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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 : Recruiting
First Posted : August 18, 2015
Last Update Posted : September 26, 2018
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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6000 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
Study Start Date : April 2016
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: dalcetrapib
dalcetrapib 600 mg po QD
Drug: dalcetrapib
Cholesterol Ester Transfer Protein inhibitor

Placebo Comparator: placebo
matching placebo tablet po QD
Drug: Placebo
matching placebo tablets




Primary Outcome Measures :
  1. Composite of Major Cardiovascular Adverse Events (MACE), death, MI and stroke [ Time Frame: Average of 30 months from randomization ]
    time to major cardiovascular events



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


Contacts
Contact: Donald M Black, MD 609-613-6637 dblack@dalcorpharma.com
Contact: Heinonen dalcorpharma@gmail.com

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Sponsors and Collaborators
DalCor Pharmaceuticals
The Montreal Health Innovations Coordinating Center (MHICC)
Medpace, Inc.
Roche Molecular Systems, Inc
Investigators
Study Director: Donald M Black, MD DalCor Pharmaceuticals

Responsible Party: DalCor Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02525939     History of Changes
Other Study ID Numbers: DAL-301
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Syndrome
Acute Coronary 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