301 versus placebo on infarct size in adults with post-myocardial infarction left ventricular dysfunction at day 90	90 days
Secondary	Change in infarct size by cardiac magnetic resonance (CMR) from initial CMR assessment to Day 90	To evaluate the effects of OPL-0301 versus placebo on the change in infarct size in adults with post-myocardial infarction left ventricular dysfunction	Initial to 90 days
Secondary	Adverse events (AEs) and Serious adverse events (SAEs)	To assess the effects of OPL-0301 on safety and tolerability	Baseline to 120 days