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OPL-0301 Dose 1 for Heart Attack (RESTORE Trial)

Phase 2
Waitlist Available
Research Sponsored by Valo Health, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 120 days
Awards & highlights

RESTORE Trial Summary

This trial is testing a new drug, OPL-0301, to see if it is effective and safe in treating people with post-myocardial infarction left ventricular dysfunction.

Eligible Conditions
  • Heart Attack

RESTORE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 120 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 120 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Infarct size as determined by cardiac magnetic resonance (CMR) at Day 90
Secondary outcome measures
Adverse events (AEs) and Serious adverse events (SAEs)
Change in infarct size by cardiac magnetic resonance (CMR) from initial CMR assessment to Day 90

RESTORE Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: OPL-0301 Dose 2Experimental Treatment1 Intervention
Participants are randomized to OPL-0301 Dose 2 administered once daily for 90 days
Group II: OPL-0301 Dose 1Experimental Treatment1 Intervention
Participants are randomized to OPL-0301 Dose 1 administered once daily for 90 days
Group III: PlaceboPlacebo Group1 Intervention
Participants are randomized to matching placebo administered once daily for 90 days

Find a Location

Who is running the clinical trial?

Valo Health, Inc.Lead Sponsor
1 Previous Clinical Trials
107 Total Patients Enrolled
Victor Shi, M.D.Study DirectorValo Health, Inc.
1 Previous Clinical Trials
107 Total Patients Enrolled
Philip D Yin, M.D., Ph.D.Study DirectorValo Health, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What type of participants is best suited for this research endeavor?

"In order to gain entrance into this medical trial, patients must have suffered from a myocardial infarction and be within the ages of 18-90. A total of 174 participants are being recruited for the study."

Answered by AI

Is enrollment still open for this research endeavor?

"According to clinicaltrials.gov, this trial is not presently accepting patients. The initial posting was dated on September 1st 2022 and the last update occured August 31st of that same year. Although this particular medical study isn't recruiting at present, 389 other trials are actively seeking participants."

Answered by AI

Is the age bracket for this clinical experiment restricted to individuals under sixty years of age?

"The trial parameters require that participants of this study must be at least 18 and no older than 90 years old."

Answered by AI

Has the initial dosage of OPL-0301 been officially sanctioned by the Food and Drug Administration?

"OPL-0301 Dose 1 was assigned a score of 2 due to the lack of evidence demonstrating efficacy, despite existing data validating its safety."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of OPL-0301 Compared to Placebo in Adults With Post-Myocardial Infarction (MI)
2022. "Efficacy and Safety of OPL-0301 Compared to Placebo in Adults With Post-Myocardial Infarction (MI)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05327855.
~0 spots leftby Aug 2024
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