This study will evaluate the potential of RO4607381 to reduce cardiovascular morbidity and mortality in stable coronary heart disease patients with recent Acute Coronary Syndrome (ACS) and evaluate the long term safety profile of the drug. Eligible patients in stable condition will be randomized to receive either RO4607381 600mg po or placebo po, daily, together with a background of standard medication for ACS (including aspirin, antihypertensives and statins). The anticipated time on study treatment is 2+ years, and the target sample size is 15,600 individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
15,871
Incidence of Cardiovascular Mortality and Morbidity
Number of cardiovascular events per patient per year
Time frame: From date of randomization to first event up to 48 months
Composite Endpoint:All Cause Mortality
Time frame: Throughout Study, up to 53 Months
Change From Baseline for HDL Cholesterol
Time frame: At 53 Months
Adverse Events, Lab Parameters, Vital Signs, ECG
Time frame: Throughout Study, up to 53 Months
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Tuscaloosa, Alabama, United States
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Lake Havasu City, Arizona, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
...and 1079 more locations