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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2,000
Cholesterol Ester Transfer Protein Inhibitor, 300 mg tablets
matching placebo tablets
Research Site
Alexander City, Alabama, United States
WITHDRAWNResearch Site
Birmingham, Alabama, United States
RECRUITINGResearch Site
Fairhope, Alabama, United States
RECRUITINGResearch Site
Huntsville, Alabama, United States
Time to first occurrence of any fatal or non-fatal myocardial infarction (MI)
Time to patients experiencing major cardiovascular events
Time frame: Average of 30 months from randomization
The composite of all-cause death, resuscitated cardiac arrest, non-fatal MI and non-fatal stroke
Time to patients experiencing major cardiovascular events
Time frame: Average of 30 months from randomization
Composite of all-cause death, resuscitated cardiac arrest, non-fatal MI and non-fatal stroke
Time to patients experiencing first and recurrent occurrences
Time frame: Average of 30 months from randomization
Fatal and non-fatal MI
Time to patients experiencing first and recurrent occurrences
Time frame: Average of 30 months from randomization
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Research Site
Mobile, Alabama, United States
RECRUITINGResearch Site
Scottsdale, Arizona, United States
RECRUITINGResearch Site
Tucson, Arizona, United States
RECRUITINGResearch Site
Jonesboro, Arkansas, United States
WITHDRAWNResearch Site
North Little Rock, Arkansas, United States
RECRUITINGResearch Site
Garden Grove, California, United States
WITHDRAWN...and 213 more locations