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

Primary Purpose

Myocardial Infarction

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
OPL-0301 Dose 1
OPL-0301 Dose 2
Placebo
Sponsored by
Valo Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring heart attack, acute ischemic heart disease, acute coronary syndrome, ST-Elevated Myocardial Infarction, left ventricular dysfunction

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    OPL-0301 Dose 1

    OPL-0301 Dose 2

    Placebo

    Arm Description

    Participants are randomized to OPL-0301 Dose 1 administered once daily for 90 days

    Participants are randomized to OPL-0301 Dose 2 administered once daily for 90 days

    Participants are randomized to matching placebo administered once daily for 90 days

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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
    Adverse events (AEs) and Serious adverse events (SAEs)
    To assess the effects of OPL-0301 on safety and tolerability

    Full Information

    First Posted
    December 22, 2021
    Last Updated
    February 16, 2023
    Sponsor
    Valo Health, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05327855
    Brief Title
    Efficacy and Safety of OPL-0301 Compared to Placebo in Adults With Post-Myocardial Infarction (MI)
    Acronym
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Withdrawn based on business decision, no participants enrolled
    Study Start Date
    September 2022 (Anticipated)
    Primary Completion Date
    August 2024 (Anticipated)
    Study Completion Date
    November 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Valo Health, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myocardial Infarction
    Keywords
    heart attack, acute ischemic heart disease, acute coronary syndrome, ST-Elevated Myocardial Infarction, left ventricular dysfunction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    OPL-0301 Dose 1
    Arm Type
    Experimental
    Arm Description
    Participants are randomized to OPL-0301 Dose 1 administered once daily for 90 days
    Arm Title
    OPL-0301 Dose 2
    Arm Type
    Experimental
    Arm Description
    Participants are randomized to OPL-0301 Dose 2 administered once daily for 90 days
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants are randomized to matching placebo administered once daily for 90 days
    Intervention Type
    Drug
    Intervention Name(s)
    OPL-0301 Dose 1
    Intervention Description
    Pharmaceutical form: Hard gelatin capsule; Route of administration: Oral
    Intervention Type
    Drug
    Intervention Name(s)
    OPL-0301 Dose 2
    Intervention Description
    Pharmaceutical form: Hard gelatin capsule; Route of administration: Oral
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Pharmaceutical form: Hard gelatin capsule; Route of administration: Oral
    Primary Outcome Measure Information:
    Title
    Infarct size as determined by cardiac magnetic resonance (CMR) at Day 90
    Description
    To evaluate the effects of OPL-0301 versus placebo on infarct size in adults with post-myocardial infarction left ventricular dysfunction at day 90
    Time Frame
    90 days
    Secondary Outcome Measure Information:
    Title
    Change in infarct size by cardiac magnetic resonance (CMR) from initial CMR assessment to Day 90
    Description
    To evaluate the effects of OPL-0301 versus placebo on the change in infarct size in adults with post-myocardial infarction left ventricular dysfunction
    Time Frame
    Initial to 90 days
    Title
    Adverse events (AEs) and Serious adverse events (SAEs)
    Description
    To assess the effects of OPL-0301 on safety and tolerability
    Time Frame
    Baseline to 120 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Victor Shi, M.D.
    Organizational Affiliation
    Valo Health, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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