Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS
Recruiting
Phase 3Interventional Study
Acute Coronary Syndrome
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
45 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
2,000 (estimated)
Sponsor
DalCor Pharmaceuticals · Industry
Who this trial is looking for
This trial is looking for people who have had a heart attack recently and have a specific genetic profile. Participants will take either the study drug or a placebo and will be monitored for their heart health.
Are You a Good Fit for This Trial?
You may be able to join if
I have had a heart attack in the last 3 months.
I am at least 45 years old.
I have a specific genetic type (AA genotype).
I am currently stable and have no symptoms at rest.
I have received appropriate treatment for my cholesterol.
You may not be able to join if
I am pregnant or breastfeeding.
I am not using effective birth control.
I have severe heart failure.
My blood pressure is too high despite treatment.
I have significant liver disease.
I have had very high creatine levels recently.
I have a history of cancer or a serious illness that affects my participation.
I had heart surgery between my heart attack and joining the study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
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Eligibility Criteria
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 determi…
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
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