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

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ClinicalTrials.gov Identifier: NCT02525939
Recruitment Status : Completed
First Posted : August 18, 2015
Results First Posted : October 12, 2022
Last Update Posted : October 12, 2022
Sponsor:
Collaborators:
The Montreal Health Innovations Coordinating Center (MHICC)
Medpace, Inc.
Roche Molecular Systems, Inc
Information provided by (Responsible Party):
DalCor Pharmaceuticals

Brief Summary:
A placebo-controlled, randomized, double-blind, parallel group, phase III 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. Subject enrollment may begin in the hospital and will continue following release from the 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 (4-12 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 to reach statistical power given all other assumptions. Subjects will visit the clinic 1 month after randomization and at regular intervals thereafter. Additionally, for any subject prematurely discontinuing study medication, assessments will be conducted every 6 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. The test is investigational and test procedures are Roche Molecular Diagnostics protocol ADCY9-COB-389.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 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): The Dal-GenE Trial
Actual Study Start Date : April 2016
Actual Primary Completion Date : October 2021
Actual Study Completion Date : October 2021


Arm Intervention/treatment
Active Comparator: Dalcetrapib

Participants received dalcetrapib 600 mg (two 300 mg tablets) orally once daily.

dalcetrapib: Cholesterol Ester Transfer Protein inhibitor, 300 mg tablets

Drug: dalcetrapib
Cholesterol Ester Transfer Protein inhibitor

Placebo Comparator: Placebo

Participants received dalcetrapib placebo tablets matching dalcetrapib orally once daily.

Placebo: dalcetrapib matching placebo tablets

Drug: Placebo
matching placebo tablets




Primary Outcome Measures :
  1. Composite of Cardiovascular Death, Resuscitated Cardiac Arrest, Non-Fatal Myocardial Infarction, and Non-Fatal Stroke [ Time Frame: From randomization to the first occurrence of any component of the composite primary endpoint (median duration of follow-up was 39.9 months) ]
    All efficacy endpoints were adjudicated by an independent clinical endpoint committee (CEC). The primary efficacy endpoint was the time from randomization to the first occurrence of any component of the composite endpoint, which included death from cardiovascular causes, resuscitated cardiac arrest, non-fatal myocardial infarction, or non-fatal stroke, as positively adjudicated by the CEC.


Secondary Outcome Measures :
  1. Composite Endpoint of Cardiovascular Death, Resuscitated Cardiac Arrest, Non-Fatal Myocardial Infarction, Non-Fatal Stroke, Hospitalization for ACS (With Electrocardiogram Abnormalities) or Unanticipated Coronary Revascularization [ Time Frame: From randomization to the first occurrence of any component of the composite secondary endpoint (median duration of follow-up was 39.9 months) ]
    All efficacy endpoints were adjudicated by an independent clinical endpoint committee (CEC). The primary efficacy endpoint was the time from randomization to the first occurrence of any component of the composite endpoint, which included death from cardiovascular causes, resuscitated cardiac arrest, non-fatal myocardial infarction, non-fatal stroke, hospitalization for acute coronary syndrome (with electrocardiogram abnormalities) or unanticipated coronary revascularization, as positively adjudicated by the CEC.

  2. Composite Endpoint of Cardiovascular Death, Resuscitated Cardiac Arrest, Non-Fatal Myocardial Infarction, Non-Fatal Stroke or Hospitalization for New or Worsening Heart Failure [ Time Frame: From randomization to the first occurrence of any component of the composite secondary endpoint (median duration of follow-up was 39.9 months) ]
    All efficacy endpoints were adjudicated by an independent clinical endpoint committee (CEC). The secondary efficacy endpoint was the time from randomization to the first occurrence of any component of the composite secondary endpoint, which included death from cardiovascular causes, cardiovascular death, resuscitated cardiac arrest, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for new or worsening heart failure, as positively adjudicated by the CEC.



Information from the National Library of Medicine

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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 (between 4 and 12 weeks following the index event), will be enrolled in this trial.
  • AA genotype at variant gene as determined by Genotype Assay testing, 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, subject must have evidence of guidelines-based management of LDL-C, at a minimum to include medical and dietary treatment to a target level of LDL-C <100 mg/dl (<2.6 mmol/L).

Exclusion Criteria:

  • Females who are pregnant (negative 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 method of contraception*
  • New York Heart Association (NYHA) Class III or IV heart failure
  • Last known hemoglobin <10 g/dL
  • Index ACS event presumed due to uncontrolled hypertension

(*) Varies by region


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): NCT02525939


Locations
Show Show 563 study locations
Sponsors and Collaborators
DalCor Pharmaceuticals
The Montreal Health Innovations Coordinating Center (MHICC)
Medpace, Inc.
Roche Molecular Systems, Inc
Investigators
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Study Director: Donald M Black, MD DalCor Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by DalCor Pharmaceuticals:
Study Protocol  [PDF] February 11, 2021
Statistical Analysis Plan  [PDF] July 7, 2021

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: DalCor Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02525939    
Other Study ID Numbers: DAL-301
First Posted: August 18, 2015    Key Record Dates
Results First Posted: October 12, 2022
Last Update Posted: October 12, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: 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