Effect of Dalcetrapib vs Placebo on CV Risk in a Genetically Defined Population With a Recent ACS
NCT ID: NCT02525939
Last Updated: 2022-10-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
6147 participants
INTERVENTIONAL
2016-04-30
2021-10-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dalcetrapib
Participants received dalcetrapib 600 mg (two 300 mg tablets) orally once daily.
dalcetrapib: Cholesterol Ester Transfer Protein inhibitor, 300 mg tablets
dalcetrapib
Cholesterol Ester Transfer Protein inhibitor
Placebo
Participants received dalcetrapib placebo tablets matching dalcetrapib orally once daily.
Placebo: dalcetrapib matching placebo tablets
Placebo
matching placebo tablets
Interventions
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dalcetrapib
Cholesterol Ester Transfer Protein inhibitor
Placebo
matching placebo tablets
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
45 Years
ALL
No
Sponsors
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The Montreal Health Innovations Coordinating Center (MHICC)
OTHER
Medpace, Inc.
INDUSTRY
Roche Molecular Systems, Inc
INDUSTRY
DalCor Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Donald M Black, MD
Role: STUDY_DIRECTOR
DalCor Pharmaceuticals
Locations
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Alexander City, Alabama, United States
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Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Cottonwood, Arizona, United States
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Glendale, Arizona, United States
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Jonesboro, Arkansas, United States
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Huntington Beach, California, United States
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San Diego, California, United States
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Torrance, California, United States
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Denver, Colorado, United States
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Littleton, Colorado, United States
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Danbury, Connecticut, United States
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Hartford, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Clearwater, Florida, United States
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Daytona Beach, Florida, United States
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Fort Lauderdale, Florida, United States
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Gainesville, Florida, United States
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Homestead, Florida, United States
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Hudson, Florida, United States
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Jacksonville, Florida, United States
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Largo, Florida, United States
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Miami, Florida, United States
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Miramar, Florida, United States
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Orlando, Florida, United States
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Pembroke Pines, Florida, United States
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Pensacola, Florida, United States
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Port Charlotte, Florida, United States
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Safety Harbor, Florida, United States
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Tallahassee, Florida, United States
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Atlanta, Georgia, United States
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Columbus, Georgia, United States
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Covington, Georgia, United States
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Decatur, Georgia, United States
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Macon, Georgia, United States
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Evanston, Illinois, United States
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Jerseyville, Illinois, United States
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Fort Wayne, Indiana, United States
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Newburgh, Indiana, United States
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West Des Moines, Iowa, United States
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Wichita, Kansas, United States
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Owensboro, Kentucky, United States
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Alexandria, Louisiana, United States
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Covington, Louisiana, United States
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Bangor, Maine, United States
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Biddeford, Maine, United States
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Lewiston, Maine, United States
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Annapolis, Maryland, United States
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Bethesda, Maryland, United States
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Columbia, Maryland, United States
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Salisbury, Maryland, United States
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Hyannis, Massachusetts, United States
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Alpena, Michigan, United States
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Bay City, Michigan, United States
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Lansing, Michigan, United States
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Muskegon, Michigan, United States
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Saginaw, Michigan, United States
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Saint Joseph, Michigan, United States
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Ypsilanti, Michigan, United States
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Asheville, North Carolina, United States
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Minot, North Dakota, United States
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Springfield, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Butler, Pennsylvania, United States
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Romford, , United Kingdom
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Rotherham, , United Kingdom
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Salford, , United Kingdom
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Sheffield, , United Kingdom
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Stevenage, , United Kingdom
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Stockport, , United Kingdom
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Stockton-on-Tees, , United Kingdom
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Swindon, , United Kingdom
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Taunton, , United Kingdom
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Telford, , United Kingdom
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Truro, , United Kingdom
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West Bromwich, , United Kingdom
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Westcliff-on-Sea, , United Kingdom
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Wigan, , United Kingdom
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Worcester, , United Kingdom
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Worthing, , United Kingdom
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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DAL-301
Identifier Type: -
Identifier Source: org_study_id
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