Testing Dalcetrapib against a placebo for acute coronary syndrome
Official title: Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS
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)
Interventions
Dalcetrapib
Cholesterol Ester Transfer Protein Inhibitor, 300 mg tablets
Placebo
matching placebo tablets
Canadian Sites (43)
Research Site
Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Abbotsford British Columbia, British Columbia, Canada
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Burnaby, British Columbia, Canada
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Kamloops, British Columbia, Canada
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North Vancouver, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Moncton, New Brunswick, Canada
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Moncton, New Brunswick, Canada
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St. John's, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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Brampton, Ontario, Canada
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Cambridge, Ontario, Canada
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Kingston, Ontario, Canada
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London, Ontario, Canada
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Newmarket, Ontario, Canada
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Ottawa, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Granby, Quebec, Canada
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Greenfield Park, Quebec, Canada
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Laval, Quebec, Canada
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Lévis, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Québec, Quebec, Canada
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Rimouski, Quebec, Canada
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Saint-Charles-Borromée, Quebec, Canada
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Saint-Hubert, Quebec, Canada
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Saint-Jérôme, Quebec, Canada
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Terrebonne, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Sherbrooke, Quebec City, Canada
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Saskatoon, Saskatchewan, Canada
Eligibility Criteria
See who this study is looking for18 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Subjects with the appropriate genetic background and recently hospitalized for ACS (up to 3 months following the index event), will be enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in this trial.
- +Both male and female subjects age 45 years and over at screening visitScreeningThe checks done before joining, to see whether a study fits.Read more → (V1)
- +AA genotype at variant gene as determined by Genotype Assay Test, conducted at a designated investigational testing siteTrial siteA hospital or clinic where a study is actually run.Read more → (ITS)
- +Clinically stable, ie, free of ischemic symptoms at rest or with minimal exertion for at least 1 week prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
- +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
Exclusion
- −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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → (excluding index event)
- −New York Heart Association (NYHA) Class III or IV heart failure
- −Index ACS event presumed due to uncontrolled hypertension
- −Systolic blood pressure (BP) \>180 mmHg and/or diastolic blood pressure \>110 mmHg at the time of randomization despite anti-hypertensive therapy
- −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
- −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.
- −Presence of any last known laboratory value as evaluated prior to randomization that is considered by the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → to potentially limit the patient's successful participation in the study
- −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
- −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.
- −Subjects who have undergone coronary artery bypass graft (CABG) surgery between the index event and randomization
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: Dalcetrapib, PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 45 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 2,000 people.
The study is currently expected to finish around August 2027.
The main measurement is taken over: Average of 30 months from randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Time to first occurrence of any fatal or non-fatal myocardial infarction (MI) — measured over Average of 30 months from randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05918861 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About DalcetrapibDrug
Cholesterol Ester Transfer Protein Inhibitor, 300 mg tablets
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
matching placebo tablets
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 45 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 45 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Average of 30 months from randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
The study as a whole is currently expected to finish around 2027-08.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 2,000 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 58 locations, including: Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Abbotsford British Columbia, British Columbia, Canada; Burnaby, British Columbia, Canada; Kamloops, British Columbia, Canada; North Vancouver, British Columbia, Canada, and 52 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (24)
Research Site
Bay City, Michigan, United States
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Dearborn, Michigan, United States
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Detroit, Michigan, United States
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Kalamazoo, Michigan, United States
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Lansing, Michigan, United States
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Midland, Michigan, United States
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Mount Clemens, Michigan, United States
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Petoskey, Michigan, United States
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Traverse City, Michigan, United States
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Ypsilanti, Michigan, United States
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Coon Rapids, Minnesota, United States
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Duluth, Minnesota, United States
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Minneapolis, Minnesota, United States
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Minneapolis, Minnesota, United States
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Saint Cloud, Minnesota, United States
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Albany, New York, United States
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Buffalo, New York, United States
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Johnson City, New York, United States
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New York, New York, United States
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Poughkeepsie, New York, United States
And 4 more sites worldwide.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.