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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 : Active, not recruiting
First Posted : August 18, 2015
Last Update Posted : December 19, 2018
Sponsor:
Collaborators:
The Montreal Health Innovations Coordinating Center (MHICC)
Medpace, Inc.
Roche Molecular Systems, Inc
Information provided by (Responsible Party):
DalCor Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE August 13, 2015
First Posted Date  ICMJE August 18, 2015
Last Update Posted Date December 19, 2018
Study Start Date  ICMJE April 2016
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2015)
Composite of Major Cardiovascular Adverse Events (MACE), death, MI and stroke [ Time Frame: Average of 30 months from randomization ]
time to major cardiovascular events
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02525939 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Dalcetrapib vs Placebo on CV Risk in a Genetically Defined Population With a Recent ACS
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Coronary Syndrome
Intervention  ICMJE
  • Drug: dalcetrapib
    Cholesterol Ester Transfer Protein inhibitor
  • Drug: Placebo
    matching placebo tablets
Study Arms  ICMJE
  • Active Comparator: dalcetrapib
    dalcetrapib 600 mg po QD
    Intervention: Drug: dalcetrapib
  • Placebo Comparator: placebo
    matching placebo tablet po QD
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 9, 2018)
6000
Original Estimated Enrollment  ICMJE
 (submitted: August 14, 2015)
5000
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   Czechia,   Denmark,   Finland,   France,   Germany,   Hungary,   Israel,   Italy,   Netherlands,   New Zealand,   Poland,   Portugal,   Puerto Rico,   Romania,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Turkey,   United Arab Emirates,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02525939
Other Study ID Numbers  ICMJE DAL-301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party DalCor Pharmaceuticals
Study Sponsor  ICMJE DalCor Pharmaceuticals
Collaborators  ICMJE
  • The Montreal Health Innovations Coordinating Center (MHICC)
  • Medpace, Inc.
  • Roche Molecular Systems, Inc
Investigators  ICMJE
Study Director: Donald M Black, MD DalCor Pharmaceuticals
PRS Account DalCor Pharmaceuticals
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP