Hypercholesteremia
Conditions
Brief summary
The primary objective of this study is to evaluate that 76 weeks of treatment with rosuvastatin calcium 2.5-20 mg results in no progression of coronary artery atherosclerotic volume as measured by intravascular ultrasonography (IVUS) imaging in hypercholesterolaemic subjects with coronary heart disease (CHD).
Interventions
DRUGRosuvastatin
2.5-20 mg
DRUGHMG CoA inhibitor
3-hydroxy-3-methylglutaryl-coenzyme A
Sponsors
AstraZeneca
Shionogi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Signed written informed consent, * 20 to 75 years old, * Plan to undergo coronary angiography (CAG) or Percutaneous coronary intervention (PCI) and LDL-C ≥ 140 mg/dL (untreated patients) or LDL-C ≥ 100 mg/dL (treated patients)
Exclusion criteria
* Acute myocardial infarction within 72 hours after the onset, * Heart failure of New York Heart Association (NYHA) Class III or above, * Serious arrhythmia, * Being treated with LDL-apheresis * History of serious reaction or hypersensitivity to other HMG-CoA reductase inhibitors.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline (Before the Start of Rosuvastatin Treatment) to Week 76 in the Plaque Volume (PV) | Baseline and 76 weeks | Plaque volume will be assessed by volumetric analysis with the echoPlaque2 system (Indec Systems Inc). Baseline and follow-up IVUS images will be reviewed side-by-side on a display, and the target segment selected. The target segment to be monitored will be determined in a non-PCI site (\>5 mm proximal or distal to the PCI site) with a reproducible index such as side branches, calcifications, or stent edges. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 76 in Plaque Volume (PV) in the Target Lesion | Baseline - 76Weeks | Target Lesion indicates Coronary plaque composition of culprit lesions. |
| Percent Change From Baseline to Specified Measurement Time Points in Low-density Lipoprotein （LDL-C） | Baseline - 76Weeks | — |
| Percent Change in High-sensitivity C-reactive Protein (HS-CRP) From Baseline to Specified Measurement Time Points | Baseline - 76Weeks | — |
Countries
Japan
Participant flow
Pre-assignment details
Observation Period :Prior to study-related activities, all subjects will sign an informed consent form. IVUS and CAG is performed prior Treatment Treatment Period: Eligible patients started treatment; rosuvastatin 2.5 mg once daily; those whose LDL-C remained \>80 mg/dl after 4 wks of treatment, the dose can be titrated to a maximum of 20 mg/day
Participants by arm
| Arm | Count |
|---|---|
| Rosuvastatin rosuvastatin 2.5 mg once daily; in those whose LDL-C remained \>80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin. | 126 |
| Total | 126 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 27 |
| Overall Study | Did not Receive Study Drug | 1 |
| Overall Study | Incomplete IVUS | 45 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Withdrawal by Subject | 13 |
Baseline characteristics
| Characteristic | Rosuvastatin |
|---|---|
| Age Continuous Years | 62.6 years STANDARD_DEVIATION 7.7 |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 96 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 588 / 214 |
| serious Total, serious adverse events | 98 / 213 |
Outcome results
Primary
Percent Change From Baseline (Before the Start of Rosuvastatin Treatment) to Week 76 in the Plaque Volume (PV)
Plaque volume will be assessed by volumetric analysis with the echoPlaque2 system (Indec Systems Inc). Baseline and follow-up IVUS images will be reviewed side-by-side on a display, and the target segment selected. The target segment to be monitored will be determined in a non-PCI site (\>5 mm proximal or distal to the PCI site) with a reproducible index such as side branches, calcifications, or stent edges.
Time frame: Baseline and 76 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosuvastatin | Percent Change From Baseline (Before the Start of Rosuvastatin Treatment) to Week 76 in the Plaque Volume (PV) | 14.1 Percent Change | Standard Deviation -5.066 |
Secondary
Change From Baseline to Week 76 in Plaque Volume (PV) in the Target Lesion
Target Lesion indicates Coronary plaque composition of culprit lesions.
Time frame: Baseline - 76Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosuvastatin | Change From Baseline to Week 76 in Plaque Volume (PV) in the Target Lesion | 12.074 mg/dL | Standard Deviation -5.259 |
Secondary
Percent Change From Baseline to Specified Measurement Time Points in Low-density Lipoprotein （LDL-C）
Time frame: Baseline - 76Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosuvastatin | Percent Change From Baseline to Specified Measurement Time Points in Low-density Lipoprotein （LDL-C） | 16.9 Percent change | Standard Deviation -38.6 |
Secondary
Percent Change in High-sensitivity C-reactive Protein (HS-CRP) From Baseline to Specified Measurement Time Points
Time frame: Baseline - 76Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosuvastatin | Percent Change in High-sensitivity C-reactive Protein (HS-CRP) From Baseline to Specified Measurement Time Points | 18.1 Percent change | Standard Deviation 291.3 |