Acute Coronary SyndromePhase 3dal-GenENCT02525939

Effect of Dalcetrapib vs Placebo on CV Risk in a Genetically Defined Population With a Recent ACS

A Phase 3 study testing dalcetrapib in people with Acute Coronary Syndrome, run by DalCor Pharmaceuticals at 557 sites in 32 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 45 years and older
Conditions the study is for: Acute Coronary Syndrome
What is being tested?: dalcetrapib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 6,147 participants
Where: 557 sitesin 32 countries
Study dates: Apr 2016to Oct 2021
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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

Trial locations and contacts

557 sites in 32 countries.

Country

City, postcode or hospital

557 sites in 32 countries

United States122 sites

Research Site
Albuquerque, New Mexico
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Alexander City, Alabama
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Alexandria, Louisiana
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Alpena, Michigan
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Annapolis, Maryland
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Asheville, North Carolina
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Atlanta, Georgia
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Baltimore, Maryland
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Bangor, Maine
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Bay City, Michigan
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Bethesda, Maryland
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Biddeford, Maine
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Bridgewater, New Jersey
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Buffalo, New York
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Butler, Pennsylvania
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Canton, Ohio
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Chambersburg, Pennsylvania
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Charlottesville, Virginia
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Cincinnati, Ohio
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Clearwater, Florida
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Columbia, Maryland
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Columbus, Georgia
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Columbus, Ohio
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Coon Rapids, Minnesota
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Cottonwood, Arizona
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Covington, Georgia
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Covington, Louisiana
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Dallas, Texas
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Danbury, Connecticut
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Daytona Beach, Florida
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Decatur, Georgia
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Denver, Colorado
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Duluth, Minnesota
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Erie, Pennsylvania
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Evanston, Illinois
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Fort Lauderdale, Florida
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Fort Wayne, Indiana
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Gainesville, Florida
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Glendale, Arizona
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Greeneville, Tennessee
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Greensboro, North Carolina
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Hartford, Connecticut
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Hershey, Pennsylvania
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Homestead, Florida
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Houston, Texas
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Hudson, Florida
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Huntington Beach, California
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Huntsville, Alabama
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Hyannis, Massachusetts
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Jackson, Tennessee
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Jacksonville, Florida
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Jerseyville, Illinois
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Johnson City, New York
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Jonesboro, Arkansas
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Kingwood, Texas
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La Crosse, Wisconsin
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Langhorne, Pennsylvania
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Lansing, Michigan
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Largo, Florida
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Las Vegas, Nevada
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Layton, Utah
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Lewiston, Maine
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Linden, New Jersey
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Littleton, Colorado
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Macon, Georgia
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Miami, Florida
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Midland, Michigan
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Minneapolis, Minnesota
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Minot, North Dakota
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Miramar, Florida
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Missoula, Montana
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Mobile, Alabama
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Mount Clemens, Michigan
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Muskegon, Michigan
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New Windsor, New York
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New York, New York
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Newburgh, Indiana
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Norfolk, Virginia
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Oak Ridge, Tennessee
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Oklahoma City, Oklahoma
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Omaha, Nebraska
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Orlando, Florida
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Owensboro, Kentucky
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Pembroke Pines, Florida
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Pensacola, Florida
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Philadelphia, Pennsylvania
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Pinehurst, North Carolina
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Port Charlotte, Florida
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Poughkeepsie, New York
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Providence, Rhode Island
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Rapid City, South Dakota
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Rocky Mount, North Carolina
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Safety Harbor, Florida
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Saginaw, Michigan
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Saint Cloud, Minnesota
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Saint Joseph, Michigan
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Salisbury, Maryland
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San Antonio, Texas
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San Diego, California
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Seattle, Washington
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Somerset, New Jersey
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Spartanburg, South Carolina
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Springfield, Ohio
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St Louis, Missouri
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Summit, New Jersey
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Tallahassee, Florida
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Toledo, Ohio
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Torrance, California
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Victoria, Texas
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Virginia Beach, Virginia
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Washington, Missouri
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Washington D.C., District of Columbia
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West Des Moines, Iowa
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Wichita, Kansas
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Wichita Falls, Texas
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Wilmington, North Carolina
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Winchester, Virginia
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Winston-Salem, North Carolina
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Wyomissing, Pennsylvania
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York, Pennsylvania
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Ypsilanti, Michigan
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Zanesville, Ohio

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United Kingdom52 sites

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Canada36 sites

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Laval, Quebec
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About this study

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

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.

Read the 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.

Conditions: Acute Coronary Syndrome
Being tested: dalcetrapib, Placebo
Medical subject headings: Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

dalcetrapibDrug
Cholesterol Ester Transfer Protein inhibitor
PlaceboDrug
matching placebo tablets

Study groups in NCT02525939
Study group	Role	What they receive
Dalcetrapib	Active comparator	Participants received dalcetrapib 600 mg (two 300 mg tablets) orally once daily. dalcetrapib: Cholesterol Ester Transfer Protein inhibitor, 300 mg tablets Receives: Drug: dalcetrapib
Placebo	Placebo comparator	Participants received dalcetrapib placebo tablets matching dalcetrapib orally once daily. Placebo: dalcetrapib matching placebo tablets Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Composite of Cardiovascular Death, Resuscitated Cardiac Arrest, Non-Fatal Myocardial Infarction, and Non-Fatal Stroke
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.
Measured: From randomization to the first occurrence of any component of the composite primary endpoint (median duration of follow-up was 39.9 months)

Secondary outcomes (2)

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
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.
Measured: From randomization to the first occurrence of any component of the composite secondary endpoint (median duration of follow-up was 39.9 months)
Composite Endpoint of Cardiovascular Death, Resuscitated Cardiac Arrest, Non-Fatal Myocardial Infarction, Non-Fatal Stroke or Hospitalization for New or Worsening Heart Failure
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.
Measured: From randomization to the first occurrence of any component of the composite secondary endpoint (median duration of follow-up was 39.9 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2016Oct 2021

First posted18 Aug 2015 (estimated)
Study startApr 2016
Primary completionOct 2021
Study completionOct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 6,147 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02525939
Sponsor's protocol ID: DAL-301
Acronym: dal-GenE
Status last verified: Sep 2022
First submitted: 13 Aug 2015
Last updated: 12 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Tardif JC, Pfeffer MA, Kouz S, Koenig W, Maggioni AP, McMurray JJV, Mooser V, Waters DD, Gregoire JC, L'Allier PL, Wouter Jukema J, White HD, Heinonen T, Black DM, Laghrissi-Thode F, Levesque S, Guertin MC, Dube MP; dal-GenE Investigators. Pharmacogenetics-guided dalcetrapib therapy after an acute coronary syndrome: the dal-GenE trial. Eur Heart J. 2022 Oct 14;43(39):3947-3956. doi: 10.1093/eurheartj/ehac374.
PubMed 35856777
Black DM, Miller M, Heinonen TM, Zhang G. Advancing Beyond Failed High-density Lipoprotein Clinical Trials to Pharmacogenetic Studies of ADCY9 and Cholesterol Ester Transfer Protein Inhibition. J Cardiovasc Pharmacol. 2021 Oct 1;78(4):496-500. doi: 10.1097/FJC.0000000000001093.
PubMed 34173811
Tardif JC, Dube MP, Pfeffer MA, Waters DD, Koenig W, Maggioni AP, McMurray JJV, Mooser V, White HD, Heinonen T, Black DM, Guertin MC; dal-GenE Investigators. Study design of Dal-GenE, a pharmacogenetic trial targeting reduction of cardiovascular events with dalcetrapib. Am Heart J. 2020 Apr;222:157-165. doi: 10.1016/j.ahj.2020.01.007. Epub 2020 Jan 17.
PubMed 32087417

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Acute Coronary Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02525939
Acronym / sponsor ID: dal-GenE / DAL-301
Conditions: Acute Coronary Syndrome
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 6,147 participants (actual)
Lead sponsor: DalCor PharmaceuticalsIndustry (pharma, biotech, devices)
Collaborators: The Montreal Health Innovations Coordinating Center (MHICC), Medpace, Inc., Roche Molecular Systems, Inc
Study start: Apr 2016 (actual)
Primary completion: Oct 2021 (actual)
Study completion: Oct 2021 (actual)
First posted: 18 Aug 2015 (estimated)
Results: Posted 12 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Dalcetrapib	Active comparator	Drug: dalcetrapibParticipants received dalcetrapib 600 mg (two 300 mg tablets) orally once daily. dalcetrapib: Cholesterol Ester Transfer Protein inhibitor, 300 mg tablets
Placebo	Placebo comparator	Drug: PlaceboParticipants received dalcetrapib placebo tablets matching dalcetrapib orally once daily. Placebo: dalcetrapib matching placebo tablets

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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).

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
dalcetrapibCholesterol Ester Transfer Protein inhibitor	Drug	Dalcetrapib
Placebomatching placebo tablets	Drug	Placebo

Primary outcome

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.

2 secondary outcomes

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)
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)

Results and safety

Results posted to the registry on 12 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dalcetrapib	3,071	2,840
Placebo	3,076	2,833

Primary outcome: 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). Count of participants. Unit: Participants

Measure	Placebo n = 3076	Dalcetrapib n = 3071
Value	327	292

Placebo vs Dalcetrapib: Hazard Ratio (HR): 0.88 (95% CI 0.75 to 1.03), p = 0.12, Stratified Cox proportional hazard model

Population analysed: All subjects randomized to treatment

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	923 of 3,076 (30%)	818 of 3,076 (26.6%)	180 of 3,076
Dalcetrapib	900 of 3,071 (29.3%)	971 of 3,071 (31.6%)	182 of 3,071

Limitations and caveats (from the sponsor): The main limitation of this study is the occurrence of the COVID-19 pandemic during study conduct.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35856777Tardif JC, Pfeffer MA, Kouz S, Koenig W, Maggioni AP, McMurray JJV, Mooser V, Waters DD, Gregoire JC, L'Allier PL, Wouter Jukema J, White HD, Heinonen T, Black DM, Laghrissi-Thode F, Levesque S, Guertin MC, Dube MP; dal-GenE Investigators. Pharmacogenetics-guided dalcetrapib therapy after an acute coronary syndrome: the dal-GenE trial. Eur Heart J. 2022 Oct 14;43(39):3947-3956. doi: 10.1093/eurheartj/ehac374.
Derived from this study: PubMed 34173811Black DM, Miller M, Heinonen TM, Zhang G. Advancing Beyond Failed High-density Lipoprotein Clinical Trials to Pharmacogenetic Studies of ADCY9 and Cholesterol Ester Transfer Protein Inhibition. J Cardiovasc Pharmacol. 2021 Oct 1;78(4):496-500. doi: 10.1097/FJC.0000000000001093.
Derived from this study: PubMed 32087417Tardif JC, Dube MP, Pfeffer MA, Waters DD, Koenig W, Maggioni AP, McMurray JJV, Mooser V, White HD, Heinonen T, Black DM, Guertin MC; dal-GenE Investigators. Study design of Dal-GenE, a pharmacogenetic trial targeting reduction of cardiovascular events with dalcetrapib. Am Heart J. 2020 Apr;222:157-165. doi: 10.1016/j.ahj.2020.01.007. Epub 2020 Jan 17.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Donald M Black, MD study director

DalCor Pharmaceuticals

557 sites in 32 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing dalcetrapib in people with Acute Coronary Syndrome, run by DalCor Pharmaceuticals at 557 sites in 32 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 557 sites in United States, United Kingdom, Canada, Argentina, Netherlands and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02525939, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.