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Clinical Trials in Canada / NCT05918861
Recruiting Phase 3

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

NCT05918861 · tracked via the Priya Life Science Canada tracker
Sponsor
DalCor Pharmaceuticals
Phase
Phase 3
Started
2023-10-03
Last updated
2026-06-22

Condition(s) studied

Acute Coronary Syndrome

Investigational drug(s) / intervention(s)

DalcetrapibPlacebo

Dalcetrapib: Cholesterol Ester Transfer Protein Inhibitor, 300 mg tablets

Placebo: matching placebo tablets

Study summary

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.

Eligibility

Sex
ALL
Min age
45 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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. * 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 * 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 * 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 investigator 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 * Subjects who have undergone coronary artery bypass graft (CABG) surgery between the index event and randomization

Primary outcome measure(s)

Trial sites (231)

FacilityCityRegionStatus
Research Site Alexander City Alabama Withdrawn
Research Site Birmingham Alabama Recruiting
Research Site Fairhope Alabama Recruiting
Research Site Huntsville Alabama Recruiting
Research Site Mobile Alabama Recruiting
Research Site Scottsdale Arizona Recruiting
Research Site Tucson Arizona Recruiting
Research Site Jonesboro Arkansas Withdrawn
Research Site North Little Rock Arkansas Recruiting
Research Site Garden Grove California Withdrawn
Research Site Huntington Beach California Recruiting
Research Site La Jolla California Recruiting
Research Site Long Beach California Withdrawn
Research Site Los Angeles California Withdrawn
Research Site Newport Beach California Not Yet Recruiting
Research Site Newport Beach California Not Yet Recruiting
Research Site San Francisco California Recruiting
Research Site Santa Barbara California Recruiting
Research Site Stanford California Recruiting
Research Site Torrance California Recruiting
Research Site West Hills California Recruiting
Research Site Aurora Colorado Recruiting
Research Site Golden Colorado Recruiting
Research Site Hartford Connecticut Recruiting
Research Site New Haven Connecticut Recruiting
Research Site Newark Delaware Recruiting
Research Site Washington D.C. District of Columbia Recruiting
Research Site Boca Raton Florida Withdrawn
Research Site Boca Raton Florida Terminated
Research Site Clearwater Florida Recruiting
Research Site Doral Florida Not Yet Recruiting
Research Site Fort Lauderdale Florida Recruiting
Research Site Fort Myers Florida Recruiting
Research Site Gainesville Florida Not Yet Recruiting
Research Site Hialeah Florida Withdrawn
Research Site Homestead Florida Recruiting
Research Site Jacksonville Florida Recruiting
Research Site Kissimmee Florida Withdrawn
Research Site Largo Florida Recruiting
Research Site Miami Florida Recruiting

+ 191 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05918861 on ClinicalTrials.gov ↗ ← All trials in Canada