Coronary Heart Disease
Conditions
Brief summary
This study will assess the effect of RO4607381, compared to placebo, on atherosclerotic plaque in patients with coronary heart disease (CHD) including patients with other CHD risk factors. After a pre-randomisation period during which positron emission tomography computed tomography (PET/CT) and MRI will be conducted, patients will be randomized to receive either RO4607381 600mg po daily, or placebo po daily. PET/CT and MRI scans will be taken at intervals during the study. The anticipated time on study treatment is 2 years, and the target sample size is 100 individuals.
Interventions
600mg po daily for 24 months
DRUGPlacebo
po daily for 24 months
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* adult patients, 18-75 years of age; * CHD, including patients with other CHD risk factors; * treated appropriately for dyslipidemia; * clinically stable.
Exclusion criteria
* previous exposure to any cholesteryl ester transfer protein (CETP) inhibitor or vaccine; * recent (within 3 months) clinically significant coronary events, transient ischemic attacks or cerebrovascular accident; * severe anemia; * uncontrolled hypertension; * poorly controlled diabetes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change From Baseline in Mean Wall Thickness | 24 months |
| Change From Baseline in Target (Plaque) to Background (Blood) Ratio From an Index Vessel. | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Blood Lipids,Lipoproteins | Throughout study |
| Change From Baseline in Vessel Magnetic Resonance (MR) Determined Compliance | 6 months |
| CHD, Major Coronary Events, Adverse Events (AEs), Lab Parameters, Blood Pressure | Throughout study |
| Biomarkers | Up to 24 months |
| Change From Baseline in Vessel MR Determined Plaque Anatomy | Up to 24 months |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dalcetrapib (RO4607381) Dalcetrapib (RO4607381): 600mg po daily for 24 months | 64 |
| Placebo Placebo: po daily for 24 months | 66 |
| Total | 130 |
Baseline characteristics
| Characteristic | Placebo | Total | Dalcetrapib (RO4607381) |
|---|---|---|---|
| Age, Continuous | 64.6 years STANDARD_DEVIATION 7.8 | 63.6 years STANDARD_DEVIATION 1 | 62.6 years STANDARD_DEVIATION 8.24 |
| Region of Enrollment Canada | 8 participants | 16 participants | 8 participants |
| Region of Enrollment United States | 58 participants | 114 participants | 56 participants |
| Sex: Female, Male Female | 55 Participants | 106 Participants | 51 Participants |
| Sex: Female, Male Male | 11 Participants | 24 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 64 | 0 / 66 |
| serious Total, serious adverse events | 20 / 64 | 19 / 66 |
Outcome results
Primary
Change From Baseline in Target (Plaque) to Background (Blood) Ratio From an Index Vessel.
Time frame: 6 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Dalcetrapib (RO4607381) | Change From Baseline in Target (Plaque) to Background (Blood) Ratio From an Index Vessel. | -0.188 Ratio | Standard Error 0.078 |
| Placebo | Change From Baseline in Target (Plaque) to Background (Blood) Ratio From an Index Vessel. | -0.260 Ratio | Standard Error 0.079 |
Primary
Percent Change From Baseline in Mean Wall Thickness
Time frame: 24 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Dalcetrapib (RO4607381) | Percent Change From Baseline in Mean Wall Thickness | 4.245 Percent Change | Standard Error 3.018 |
| Placebo | Percent Change From Baseline in Mean Wall Thickness | 6.679 Percent Change | Standard Error 3.111 |
Secondary
Biomarkers
Time frame: Up to 24 months
Population: Data not collected
Secondary
Blood Lipids,Lipoproteins
Time frame: Throughout study
Population: Data not collected
Secondary
Change From Baseline in Vessel Magnetic Resonance (MR) Determined Compliance
Time frame: 6 months
Population: Data not collected
Secondary
Change From Baseline in Vessel MR Determined Plaque Anatomy
Time frame: Up to 24 months
Population: Data not collected
Secondary
CHD, Major Coronary Events, Adverse Events (AEs), Lab Parameters, Blood Pressure
Time frame: Throughout study
Population: Data not collected