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

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ClinicalTrials.gov Identifier: NCT05918861
Recruitment Status : Recruiting
First Posted : June 26, 2023
Last Update Posted : April 15, 2024
Sponsor:
Collaborator:
The Montreal Health Innovations Coordinating Center (MHICC)
Information provided by (Responsible Party):
DalCor Pharmaceuticals

Study Description
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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
Acute Coronary Syndrome Drug: Dalcetrapib Drug: Placebo 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Placebo-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)
Actual Study Start Date : October 3, 2023
Estimated Primary Completion Date : August 2027
Estimated Study Completion Date : August 2027

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Arms and Interventions
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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 Name: Cholesterol Ester Transfer Protein Inhibitor
Placebo Comparator: Placebo
Matching dalcetrapib placebo tablets (2 tablets) orally once per day
 Drug: Placebo
matching placebo tablets
Other Name: Dalcetrapib matching placebo tablets


Outcome Measures
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Primary Outcome Measures :
  1. Time to first occurrence of any fatal or non-fatal myocardial infarction (MI) [ Time Frame: Average of 30 months from randomization ]
    Time to patients experiencing major cardiovascular events


Secondary Outcome Measures :
  1. The composite of all-cause death, resuscitated cardiac arrest, non-fatal MI and non-fatal stroke [ Time Frame: 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 [ Time Frame: Average of 30 months from randomization ]
    Time to patients experiencing first and recurrent occurrences

  3. Fatal and non-fatal MI [ Time Frame: Average of 30 months from randomization ]
    Time to patients experiencing first and recurrent occurrences


Eligibility Criteria
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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05918861


Contacts
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Contact: David Kallend, MBBS +41 79 174 1830 dkallend@dalcorpharma.com
Contact: Therese Heinonen, DVM theinonen@dalcorpharma.com

Locations
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Sponsors and Collaborators
DalCor Pharmaceuticals
The Montreal Health Innovations Coordinating Center (MHICC)
Investigators
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Study Director: David Kallend, MBBS DalCor
More Information
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Responsible Party: DalCor Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05918861    
Other Study ID Numbers: DAL-302
First Posted: June 26, 2023    Key Record Dates
Last Update Posted: April 15, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
 Vascular Diseases
Dalcetrapib
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents