Trial Outcomes & Findings for Rosuvastatin in the Long-term Treatment of Hypercholesterolaemic Subjects With Coronary Heart Disease (NCT NCT00329160)
NCT ID: NCT00329160
Last Updated: 2011-08-31
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
214 participants
Primary outcome timeframe
Baseline and 76 weeks
Results posted on
2011-08-31
Participant Flow
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
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
214
|
|
Overall Study
Observation Period
|
214
|
|
Overall Study
Treatment Period
|
214
|
|
Overall Study
COMPLETED
|
126
|
|
Overall Study
NOT COMPLETED
|
88
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Adverse Event
|
27
|
|
Overall Study
Withdrawal by Subject
|
13
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Did not Receive Study Drug
|
1
|
|
Overall Study
Incomplete IVUS
|
45
|
Baseline Characteristics
Rosuvastatin in the Long-term Treatment of Hypercholesterolaemic Subjects With Coronary Heart Disease
Baseline characteristics by cohort
| Measure |
Rosuvastatin
n=126 Participants
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.
|
|---|---|
|
Age Continuous
Years
|
62.6 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
96 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 76 weeksPlaque 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.
Outcome measures
| Measure |
Rosuvastatin
n=126 Participants
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.
|
|---|---|
|
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 outcome
Timeframe: Baseline - 76WeeksTarget Lesion indicates Coronary plaque composition of culprit lesions.
Outcome measures
| Measure |
Rosuvastatin
n=126 Participants
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.
|
|---|---|
|
Change From Baseline to Week 76 in Plaque Volume (PV) in the Target Lesion
|
12.074 mg/dL
Standard Deviation -5.259
|
SECONDARY outcome
Timeframe: Baseline - 76WeeksOutcome measures
| Measure |
Rosuvastatin
n=126 Participants
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.
|
|---|---|
|
Percent Change From Baseline to Specified Measurement Time Points in Low-density Lipoprotein （LDL-C）
|
16.9 Percent change
Standard Deviation -38.6
|
SECONDARY outcome
Timeframe: Baseline - 76WeeksOutcome measures
| Measure |
Rosuvastatin
n=126 Participants
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.
|
|---|---|
|
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
|
Adverse Events
Rosuvastatin
Serious events: 98 serious events
Other events: 588 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rosuvastatin
n=214 participants at risk；n=213 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.47%
1/213
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.47%
1/213
|
|
Cardiac disorders
Angina Pectoris
|
3.3%
7/213
|
|
Cardiac disorders
Angina Unstable
|
0.47%
1/213
|
|
Cardiac disorders
Atrioventricular Block
|
0.47%
1/213
|
|
Cardiac disorders
Cardiac Failure
|
0.47%
1/213
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.47%
1/213
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.94%
2/213
|
|
Cardiac disorders
Coronary Artery Perforation
|
0.47%
1/213
|
|
Cardiac disorders
Coronary Artery Stenosis
|
9.9%
21/213
|
|
Cardiac disorders
Prinzmetal Angina
|
0.94%
2/213
|
|
Eye disorders
Cataract
|
0.47%
1/213
|
|
Gastrointestinal disorders
Enterocolitis
|
0.47%
1/213
|
|
Gastrointestinal disorders
Melaena
|
0.47%
1/213
|
|
Gastrointestinal disorders
Rectal Ulcer
|
0.47%
1/213
|
|
General disorders
Oedema Peripheral
|
0.47%
1/213
|
|
General disorders
Puncture Site Haemorrhage
|
0.47%
1/213
|
|
General disorders
Pyrexia
|
0.94%
2/213
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.47%
1/213
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
0.94%
2/213
|
|
Hepatobiliary disorders
Liver Disorder
|
0.47%
1/213
|
|
Infections and infestations
Bronchopneumonia
|
0.47%
1/213
|
|
Infections and infestations
Cellulitis
|
0.47%
1/213
|
|
Infections and infestations
Filariasis
|
0.47%
1/213
|
|
Infections and infestations
Liver Abscess
|
0.47%
1/213
|
|
Injury, poisoning and procedural complications
Brain Contusion
|
0.47%
1/213
|
|
Injury, poisoning and procedural complications
Coronary Artery Restenosis
|
0.94%
2/213
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.47%
1/213
|
|
Injury, poisoning and procedural complications
In-Stent Coronary Artery Restenosis
|
0.94%
2/213
|
|
Injury, poisoning and procedural complications
Stent Occlusion
|
0.47%
1/213
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.94%
2/213
|
|
Injury, poisoning and procedural complications
Alanine Aminotransferase Increased
|
0.47%
1/213
|
|
Injury, poisoning and procedural complications
Aspartate Aminotransferase Increased
|
0.47%
1/213
|
|
Injury, poisoning and procedural complications
Blood Alkaline Phosphatase Increased
|
0.47%
1/213
|
|
Injury, poisoning and procedural complications
Blood Bilirubin Increased
|
0.47%
1/213
|
|
Injury, poisoning and procedural complications
Blood Pressure Decreased
|
0.47%
1/213
|
|
Injury, poisoning and procedural complications
C-Reactive Protein Increased
|
0.94%
2/213
|
|
Injury, poisoning and procedural complications
Gamma-Glutamyltransferase Increased
|
0.47%
1/213
|
|
Injury, poisoning and procedural complications
Glycosylated Haemoglobin Increased
|
0.47%
1/213
|
|
Injury, poisoning and procedural complications
Neutrophil Count Decreased
|
0.47%
1/213
|
|
Injury, poisoning and procedural complications
Platelet Count Decreased
|
0.47%
1/213
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.94%
2/213
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.47%
1/213
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile Duct Cancer
|
0.47%
1/213
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large Intestine Carcinoma
|
0.47%
1/213
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer
|
0.47%
1/213
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.94%
2/213
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small Cell Lung Cancer Stage Unspecified
|
0.47%
1/213
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.47%
1/213
|
|
Nervous system disorders
Cerebral Infarction
|
0.94%
2/213
|
|
Nervous system disorders
Dysarthria
|
0.47%
1/213
|
|
Nervous system disorders
Facial Palsy
|
0.47%
1/213
|
|
Nervous system disorders
Hemiparesis
|
0.47%
1/213
|
|
Nervous system disorders
Loss Of Consciousness
|
0.47%
1/213
|
|
Nervous system disorders
Thalamus Haemorrhage
|
0.47%
1/213
|
|
Nervous system disorders
Visual Field Defect
|
0.47%
1/213
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.47%
1/213
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.47%
1/213
|
|
Skin and subcutaneous tissue disorders
Haemorrhage Subcutaneous
|
0.47%
1/213
|
|
Surgical and medical procedures
Arterial Bypass Operation
|
0.47%
1/213
|
|
Surgical and medical procedures
Coronary Angioplasty
|
0.47%
1/213
|
Other adverse events
| Measure |
Rosuvastatin
n=214 participants at risk；n=213 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
6.5%
14/214
|
|
Gastrointestinal disorders
Dental Caries
|
5.1%
11/214
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
12/214
|
|
Infections and infestations
Nasopharyngitis
|
32.2%
69/214
|
|
Infections and infestations
Alanine Aminotransferase Increased
|
17.8%
38/214
|
|
Infections and infestations
Aspartate Aminotransferase Increased
|
13.1%
28/214
|
|
Infections and infestations
Blood Alkaline Phosphatase Increased
|
9.3%
20/214
|
|
Infections and infestations
Blood Creatine Phosphokinase Increased
|
20.1%
43/214
|
|
Infections and infestations
Blood Pressure Increased
|
10.3%
22/214
|
|
Infections and infestations
Blood Urine Present
|
15.4%
33/214
|
|
Infections and infestations
C-Reactive Protein Increased
|
7.5%
16/214
|
|
Infections and infestations
Gamma-Glutamyltransferase Increased
|
22.4%
48/214
|
|
Infections and infestations
Glucose Urine Present
|
13.1%
28/214
|
|
Infections and infestations
Glycosylated Haemoglobin Increased
|
5.6%
12/214
|
|
Infections and infestations
Haematocrit Decreased
|
5.6%
12/214
|
|
Infections and infestations
Haemoglobin Decreased
|
6.5%
14/214
|
|
Infections and infestations
Protein Urine Present
|
14.5%
31/214
|
|
Infections and infestations
Red Blood Cell Count Decreased
|
5.1%
11/214
|
|
Infections and infestations
White Blood Cell Count Increased
|
5.1%
11/214
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.9%
17/214
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.1%
11/214
|
|
Nervous system disorders
Dizziness
|
8.9%
19/214
|
|
Nervous system disorders
Headache
|
5.1%
11/214
|
|
Psychiatric disorders
Insomnia
|
5.6%
12/214
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.1%
13/214
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Inflammation
|
6.5%
14/214
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.4%
18/214
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER