Tests dalcetrapib against placebo in people with a recent heart attack-related condition
Tests dalcetrapib against placebo in adults recently hospitalized for acute coronary syndrome.
Key facts
- Who runs it
- DalCor Pharmaceuticals
- Where
- Abbotsford British Columbia, Brampton, Burnaby, Calgary, Cambridge, Chicoutimi, Edmonton, Granby, Greenfield Park, Halifax, Kamloops, Kingston, Laval, Lévis, London, Moncton, Montreal, Newmarket, North Vancouver, Ottawa, Québec, Rimouski, Saint-Charles-Borromée, Saint-Hubert, Saint-Jérôme, Saskatoon, Scarborough Village, Sherbrooke, St. John's, Terrebonne, Toronto, Trois-Rivières, Vancouver, Victoria, and Winnipeg, CanadaSee the 35 sitesAlso in 2 other countries, 164 sites
- Trial code
- Registry title
- Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 2,000 people, planned
- Started
- 3 Oct 2023
- Expected to end
- Aug 2027
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Dalcetrapib
- Placebo
- Record updated
- 22 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 45 or older who were recently in hospital for acute coronary syndrome and have the AA genotype at a specific gene variant.
- Age
- 45 years and over
- Sex
- Men and women
- Disease stage
- Recently hospitalized for acute coronary syndrome (ACS), up to 3 months after the event. Clinically stable: no ischemic symptoms at rest or with minimal exertion for at least 1 week before randomization.
- Earlier treatment
- Before randomization, there must be evidence of guidelines-based management of LDL-C, at a minimum medical and dietary treatment. Cannot have had any investigational drug within 1 month before randomization.
- Biomarker or test result
- AA genotype at the variant gene, confirmed by the Genotype Assay Test at a designated investigational testing site.
Main reasons for not taking part
- Pregnant or breast-feeding women
- NYHA Class III or IV heart failure
- Clinically apparent liver disease, or eGFR below 30 mL/min/1.73m2 within 6 months before randomization
- Coronary artery bypass graft (CABG) surgery between the ACS event and randomization
- History of malignancy or another major illness likely to interfere with the trial, or life expectancy under 3 years
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- Subjects with the appropriate genetic background and recently hospitalized for ACS (up to 3 months following the index event), will be enrolled in this trial
- Both male and female subjects age 45 years and over at screening visit (V1)
- AA genotype at variant gene as determined by Genotype Assay Test, 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, subjects must have evidence of guidelines-based management of LDL-C, at a minimum to include medical and dietary treatment
- Randomization within 3 months of the index ACS event
Who cannot take part
- Systolic blood pressure (BP) >180 mmHg and/or diastolic blood pressure >110 mmHg at the time of randomization despite anti-hypertensive therapy
- Subjects who have received any investigational drug within 1 month of randomization, or who expect to participate in any other investigational drug or device study during the conduct of this trial
- Subjects who have undergone coronary artery bypass graft (CABG) surgery between the index event and randomization
- New York Heart Association (NYHA) Class III or IV heart failure
- Index ACS event presumed due to uncontrolled hypertension
- History of malignancy or any other significant comorbidity, the prognosis or management of which is likely to interfere with study conduct or subjects with a life expectancy of less than 3 years
- Subjects with clinically apparent liver disease, eg, jaundice, cholestasis, hepatic synthetic impairment, active hepatitis or last known ALT or AST level >3 x ULN within 6 months prior to randomization (excluding index event)
- History of persistent and unexplained creatine phosphokinase (CPK) levels > 5 times the ULN as assessed within 6 months prior to randomization (excluding index event)
- Last known eGFR < 30 mL/min/1.73m2 as assessed within 6 months prior to randomization
- Presence of any last known laboratory value as evaluated prior to randomization that is considered by the investigator to potentially limit the patient's successful participation in the study
- Females who are pregnant (negative urine 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 highly effective method of contraception
Where in Canada
Also in 2 other countries, 164 sites
- Abbotsford British Columbia, British ColumbiaHospital not named in the registryContact: David Kallend, MBBSTaking people
- Brampton, OntarioHospital not named in the registryContact: David Kallend, MBBSNot yet recruiting
- Burnaby, British ColumbiaHospital not named in the registryContact: David Kallend, MBBSTaking people
- Calgary, AlbertaHospital not named in the registryContact: David Kallend, MBBSNo longer taking part
- Cambridge, OntarioHospital not named in the registryContact: David Kallend, MBBSTaking people
- ChicoutimiHospital not named in the registryContact: David Kallend, MBBSNo longer taking part
- Edmonton, AlbertaHospital not named in the registryContact: David Kallend, MBBSTaking people
- Granby, QuebecHospital not named in the registryContact: David Kallend, MBBSTaking people
- Greenfield Park, QuebecHospital not named in the registryContact: David Kallend, MBBSTaking people
- Halifax, Nova ScotiaHospital not named in the registryContact: David Kallend, MBBSTaking people
- Kamloops, British ColumbiaHospital not named in the registryContact: David Kallend, MBBSTaking people
- Kingston, OntarioHospital not named in the registryContact: David Kallend, MBBSTaking people
- Laval, QuebecHospital not named in the registryContact: David Kallend, MBBSNo longer taking part
- Lévis, QuebecHospital not named in the registryContact: David Kallend, MBBSTaking people
- London, OntarioHospital not named in the registryContact: David Kallend, MBBSTaking people
- Moncton, New BrunswickHospital not named in the registryContact: David Kallend, MBBSTaking people
- Montreal, QuebecHospital not named in the registryContact: David Kallend, MBBSTaking people
- Newmarket, OntarioHospital not named in the registryContact: David Kallend, MBBSTaking people
- North Vancouver, British ColumbiaHospital not named in the registryContact: David Kallend, MBBSNo longer taking part
- Ottawa, OntarioHospital not named in the registryContact: David Kallend, MBBSNot yet recruiting
- Québec, QuebecHospital not named in the registryContact: David Kallend, MBBSTaking people
- Rimouski, QuebecHospital not named in the registryContact: David Kallend, MBBSTaking people
- Saint-Charles-Borromée, QuebecHospital not named in the registryContact: David Kallend, MBBSTaking people
- Saint-Hubert, QuebecHospital not named in the registryContact: David Kallend, MBBSTaking people
- Saint-Jérôme, QuebecHospital not named in the registryContact: David Kallend, MBBSTaking people
- Saskatoon, SaskatchewanHospital not named in the registryContact: David Kallend, MBBSNot yet recruiting
- Scarborough Village, OntarioHospital not named in the registryContact: David Kallend, MBBSTaking people
- Sherbrooke, QuebecHospital not named in the registryContact: David Kallend, MBBSTaking people
- St. John's, Newfoundland and LabradorHospital not named in the registryContact: David Kallend, MBBSNo longer taking part
- Terrebonne, QuebecHospital not named in the registryContact: David Kallend, MBBSTaking people
- Toronto, OntarioHospital not named in the registryContact: David Kallend, MBBSTaking people
- Trois-Rivières, QuebecHospital not named in the registryContact: David Kallend, MBBSTaking people
- Vancouver, British ColumbiaHospital not named in the registryContact: David Kallend, MBBSNot yet recruiting
- Victoria, British ColumbiaHospital not named in the registryContact: David Kallend, MBBSNo longer taking part
- Winnipeg, ManitobaHospital not named in the registryContact: David Kallend, MBBSTaking people
About the trial
What the trial wants to find out
This is a placebo-controlled, randomized, double-blind, parallel group, phase 3 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. A separate informed consent will be allowed for an initial pre-screening genetic testing. Subjects meeting the AA genotype will then consent to the full study and confirmatory genetic testing as required. Subject enrollment may begin in the hospital and will continue following release from the hospital or may begin following release from 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 (up to12 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.
The 2 groups in the trial
- DalcetrapibTreatment being tested
Dalcetrapib 600 mg (two 300 mg tablets) orally once daily
- PlaceboPlacebo, for comparison
Matching dalcetrapib placebo tablets (2 tablets) orally once per day
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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)
- Plain-language title
- Tests dalcetrapib against placebo in people with a recent heart attack-related conditionGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 22 June 2026