Clinical trial NCT02525939: Effect of Dalcetrapib vs Placebo on CV Risk in a Genetically Defined Population With a Recent ACS
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Coronary Syndrome
Lead sponsor: DalCor Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: The Montreal Health Innovations Coordinating Center (MHICC)
name: Medpace, Inc.
name: Roche Molecular Systems, Inc
First posted: 2015-08-18
Enrollment: 6147
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Composite of Cardiovascular Death, Resuscitated Cardiac Arrest, Non-Fatal Myocardial Infarction, and Non-Fatal Stroke
timeFrame: 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:
measure: 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
timeFrame: From randomization to the first occurrence of any component of the composite secondary endpoint (median duration of follow-up was 39.9 months)
measure: Composite Endpoint of Cardiovascular Death, Resuscitated Cardiac Arrest, Non-Fatal Myocardial Infarction, Non-Fatal Stroke or Hospitalization for New or Worsening Heart Failure
timeFrame: From randomization to the first occurrence of any component of the composite secondary endpoint (median duration of follow-up was 39.9 months)
Other outcomes:
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city: Zalaegerszeg
country: Hungary
facility: Research Site
city: Afula
country: Israel
facility: Research Site
city: Ashkelon
country: Israel
facility: Research Site
city: Beer Sheva
country: Israel
facility: Research Site
city: Bnei Brak
country: Israel
facility: Research Site
city: Haifa
country: Israel
facility: Research Site
city: Holon
country: Israel
facility: Research Site
city: Jerusalem
country: Israel
facility: Research Site
city: Kfar Saba
country: Israel
facility: Research Site
city: Nahariya
country: Israel
facility: Research Site
city: Nazareth
country: Israel
facility: Research Site
city: Petach-Tikva
country: Israel
facility: Research Site
city: Poriyya 'Illit
country: Israel
facility: Research Site
city: Rehovot
country: Israel
facility: Research Site
city: Safed
country: Israel
facility: Research Site
city: Tel Aviv
country: Israel
facility: Research Site
city: Tel Hashomer
country: Israel
facility: Research Site
city: Zerifin
country: Israel
facility: Research Site
city: Ancona
country: Italy
facility: Research Site
city: Ascoli Piceno
country: Italy
facility: Research Site
city: Cagliari
country: Italy
facility: Research Site
city: Casarano
country: Italy
facility: Research Site
city: Cortona
country: Italy
facility: Research Site
city: Empoli
country: Italy
facility: Research Site
city: Firenze
country: Italy
facility: Research Site
city: Foggia
country: Italy
facility: Research Site
city: Giugliano in Campania
country: Italy
facility: Research Site
city: Gubbio
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Novara
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Rozzano
country: Italy
facility: Research Site
city: Sanremo
country: Italy
facility: Research Site
city: Saronno
country: Italy
facility: Research Site
city: Scorrano
country: Italy
facility: Research Site
city: Seriate
country: Italy
facility: Research Site
city: Torino
country: Italy
facility: Research Site
city: Treviglio
country: Italy
facility: Research Site
city: 's-Hertogenbosch
country: Netherlands
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Arnhem
country: Netherlands
facility: Research Site
city: Capelle Aan Den IJssel
country: Netherlands
facility: Research Site
city: Den Haag
country: Netherlands
facility: Research Site
city: Deventer
country: Netherlands
facility: Research Site
city: Doetinchem
country: Netherlands
facility: Research Site
city: Ede
country: Netherlands
facility: Research Site
city: Goes
country: Netherlands
facility: Research Site
city: Gouda
country: Netherlands
facility: Research Site
city: Hoogeveen
country: Netherlands
facility: Research Site
city: Hoorn
country: Netherlands
facility: Research Site
city: Leeuwarden
country: Netherlands
facility: Research Site
city: Leiden
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Schiedam
country: Netherlands
facility: Research Site
city: Sneek
country: Netherlands
facility: Research Site
city: Tiel
country: Netherlands
facility: Research Site
city: Tilburg
country: Netherlands
facility: Research Site
city: Uden
country: Netherlands
facility: Research Site
city: Veldhoven
country: Netherlands
facility: Research Site
city: Venlo
country: Netherlands
facility: Research Site
city: Zaandam
country: Netherlands
facility: Research Site
city: Zutphen
country: Netherlands
facility: Research Site
city: Christchurch
country: New Zealand
facility: Research Site
city: Dunedin
country: New Zealand
facility: Research Site
city: Grafton
country: New Zealand
facility: Research Site
city: Hamilton
country: New Zealand
facility: Research Site
city: Hastings
country: New Zealand
facility: Research Site
city: Lower Hutt
country: New Zealand
facility: Research Site
city: Nelson
country: New Zealand
facility: Research Site
city: New Plymouth
country: New Zealand
facility: Research Site
city: Rotorua
country: New Zealand
facility: Research Site
city: Takapuna
country: New Zealand
facility: Research Site
city: Wellington
country: New Zealand
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Elblag
country: Poland
facility: Research Site
city: Gdynia
country: Poland
facility: Research Site
city: Kielce
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Mragowo
country: Poland
facility: Research Site
city: Olawa
country: Poland
facility: Research Site
city: Oswiecim
country: Poland
facility: Research Site
city: Plock
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Ruda Slaska
country: Poland
facility: Research Site
city: Rzeszow
country: Poland
facility: Research Site
city: Sopot
country: Poland
facility: Research Site
city: Sroda Wielkopolska
country: Poland
facility: Research Site
city: Szczecin
country: Poland
facility: Research Site
city: Torun
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Zabrze
country: Poland
facility: Research Site
city: Zamosc
country: Poland
facility: Research Site
city: Almada
country: Portugal
facility: Research Site
city: Braga
country: Portugal
facility: Research Site
city: Coimbra
country: Portugal
facility: Research Site
city: Faro
country: Portugal
facility: Research Site
city: Leiria
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Senhora da Hora
country: Portugal
facility: Research Site
city: Setubal
country: Portugal
facility: Research Site
city: Bayamon
country: Puerto Rico
facility: Research Site
city: Caguas
country: Puerto Rico
facility: Research Site
city: Ponce
country: Puerto Rico
facility: Research Site
city: Arad
country: Romania
facility: Research Site
city: Baia Mare
country: Romania
facility: Research Site
city: Braila
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Buzau
country: Romania
facility: Research Site
city: Cluj-Napoca
country: Romania
facility: Research Site
city: Craiova
country: Romania
facility: Research Site
city: Oradea
country: Romania
facility: Research Site
city: Pitesti
country: Romania
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
city: Arkhangelsk
country: Russian Federation
facility: Research Site
city: Barnaul
country: Russian Federation
facility: Research Site
city: Ekaterinburg
country: Russian Federation
facility: Research Site
city: Irkutsk
country: Russian Federation
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Kemerovo
country: Russian Federation
facility: Research Site
city: Kirovsk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Nizhny Novgorod
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Omsk
country: Russian Federation
facility: Research Site
city: Orenburg
country: Russian Federation
facility: Research Site
city: Penza
country: Russian Federation
facility: Research Site
city: Petrozavodsk
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Saratov
country: Russian Federation
facility: Research Site
city: Tomsk
country: Russian Federation
facility: Research Site
city: Tula
country: Russian Federation
facility: Research Site
city: Tyumen
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
city: Bardejov
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Lucenec
country: Slovakia
facility: Research Site
city: Namestovo
country: Slovakia
facility: Research Site
city: Nitra
country: Slovakia
facility: Research Site
city: Bloemfontein
country: South Africa
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Gatong
country: South Africa
facility: Research Site
city: Johannesburg
country: South Africa
facility: Research Site
city: Kuils River
country: South Africa
facility: Research Site
city: Paarl
country: South Africa
facility: Research Site
city: Parow
country: South Africa
facility: Research Site
city: Somerset West
country: South Africa
facility: Research Site
city: Worcester
country: South Africa
facility: Research Site
city: A Coruna
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Hospitalet del Llobregat
country: Spain
facility: Research Site
city: Lleida
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Sabadell
country: Spain
facility: Research Site
city: Salamanca
country: Spain
facility: Research Site
city: Sant Joan
country: Spain
facility: Research Site
city: Santiago de Compostela
country: Spain
facility: Research Site
city: Seville
country: Spain
facility: Research Site
city: Tarragona
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Vigo
country: Spain
facility: Research Site
city: Falun
country: Sweden
facility: Research Site
city: Karlshamn
country: Sweden
facility: Research Site
city: Koping
country: Sweden
facility: Research Site
city: Linkoping
country: Sweden
facility: Research Site
city: Malmo
country: Sweden
facility: Research Site
city: Orebro
country: Sweden
facility: Research Site
city: Umea
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Vasteras
country: Sweden
facility: Research Site
city: Geneva
country: Switzerland
facility: Research Site
city: Lugano
country: Switzerland
facility: Research Site
city: Afyonkarahisar
country: Turkey
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Kadikoy
country: Turkey
facility: Research Site
city: Kayseri
country: Turkey
facility: Research Site
city: Mersin
country: Turkey
facility: Research Site
city: Samsun
country: Turkey
facility: Research Site
city: Sivas
country: Turkey
facility: Research Site
city: Dubai
country: United Arab Emirates
facility: Research Site
city: Sharjah
country: United Arab Emirates
facility: Research Site
city: Ayr
country: United Kingdom
facility: Research Site
city: Barnet
country: United Kingdom
facility: Research Site
city: Basildon
country: United Kingdom
facility: Research Site
city: Belfast
country: United Kingdom
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Blackpool
country: United Kingdom
facility: Research Site
city: Bradford
country: United Kingdom
facility: Research Site
city: Bristol
country: United Kingdom
facility: Research Site
city: Burton Upon Trent
country: United Kingdom
facility: Research Site
city: Chelmsford
country: United Kingdom
facility: Research Site
city: Chertsey
country: United Kingdom
facility: Research Site
city: Clydebank
country: United Kingdom
facility: Research Site
city: Coventry
country: United Kingdom
facility: Research Site
city: Craigavon
country: United Kingdom
facility: Research Site
city: Dartford
country: United Kingdom
facility: Research Site
city: Dudley
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Harrow
country: United Kingdom
facility: Research Site
city: High Wycombe
country: United Kingdom
facility: Research Site
city: Hull
country: United Kingdom
facility: Research Site
city: Inverness
country: United Kingdom
facility: Research Site
city: Kirkcaldy
country: United Kingdom
facility: Research Site
city: Lanark
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: Lincoln
country: United Kingdom
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: Londonderry
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Luton
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Newcastle
country: United Kingdom
facility: Research Site
city: Newport
country: United Kingdom
facility: Research Site
city: Northampton
country: United Kingdom
facility: Research Site
city: Nuneaton
country: United Kingdom
facility: Research Site
city: Paisley
country: United Kingdom
facility: Research Site
city: Redhill
country: United Kingdom
facility: Research Site
city: Romford
country: United Kingdom
facility: Research Site
city: Rotherham
country: United Kingdom
facility: Research Site
city: Salford
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
city: Stevenage
country: United Kingdom
facility: Research Site
city: Stockport
country: United Kingdom
facility: Research Site
city: Stockton on Tees
country: United Kingdom
facility: Research Site
city: Swindon
country: United Kingdom
facility: Research Site
city: Taunton
country: United Kingdom
facility: Research Site
city: Telford
country: United Kingdom
facility: Research Site
city: Truro
country: United Kingdom
facility: Research Site
city: West Bromwich
country: United Kingdom
facility: Research Site
city: Westcliff on Sea
country: United Kingdom
facility: Research Site
city: Wigan
country: United Kingdom
facility: Research Site
city: Worcester
country: United Kingdom
facility: Research Site
city: Worthing
country: United Kingdom
facility: Research Site
Study officials:
affiliation: DalCor Pharmaceuticals
name: Donald M Black, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.