Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05327855
Other study ID # OPL-0301-201
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
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
Health authority
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Status Withdrawn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)

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT06013813 - Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI N/A
Completed NCT04507529 - Peer-mentor Support for Older Vulnerable Myocardial Infarction Patients N/A
Recruiting NCT06066970 - Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery
Recruiting NCT03620266 - Effects of Bilberry and Oat Intake After Type 2 Diabetes and/or MI N/A
Completed NCT04097912 - Study to Gather Information to What Extent Patients Follow the Treatment Regimen of Low-dose Aspirin for Primary and Secondary Prevention of Diseases of the Heart and Blood Vessels
Completed NCT04153006 - Comparison of Fingerstick Versus Venous Sample for Troponin I.
Completed NCT03668587 - Feasibility and Security of a Rapid Rule-out and rule-in Troponin Protocol in the Management of NSTEMI in an Emergency Departement
Recruiting NCT01218776 - International Survey of Acute Coronary Syndromes in Transitional Countries
Completed NCT03076801 - Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease? N/A
Recruiting NCT05371470 - Voice Analysis Technology to Detect and Manage Depression and Anxiety in Cardiac Rehabilitation N/A
Recruiting NCT04562272 - Attenuation of Post-infarct LV Remodeling by Mechanical Unloading Using Impella-CP N/A
Completed NCT04584645 - A Digital Flu Intervention for People With Cardiovascular Conditions N/A
Active, not recruiting NCT04475380 - Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
Not yet recruiting NCT06007950 - Time-restricted Eating Study (TRES): Impacts on Anthropometric, Cardiometabolic and Cardiovascular Health N/A
Recruiting NCT02876952 - High Intensity Aerobic Interval Training With Mediterranean Diet Recommendations in Post-Myocardial Infarct Patients N/A
Completed NCT02917213 - Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction
Completed NCT02711631 - Feasibility and Effectiveness of Remote Virtual Reality-Based Cardiac Rehabilitation N/A
Completed NCT02552407 - Thrombectomy in ST Elevation Myocardial Infarction, an Individual Patient Meta-analysis N/A
Completed NCT02382731 - Interventions to Support Long-Term Adherence aNd Decrease Cardiovascular Events Post-Myocardial Infarction N/A
Completed NCT02305602 - A Study of VentriGel in Post-MI Patients Phase 1