Coronary Heart Disease
Conditions
Brief summary
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.
Interventions
600mg po daily
DRUGEvidence-based medical care for Acute Coronary Syndrome
As prescribed
DRUGPlacebo
po daily
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients, \>=45 years of age; * recently hospitalized for ACS; * clinically stable; * receiving evidence-based medical and dietary management of dyslipidemia.
Exclusion criteria
* uncontrolled diabetes; * clinically unstable; * severe anemia; * uncontrolled hypertension; * concomitant treatment with any other drug raising HDL-C (eg niacin, fibrates).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Cardiovascular Mortality and Morbidity | From date of randomization to first event up to 48 months | Number of cardiovascular events per patient per year |
Secondary
| Measure | Time frame |
|---|---|
| Composite Endpoint:All Cause Mortality | Throughout Study, up to 53 Months |
| Change From Baseline for HDL Cholesterol | At 53 Months |
| Adverse Events, Lab Parameters, Vital Signs, ECG | Throughout Study, up to 53 Months |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, Finland, France, Germany, Grenada, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Puerto Rico, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dalcetrapib (RO4607381) Dalcetrapib (RO4607381): 600mg po daily
Evidence-based medical care for Acute Coronary Syndrome: As prescribed | 7,938 |
| Placebo Evidence-based medical care for Acute Coronary Syndrome: As prescribed
Placebo: po daily | 7,933 |
| Total | 15,871 |
Baseline characteristics
| Characteristic | Dalcetrapib (RO4607381) | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 60.3 years STANDARD_DEVIATION 9.09 | 60.1 years STANDARD_DEVIATION 9.1 | 60.2 years STANDARD_DEVIATION 9.1 |
| Sex: Female, Male Female | 6365 Participants | 6436 Participants | 12801 Participants |
| Sex: Female, Male Male | 1573 Participants | 1497 Participants | 3070 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4,487 / 7,938 | 4,297 / 7,933 |
| serious Total, serious adverse events | 1,688 / 7,938 | 1,692 / 7,933 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dalcetrapib (RO4607381) | Incidence of Cardiovascular Mortality and Morbidity | 0.034050 Event per Patient Years of Followup |
| Placebo | Incidence of Cardiovascular Mortality and Morbidity | 0.032759 Event per Patient Years of Followup |
Secondary
Adverse Events, Lab Parameters, Vital Signs, ECG
Time frame: Throughout Study, up to 53 Months
Population: Data not collected
Secondary
Change From Baseline for HDL Cholesterol
Time frame: At 53 Months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Dalcetrapib (RO4607381) | Change From Baseline for HDL Cholesterol | 44.96 mg/dL | Standard Error 4.133 |
| Placebo | Change From Baseline for HDL Cholesterol | 15.60 mg/dL | Standard Error 4.102 |
Secondary
Composite Endpoint:All Cause Mortality
Time frame: Throughout Study, up to 53 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dalcetrapib (RO4607381) | Composite Endpoint:All Cause Mortality | 226 Participants |
| Placebo | Composite Endpoint:All Cause Mortality | 229 Participants |