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

Description

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.

Conditions

Acute Coronary Syndrome

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Study Overview

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Study Details

Study overview

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.

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)

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

Condition
Acute Coronary Syndrome
Intervention / Treatment

-

Contacts and Locations

Alexander City

Research Site, Alexander City, Alabama, United States, 35010

Birmingham

Research Site, Birmingham, Alabama, United States, 35211

Fairhope

Research Site, Fairhope, Alabama, United States, 36532

Huntsville

Research Site, Huntsville, Alabama, United States, 35801

Mobile

Research Site, Mobile, Alabama, United States, 36608

Scottsdale

Research Site, Scottsdale, Arizona, United States, 85258

Tucson

Research Site, Tucson, Arizona, United States, 85724

Jonesboro

Research Site, Jonesboro, Arkansas, United States, 72405

North Little Rock

Research Site, North Little Rock, Arkansas, United States, 72117

Garden Grove

Research Site, Garden Grove, California, United States, 92844

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

45 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

DalCor Pharmaceuticals,

David Kallend, MBBS, STUDY_DIRECTOR, DalCor

Study Record Dates

2027-08