A 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): the dal-302 (dal-gene-2) trial.
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Une étude de phase III, en double aveugle, randomisée contrôlée par placebo pour évaluer les effets du dalcétrapib sur le risque cardiovasculaire (CV) dans une population génétiquement définie avec un Syndrome Coronarien Aigu (SCA) récent : L'essai DAL-302 (dal-GenE-2).
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. ACS is defined as the occurrence of at least one of the following events:
- Myocardial Infarction (MI): Spontaneous MI (Types 1, 2 and 3) / Procedure-Related MI after Percutaneous Coronary Intervention (PCI) (Type 4a)
-Hospitalization for ACS (ECG Abnormalities without Biomarkers).
In addition, the following inclusion criteria apply:
1. Both male and female subjects age 45 years and over at screening visit (V1)
2. Signed informed consent (approved by Institutional Review Board [IRB]/Independent Ethics Committee [IEC]) obtained prior to any study specific screening procedures. Separate consent forms will be allowed for genetic screening and for full study participation.
3. AA genotype at variant rs 1967309 in the ADCY9 gene as determined by the investigational use only version of the cobas® ADCY9 Genotype Test, conducted at a designated investigational testing site (ITS)
4. Clinically stable, ie, free of ischemic symptoms at rest or with minimal exertion for at least 1 week prior to randomization including completion of planned revascularization procedures.5. Prior to randomization, subjects must have evidence of guidelines-based management of LDL-C, at a minimum to include medical and dietary treatment.
6. Randomization within 3 months of the index ACS event
Exclusion criteria
1. Females who are pregnant (negative urine pregnancy test required for all women of child-bearing potential at Visit 2, Day 0) or breast-feeding
2. 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 with a failure rate of <1%. These are defined as hormonal contraception associated with inhibition of ovulation, intrauterine devices (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, and sexual abstinence for the full duration of the study where abstinence is the preferred and usual lifestyle of the subject.
3. New York Heart Association (NYHA) Class III or IV heart failure
4. Index ACS event presumed due to uncontrolled hypertension
5. Systolic blood pressure (BP) >180 mmHg and/or diastolic blood pressure >110 mmHg at the time of randomization despite anti-hypertensive therapy
6. 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)
7. History of persistent and unexplained creatine phosphokinase (CPK) levels > 5 times the ULN as assessed within 6 months prior to randomization (excluding index event)
8. Last known eGFR < 30 mL/min/1.73m2 as assessed within 6 months prior to randomization
9. 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.
10. 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
11. Current alcohol or drug abuse or history thereof within 2 years prior to screening that would likely interfere with compliance, based on investigator assessment
12. 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
13. Subjects unable or unwilling to comply with protocol requirements, or deemed by the investigator to be unfit for the study
14. Subjects who have undergone coronary artery bypass graft (CABG) surgery between the index event and randomization
Cohorts
Proposed Therapy or Intervention
Intervention
médicament
Cohorts
Centre intégré de santé et de services sociaux de la Montérégie-Centre
Data not available
Current data since :
May 07, 2024 00:15
Centre intégré universitaire de santé et de services sociaux du Nord-de-l’Île-de-Montréal
Data not available
Current data since :
April 05, 2024 11:35
Centre hospitalier Universitaire de Québec
Data not available
Current data since :
April 05, 2024 11:35
Centre intégré de santé et de services sociaux de Laval
Data not available
Current data since :
March 06, 2024 08:50
Centre hospitalier universitaire de Sherbrooke
Data not available
Current data since :
February 20, 2024 00:31
Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec
Data not available
Current data since :
November 16, 2023 00:30
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Data not available
Current data since :
October 17, 2023 17:53
Centre intégré de santé et de services sociaux de Lanaudière
Data not available
Current data since :
December 23, 2023 00:32
Centre universitaire de santé McGill
Data not available
Current data since :
December 07, 2023 00:31
Centre hospitalier de l'Université de Montréal
Data not available
Current data since :
March 25, 2024 00:15
Institut de cardiologie de Montréal
Data not available
Current data since :
May 07, 2024 00:15
Centre intégré de santé et de services sociaux des Laurentides
Data not available
Current data since :
December 20, 2023 00:33
other centers
Name
Medical condition
Treatment
Recruitment status
Dalcetrapib
Dalcetrapib 600 mg (two 300 mg tablets) orally once daily
Data not available
Unknown
Placebo
Matching dalcetrapib placebo tablets (2 tablets) orally once per day
Data not available
Unknown
Dalcetrapib
Recruitment status
unknown
Dalcetrapib 600 mg (two 300 mg tablets) orally once daily
Placebo
Recruitment status
unknown
Matching dalcetrapib placebo tablets (2 tablets) orally once per day
Current data since :
May 06, 2024 20:00
Study's description
Study description
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.
This is an event-driven study and will last until approximately 200 subjects have experienced a primary event, unless the study is stopped at the planned interim analysis. Visits after randomization will be performed as virtual visits where permissible every 3 months or as clinic visits until the study is stopped. For any subject prematurely discontinuing study medication, assessments will be conducted every 3 months for the collection of study endpoints.
Those who are likely to qualify will undergo Genotype Assay Testing to evaluate genetic determination or the presence of the AA genotype at variant rs 1967309 in the ADCY9 gene as determined by the investigational use only version of the cobas ADCY9 Genotype Test, conducted at a designated investigational testing site.
