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RECRUITING Phase 3

Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS

NCT05918861 · View on ClinicalTrials.gov ↗

Study Summary

This is a placebo-controlled, randomized, double-blind, parallel group, phase 3 multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects will provide informed consent before any study-specific procedures are performed. A separate informed consent will be allowed for an initial pre-screening genetic testing. Subjects meeting the AA genotype will then consent to the full study and confirmatory genetic testing as required. Subject enrollment may begin in the hospital and will continue following release from the hospital or may begin following release from hospital. Screening procedures may be performed at the time of the index ACS event or anytime thereafter, with the condition that randomization must occur within the mandated window (up to12 weeks after the index event). Subjects will be assessed based on their medical history. Those who are likely to qualify will undergo Genotype Assay testing to evaluate genetic determination for the presence of AA genotype.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Dalcetrapib

Study Locations (20)

California

  • Research Site — Garden Grove
  • Research Site — Huntington Beach
  • Research Site — La Jolla
  • Research Site — Long Beach
  • Research Site — Los Angeles
  • Research Site — Newport Beach
  • Research Site — Newport Beach
  • Research Site — San Francisco
  • Research Site — Santa Barbara
  • Research Site — Stanford
  • Research Site — Torrance

Alabama

  • Research Site — Alexander City
  • Research Site — Birmingham
  • Research Site — Fairhope
  • Research Site — Huntsville
  • Research Site — Mobile

Arizona

  • Research Site — Scottsdale
  • Research Site — Tucson

Arkansas

  • Research Site — Jonesboro
  • Research Site — North Little Rock

Trial Details

FieldValue
Enrollment Target 2,000 participants
Start Date 2023-10-03
Est. Completion 2027-08
Phase Phase 3

Sponsor

DalCor Pharmaceuticals

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05918861

The ClinicalTrials.gov registry entry for NCT05918861 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is DalCor Pharmaceuticals, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Acute Coronary Syndrome appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05918861 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Alabama, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05918861 about?

NCT05918861 is a clinical study titled "Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS". This is a placebo-controlled, randomized, double-blind, parallel group, phase 3 multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects will provide informed consent before any study-specific procedures are performed. A separate informed consent...

What is the current status of trial NCT05918861?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 2,000 participants. The study started on 2023-10-03. Estimated completion is 2027-08.

What conditions does trial NCT05918861 study?

This clinical trial studies the following conditions: Acute Coronary Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05918861?

The interventions under investigation include: Placebo (DRUG), Dalcetrapib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05918861?

This trial is sponsored by DalCor Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05918861 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial