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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02525939




Registration number
NCT02525939
Ethics application status
Date submitted
13/08/2015
Date registered
18/08/2015
Date last updated
12/10/2022

Titles & IDs
Public title
Effect of Dalcetrapib vs Placebo on CV Risk in a Genetically Defined Population With a Recent ACS
Scientific 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
Secondary ID [1] 0 0
DAL-301
Universal Trial Number (UTN)
Trial acronym
dal-GenE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - dalcetrapib
Treatment: Drugs - Placebo

Active Comparator: Dalcetrapib - Participants received dalcetrapib 600 mg (two 300 mg tablets) orally once daily.
dalcetrapib: Cholesterol Ester Transfer Protein inhibitor, 300 mg tablets

Placebo Comparator: Placebo - Participants received dalcetrapib placebo tablets matching dalcetrapib orally once daily.
Placebo: dalcetrapib matching placebo tablets


Treatment: Drugs: dalcetrapib
Cholesterol Ester Transfer Protein inhibitor

Treatment: Drugs: Placebo
matching placebo tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of Cardiovascular Death, Resuscitated Cardiac Arrest, Non-Fatal Myocardial Infarction, and Non-Fatal Stroke
Timepoint [1] 0 0
From randomization to the first occurrence of any component of the composite primary endpoint (median duration of follow-up was 39.9 months)
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
From randomization to the first occurrence of any component of the composite secondary endpoint (median duration of follow-up was 39.9 months)
Secondary outcome [2] 0 0
Composite Endpoint of Cardiovascular Death, Resuscitated Cardiac Arrest, Non-Fatal Myocardial Infarction, Non-Fatal Stroke or Hospitalization for New or Worsening Heart Failure
Timepoint [2] 0 0
From randomization to the first occurrence of any component of the composite secondary endpoint (median duration of follow-up was 39.9 months)

Eligibility
Key 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).
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2021
Sample size
Target
Accrual to date
Final
6147
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
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Research Site - Bruce
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- Gosford
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- Milton
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- Redcliffe
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- Bedford Park
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- Elizabeth Vale
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- Woodville South
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- Hobart
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- Epping
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- Geelong
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- Melbourne
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- Joondalup
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- Murdoch
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- Nedlands
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- Perth
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Worthing

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
DalCor Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Montreal Health Innovations Coordinating Center (MHICC)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Medpace, Inc.
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/Industry
Name [3] 0 0
Roche Molecular Systems, Inc
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02525939
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Donald M Black, MD
Address 0 0
DalCor Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries