Myocardial InfarctionPhase 2RESTORENCT05327855
Efficacy and Safety of OPL-0301 Compared to Placebo in Adults With Post-Myocardial Infarction (MI)
A Phase 2 study testing OPL-0301 Dose 1 and OPL-0301 Dose 2 in people with Myocardial Infarction, run by Valo Health, Inc..
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) Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- OPL-0301 Dose 1 and OPL-0301 Dose 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Nov 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
About this study
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 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)
Read the 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.
- Conditions
- Myocardial Infarction
- Being tested
- OPL-0301 Dose 1, OPL-0301 Dose 2, Placebo
- Keywords
- heart attack, acute ischemic heart disease, acute coronary syndrome, ST-Elevated Myocardial Infarction, left ventricular dysfunction
- Medical subject headings
- Myocardial Infarction, Acute Coronary Syndrome, ST Elevation Myocardial Infarction, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPL-0301 Dose 1Drug
Pharmaceutical form: Hard gelatin capsule; Route of administration: Oral
OPL-0301 Dose 2Drug
Pharmaceutical form: Hard gelatin capsule; Route of administration: Oral
PlaceboDrug
Pharmaceutical form: Hard gelatin capsule; Route of administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| OPL-0301 Dose 1 | Experimental | Participants are randomized to OPL-0301 Dose 1 administered once daily for 90 days Receives: Drug: OPL-0301 Dose 1 |
| OPL-0301 Dose 2 | Experimental | Participants are randomized to OPL-0301 Dose 2 administered once daily for 90 days Receives: Drug: OPL-0301 Dose 2 |
| Placebo | Placebo comparator | Participants are randomized to matching placebo administered once daily for 90 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days
Secondary outcomes (2)
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
Measured: Initial to 90 days
Adverse events (AEs) and Serious adverse events (SAEs)
To assess the effects of OPL-0301 on safety and tolerability
Measured: Baseline to 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study startSep 2022 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionNov 2024 (estimated)
Why it stopped: Withdrawn based on business decision, no participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valo Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Victor Shi, M.D., Study director, Valo Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327855
- Sponsor's protocol ID
- OPL-0301-201
- Acronym
- RESTORE
- Status last verified
- Feb 2023
- First submitted
- 22 Dec 2021
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05327855
- Acronym / sponsor ID
- RESTORE / OPL-0301-201
- Conditions
- Myocardial Infarction
- Keywords
- heart attack, acute ischemic heart disease, acute coronary syndrome, ST-Elevated Myocardial Infarction, left ventricular dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn based on business decision, no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Valo Health, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2022 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| OPL-0301 Dose 1 | Experimental | Drug: OPL-0301 Dose 1Participants are randomized to OPL-0301 Dose 1 administered once daily for 90 days |
| OPL-0301 Dose 2 | Experimental | Drug: OPL-0301 Dose 2Participants are randomized to OPL-0301 Dose 2 administered once daily for 90 days |
| Placebo | Placebo comparator | Drug: PlaceboParticipants are randomized to matching placebo administered once daily for 90 days |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPL-0301 Dose 1Pharmaceutical form: Hard gelatin capsule; Route of administration: Oral | Drug | OPL-0301 Dose 1 |
| OPL-0301 Dose 2Pharmaceutical form: Hard gelatin capsule; Route of administration: Oral | Drug | OPL-0301 Dose 2 |
| PlaceboPharmaceutical form: Hard gelatin capsule; Route of administration: Oral | Drug | Placebo |
Primary outcome
Infarct size as determined by cardiac magnetic resonance (CMR) at Day 90
Time frame: 90 days
To evaluate the effects of OPL-0301 versus placebo on infarct size in adults with post-myocardial infarction left ventricular dysfunction at day 90
2 secondary outcomes
Change in infarct size by cardiac magnetic resonance (CMR) from initial CMR assessment to Day 90
Time frame: Initial to 90 days
Adverse events (AEs) and Serious adverse events (SAEs)
Time frame: Baseline to 120 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor Shi, M.D. study director
Valo Health, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OPL-0301 Dose 1 and OPL-0301 Dose 2 in people with Myocardial Infarction, run by Valo Health, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infarct size as determined by cardiac magnetic resonance (CMR) at Day 90 (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.