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

NCT05918861
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Recruiting
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Participants
2,000
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Lead sponsor
DalCor Pharmaceuticals
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Start date
2023-10-03
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Number of sites
231
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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.
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Acronym
dal-GenE-2
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Short title
Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS
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Official title
Phase III, Double-blind, Randomized Placebo-controlled Study to Evaluate the Effects of Dalcetrapib on Cardiovascular (CV) Risk in a Genetically Defined Population With a Recent Acute Coronary Syndrome (ACS)
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2027-08-01
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First posted
2023-06-26
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Registry last updated
2026-06-22
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Primary completion date
2027-08-01
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Start date
2023-10-03
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Participants
2,000
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Participant count basis
Estimated
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Planned participants
2,000
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Protocol amendments
4
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Number of sites
231
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
DalCor Pharmaceuticals
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05918861
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ClinicalTrials.gov ID
NCT05918861
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masking description
With the exception of the statistician to the DSMB and the DSMB all other individuals will remain blinded until the final analysis of the primary study parameter.
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Time to first occurrence of any fatal or non-fatal myocardial infarction (MI)

    Timeframe: Average of 30 months from randomization

    Time to patients experiencing major cardiovascular events

  1. The composite of all-cause death, resuscitated cardiac arrest, non-fatal MI and non-fatal stroke

    Timeframe: Average of 30 months from randomization

    Time to patients experiencing major cardiovascular events

  2. Composite of all-cause death, resuscitated cardiac arrest, non-fatal MI and non-fatal stroke

    Timeframe: Average of 30 months from randomization

    Time to patients experiencing first and recurrent occurrences

  3. Fatal and non-fatal MI

    Timeframe: Average of 30 months from randomization

    Time to patients experiencing first and recurrent occurrences

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
45 Years
Healthy volunteers
No

  • Subjects with the appropriate genetic background and recently hospitalized for ACS (up to 3 months following the index event), will be enrolled in this trial.
  • Both male and female subjects age 45 years and over at screening visit (V1)
  • AA genotype at variant gene as determined by Genotype Assay Test, conducted at a designated investigational testing site (ITS)
  • Clinically stable, ie, free of ischemic symptoms at rest or with minimal exertion for at least 1 week prior to randomization
  • Prior to randomization, subjects must have evidence of guidelines-based management of LDL-C, at a minimum to include medical and dietary treatment.
  • Randomization within 3 months of the index ACS event

  • Females who are pregnant (negative urine pregnancy test required for all women of child-bearing potential at Visit 2, Day 0) or breast-feeding
  • Women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for >12 months) who are not using at least one highly effective method of contraception.
  • New York Heart Association (NYHA) Class III or IV heart failure
  • Index ACS event presumed due to uncontrolled hypertension
  • Systolic blood pressure (BP) >180 mmHg and/or diastolic blood pressure >110 mmHg at the time of randomization despite anti-hypertensive therapy
  • Subjects with clinically apparent liver disease, eg, jaundice, cholestasis, hepatic synthetic impairment, active hepatitis or last known ALT or AST level >3 x ULN within 6 months prior to randomization (excluding index event)
  • History of persistent and unexplained creatine phosphokinase (CPK) levels > 5 times the ULN as assessed within 6 months prior to randomization (excluding index event)
  • Last known eGFR < 30 mL/min/1.73m2 as assessed within 6 months prior to randomization
  • History of malignancy or any other significant comorbidity, the prognosis or management of which is likely to interfere with study conduct or subjects with a life expectancy of less than 3 years.
  • Presence of any last known laboratory value as evaluated prior to randomization that is considered by the investigator to potentially limit the patient's successful participation in the study
  • Subjects who have received any investigational drug within 1 month of randomization, or who expect to participate in any other investigational drug or device study during the conduct of this trial
  • Subjects who have undergone coronary artery bypass graft (CABG) surgery between the index event and randomization
Sources for eligibility
clinicaltrials.gov

  • Research SiteAlexander City, United StatesWithdrawn
  • Research SiteBirmingham, United StatesRecruiting
  • Research SiteFairhope, United StatesRecruiting
  • Research SiteHuntsville, United StatesRecruiting
  • Research SiteMobile, United StatesRecruiting
  • Research SiteScottsdale, United StatesRecruiting
  • Research SiteTucson, United StatesRecruiting
  • Research SiteJonesboro, United StatesWithdrawn
  • Research SiteNorth Little Rock, United StatesRecruiting
  • Research SiteGarden Grove, United StatesWithdrawn
  • Research SiteHuntington Beach, United StatesRecruiting
  • Research SiteLa Jolla, United StatesRecruiting
  • Research SiteLong Beach, United StatesWithdrawn
  • Research SiteLos Angeles, United StatesWithdrawn
  • Research SiteNewport Beach, United StatesNot yet recruiting
  • Research SiteNewport Beach, United StatesNot yet recruiting
  • Research SiteSan Francisco, United StatesRecruiting
  • Research SiteSanta Barbara, United StatesRecruiting
  • Research SiteStanford, United StatesRecruiting
  • Research SiteTorrance, United StatesRecruiting
  • Research SiteWest Hills, United StatesRecruiting
  • Research SiteAurora, United StatesRecruiting
  • Research SiteGolden, United StatesRecruiting
  • Research SiteHartford, United StatesRecruiting
  • Research SiteNew Haven, United StatesRecruiting

And 206 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Collaborators (1)

Lead sponsors (1)

Conditions (1)

Targets (1)