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dal-GenE-2: Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS

Sponsor
DalCor Pharmaceuticals (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05918861
Collaborator
The Montreal Health Innovations Coordinating Center (MHICC) (Other)
2,000
Enrollment
60
Locations
2
Arms
50
Anticipated Duration (Months)
33.3
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

This is an event-driven study and will last until approximately 200 subjects have experienced a primary event, unless the study is stopped at the planned interim analysis. Visits after randomization will be performed as virtual visits where permissible every 3 months or as clinic visits until the study is stopped. For any subject prematurely discontinuing study medication, assessments will be conducted every 3 months for the collection of study endpoints.

Those who are likely to qualify will undergo Genotype Assay Testing to evaluate genetic determination or the presence of the AA genotype at variant rs 1967309 in the ADCY9 gene as determined by the investigational use only version of the cobas ADCY9 Genotype Test, conducted at a designated investigational testing site.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Placebo-controlled, randomized, double-blind, parallel group, multi-centerPlacebo-controlled, randomized, double-blind, parallel group, multi-center
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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.
Primary Purpose:
Treatment
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)
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2027
Anticipated Study Completion Date :
Aug 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dalcetrapib

Dalcetrapib 600 mg (two 300 mg tablets) orally once daily

Drug: Dalcetrapib
Cholesterol Ester Transfer Protein Inhibitor, 300 mg tablets
Other Names:
  • Cholesterol Ester Transfer Protein Inhibitor

    		•
    Placebo Comparator: Placebo

    Matching dalcetrapib placebo tablets (2 tablets) orally once per day

    Drug: Placebo
    matching placebo tablets
    Other Names:
  • Dalcetrapib matching placebo tablets

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time to first occurrence of any fatal or non-fatal MI [Average of 30 months from randomization]

      Time to major cardiovascular events

    Secondary Outcome Measures

    1. The composite of all-cause death, resuscitated cardiac arrest, non-fatal MI and non-fatal stroke [Average of 30 months from randomization]

      From randomization to first occurrence

    2. Composite of all-cause death, resuscitated cardiac arrest, non-fatal MI and non-fatal stroke [Average of 30 months from randomization]

      Time to first and recurrent occurrences

    3. Fatal and non-fatal MI [Average of 30 months from randomization]

      Time to first and recurrent occurrences

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Alexander City Alabama United States 35010
    2 Research Site Huntsville Alabama United States 35801
    3 Research Site Mobile Alabama United States 36602
    4 Research Site Torrance California United States 90502
    5 Research Site Littleton Colorado United States 80122
    6 Research Site Clearwater Florida United States 33755
    7 Research Site Fort Lauderdale Florida United States 33302
    8 Research Site Largo Florida United States 33770
    9 Research Site Pembroke Pines Florida United States 33023
    10 Research Site Pensacola Florida United States 32502
    11 Research Site Safety Harbor Florida United States 34695
    12 Research Site Tallahassee Florida United States 32301
    13 Research Site Newburgh Indiana United States 47629
    14 Research Site West Des Moines Iowa United States 50263
    15 Research Site Bangor Maine United States 04401
    16 Research Site Bethesda Maryland United States 20814
    17 Research Site Midland Michigan United States 48640
    18 Research Site Ypsilanti Michigan United States 48197
    19 Research Site Coon Rapids Minnesota United States 55433
    20 Research Site Duluth Minnesota United States 55802
    21 Research Site Saint Cloud Minnesota United States 56303
    22 Research Site Bridgewater New Jersey United States 08807
    23 Research Site Linden New Jersey United States 07036
    24 Research Site Pinehurst North Carolina United States 28374
    25 Research Site Winston-Salem North Carolina United States 27006
    26 Research Site Canton Ohio United States 44702
    27 Research Site Cincinnati Ohio United States 45201
    28 Research Site Springfield Ohio United States 45502
    29 Research Site Zanesville Ohio United States 43702
    30 Research Site Hershey Pennsylvania United States 17033
    31 Research Site Wyomissing Pennsylvania United States 19610
    32 Research Site Spartanburg South Carolina United States 29301
    33 Research Site Rapid City South Dakota United States 57701
    34 Research Site Greeneville Tennessee United States 37743
    35 Research Site Jackson Tennessee United States 38301
    36 Research Site Oak Ridge Tennessee United States 37830
    37 Research Site Houston Texas United States 77003
    38 Research Site Kingwood Texas United States 77339
    39 Research Site Victoria Texas United States 77901
    40 Research Site Norfolk Virginia United States 23502
    41 Research Site La Crosse Wisconsin United States 54601
    42 Research Site Calgary Alberta Canada
    43 Research Site Vancouver British Columbia Canada
    44 Research Site Victoria British Columbia Canada
    45 Research Site Winnipeg Manitoba Canada
    46 Research Site Moncton New Brunswick Canada
    47 Research Site Saint John's New Foundland Canada Newfoundland
    48 Research Site Cambridge Ontario Canada
    49 Research Site London Ontario Canada
    50 Research Site Newmarket Ontario Canada
    51 Research Site Scarborough Ontario Canada
    52 Research Site Chicoutimi Quebec Canada
    53 Research Site Laval Quebec Canada
    54 Research Site Lévis Quebec Canada
    55 Research Site Montréal Quebec Canada
    56 Research Site Québec City Quebec Canada
    57 Research Site Saint Charles Borromee Quebec Canada
    58 Research Site Saint-Jérôme Quebec Canada
    59 Research Site Terrebonne Quebec Canada
    60 Research Site Trois-Rivières Quebec Canada

    Sponsors and Collaborators

    • DalCor Pharmaceuticals
    • The Montreal Health Innovations Coordinating Center (MHICC)

    Investigators

    • Study Director: David Kallend, MBBS, DalCor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    DalCor Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT05918861
    Other Study ID Numbers:
    • DAL-302
    First Posted:
    Jun 26, 2023
    Last Update Posted:
    Jun 26, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Acute Coronary Syndrome
    Syndrome
    Dalcetrapib

    Study Results

    No Results Posted as of Jun 26, 2023