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

Acute Coronary Syndrome Clinical Trial

— dal-GenE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02525939
• Other study ID #: DAL-301
• Status: Completed
• Phase: Phase 3
• Start date: April 2016
• Est. completion date: October 2021

Study information

• Verified date: September 2022
• Source: DalCor Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6147
• Est. completion date: October 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• dalcetrapib
Cholesterol Ester Transfer Protein inhibitor
• Placebo
matching placebo tablets

Locations

Country	Name	City	State
Argentina	Research Site	Bahía Blanca
Argentina	Research Site	Ciudad Autonoma de Buenos Aires
Argentina	Research Site	Cordoba
Argentina	Research Site	Coronel Suarez
Argentina	Research Site	Corrientes
Argentina	Research Site	Esperanza
Argentina	Research Site	Junin
Argentina	Research Site	La Plata
Argentina	Research Site	Mar del Plata
Argentina	Research Site	Mendoza
Argentina	Research Site	Moron
Argentina	Research Site	Quilmes
Argentina	Research Site	Rosario
Argentina	Research Site	San Juan
Argentina	Research Site	San Luis
Argentina	Research Site	San Martin
Argentina	Research Site	San Miguel de Tucuman
Argentina	Research Site	San Nicolas
Argentina	Research Site	Santa Fe
Argentina	Research Site	Santa Rosa
Argentina	Research Site	Tucuman
Argentina	Research Site	Venado Tuerto
Argentina	Research Site	Vicente Lopez
Argentina	Research Site	Villa Allende
Argentina	Research Site	Villa Maria
Australia	Research Site	Bedford Park	South Australia
Australia	Research Site	Bruce	New South Wales
Australia	Research Site	Cairns	Queensland
Australia	Research Site	Chermside	Queensland
Australia	Research Site	Douglas	Queensland
Australia	Research Site	Elizabeth Vale	South Australia
Australia	Research Site	Epping	Victoria
Australia	Research Site	Geelong	Victoria
Australia	Research Site	Gosford	New South Wales
Australia	Research Site	Herston	Queensland
Australia	Research Site	Hobart	Tasmania
Australia	Research Site	Joondalup	Western Australia
Australia	Research Site	Liverpool	New South Wales
Australia	Research Site	Melbourne	Victoria
Australia	Research Site	Milton	Queensland
Australia	Research Site	Murdoch	Western Australia
Australia	Research Site	Nedlands	Western Australia
Australia	Research Site	Perth	Western Australia
Australia	Research Site	Redcliffe	Queensland
Australia	Research Site	Saint Leonards	New South Wales
Australia	Research Site	Woodville South	South Australia
Australia	Research Site	Woolloongabba	Queensland
Austria	Research Site	Braunau Am Inn
Austria	Research Site	Feldkirch
Austria	Research Site	Krems
Austria	Research Site	Linz
Austria	Research Site	Vienna
Austria	Research Site	Wien
Austria	Research Site	Wiener Neustadt
Belgium	Research Site	Aalst
Belgium	Research Site	Bonheiden
Belgium	Research Site	Brussels
Belgium	Research Site	Genk
Belgium	Research Site	Liege
Belgium	Research Site	Maaseik
Belgium	Research Site	Mechelen
Belgium	Research Site	Ottignies
Belgium	Research Site	Sint-Niklaas
Brazil	Research Site	Belo Horizonte
Brazil	Research Site	Blumenau
Brazil	Research Site	Brasilia
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Brazil	Research Site	Campinas
Brazil	Research Site	Campo Grande
Brazil	Research Site	Curitiba
Brazil	Research Site	Fortaleza
Brazil	Research Site	Goiania
Brazil	Research Site	Marilia
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Brazil	Research Site	Salvador
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Brazil	Research Site	Uberlandia
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Canada	Research Site	Bridgewater	Nova Scotia
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Canada	Research Site	Cambridge	Ontario
Canada	Research Site	Chicoutimi	Quebec
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Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Laval	Quebec
Canada	Research Site	Levis	Quebec
Canada	Research Site	London	Ontario
Canada	Research Site	Longueuil	Quebec
Canada	Research Site	Moncton	New Brunswick
Canada	Institut de Cardiologie de Montreal	Montreal	Quebec
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Newmarket	Ontario
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Peterborough	Ontario
Canada	Research Site	Quebec
Canada	Research Site	Québec
Canada	Research Site	Saint John	New Brunswick
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Canada	Research Site	Sherbrooke	Quebec
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Portugal	Research Site	Almada
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Slovakia	Research Site	Bardejov
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Slovakia	Research Site	Kosice
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South Africa	Research Site	Bloemfontein
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South Africa	Research Site	Parow
South Africa	Research Site	Somerset West
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Spain	Research Site	A Coruna
Spain	Research Site	Barcelona
Spain	Research Site	Hospitalet del Llobregat
Spain	Research Site	Lleida
Spain	Research Site	Madrid
Spain	Research Site	Malaga
Spain	Research Site	Sabadell
Spain	Research Site	Salamanca
Spain	Research Site	Sant Joan
Spain	Research Site	Santiago de Compostela
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Spain	Research Site	Tarragona
Spain	Research Site	Valencia
Spain	Research Site	Vigo
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Switzerland	Research Site	Geneva
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Turkey	Research Site	Afyonkarahisar
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Turkey	Research Site	Istanbul
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Turkey	Research Site	Sivas
United Arab Emirates	Research Site	Dubai
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United Kingdom	Research Site	Ayr
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United States	Research Site	Safety Harbor	Florida
United States	Research Site	Saginaw	Michigan
United States	Research Site	Saint Cloud	Minnesota
United States	Research Site	Saint Joseph	Michigan
United States	Research Site	Saint Louis	Missouri
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United States	Research Site	San Antonio	Texas
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United States	Research Site	Summit	New Jersey
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United States	Research Site	Torrance	California
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United States	Research Site	Virginia Beach	Virginia
United States	Research Site	Washington	District of Columbia
United States	Research Site	Washington	Missouri
United States	Research Site	West Des Moines	Iowa
United States	Research Site	Wichita	Kansas
United States	Research Site	Wichita Falls	Texas
United States	Research Site	Wilmington	North Carolina
United States	Research Site	Winchester	Virginia
United States	Research Site	Winston-Salem	North Carolina
United States	Research Site	Wyomissing	Pennsylvania
United States	Research Site	York	Pennsylvania
United States	Research Site	Ypsilanti	Michigan
United States	Research Site	Zanesville	Ohio

Sponsors (4)

Lead Sponsor	Collaborator
DalCor Pharmaceuticals	Medpace, Inc., Roche Molecular Systems, Inc, The Montreal Health Innovations Coordinating Center (MHICC)

Countries where clinical trial is conducted

United States,  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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From randomization to the first occurrence of any component of the composite primary endpoint (median duration of follow-up was 39.9 months)
Secondary	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.	From randomization to the first occurrence of any component of the composite secondary endpoint (median duration of follow-up was 39.9 months)
Secondary	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.	From randomization to the first occurrence of any component of the composite secondary endpoint (median duration of follow-up was 39.9 months)