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| ID | Type | Description | Link |
|---|---|---|---|
| 0407E1841 |
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| Name | Class |
|---|---|
| Shionogi | INDUSTRY |
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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | 2.5-20 mg | ||
| HMG CoA inhibitor | Drug | 3-hydroxy-3-methylglutaryl-coenzyme A |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 76 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 76 in Plaque Volume (PV) in the Target Lesion | Target Lesion indicates Coronary plaque composition of culprit lesions. | Baseline - 76Weeks |
| Percent Change From Baseline to Specified Measurement Time Points in Low-density Lipoprotein （LDL-C） |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Masunori Matsuzaki, MD | Yamaguchi University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Gifu | Japan | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22831708 | Derived | Daida H, Takayama T, Hiro T, Yamagishi M, Hirayama A, Saito S, Yamaguchi T, Matsuzaki M; COSMOS Investigators. High HbA1c levels correlate with reduced plaque regression during statin treatment in patients with stable coronary artery disease: results of the coronary atherosclerosis study measuring effects of rosuvastatin using intravascular ultrasound in Japanese subjects (COSMOS). Cardiovasc Diabetol. 2012 Jul 25;11:87. doi: 10.1186/1475-2840-11-87. |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline - 76Weeks |
| Percent Change in High-sensitivity C-reactive Protein (HS-CRP) From Baseline to Specified Measurement Time Points | Baseline - 76Weeks |
| Hamada |
| Japan |
| Research Site | Hiroshima | Japan |
| Research Site | Ichinomiya | Japan |
| Research Site | Inba-mura | Japan |
| Research Site | Izumi | Japan |
| Research Site | Izumisano | Japan |
| Research Site | Izumo | Japan |
| Research Site | Kagoshima | Japan |
| Research Site | Kanazawa | Japan |
| Research Site | Kasuga | Japan |
| Research Site | Kobe | Japan |
| Research Site | Komaki | Japan |
| Research Site | Konancho | Japan |
| Research Site | Kumamoto | Japan |
| Research Site | Kurume | Japan |
| Research Site | Kyoto | Japan |
| Research Site | Osaka | Japan |
| Research Site | Ōmiya | Japan |
| Research Site | Sapporo | Japan |
| Research Site | Shinjō | Japan |
| Research Site | Shūnan | Japan |
| Research Site | Suita | Japan |
| Research Site | Tokyo | Japan |
| Research Site | Ube | Japan |
| Research Site | Yamaguchi | Japan |
| Research Site | Yokohama | Japan |
| Observation Period |
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| Treatment Period |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | 1 participant did not receive drug and is not captured in these figures | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Percent Change | Baseline and 76 weeks |
|
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 76 in Plaque Volume (PV) in the Target Lesion | Target Lesion indicates Coronary plaque composition of culprit lesions. | Posted | Mean | Standard Deviation | mg/dL | Baseline - 76Weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline to Specified Measurement Time Points in Low-density Lipoprotein （LDL-C） | Posted | Mean | Standard Deviation | Percent change | Baseline - 76Weeks |
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| ||||||||||||||||||||||||||||
| Secondary | Percent Change in High-sensitivity C-reactive Protein (HS-CRP) From Baseline to Specified Measurement Time Points | Posted | Mean | Standard Deviation | Percent change | Baseline - 76Weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 98 | 213 | 588 | 214 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Angina Pectoris | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Angina Unstable | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Atrioventricular Block | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Cardiac Failure | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Cardiac Failure Acute | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Cardiac Failure Congestive | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Coronary Artery Perforation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Coronary Artery Stenosis | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Prinzmetal Angina | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Melaena | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Rectal Ulcer | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Oedema Peripheral | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Puncture Site Haemorrhage | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
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| Hepatic Function Abnormal | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
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| Liver Disorder | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
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| Bronchopneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Filariasis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Liver Abscess | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Brain Contusion | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Coronary Artery Restenosis | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| In-Stent Coronary Artery Restenosis | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Stent Occlusion | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Subdural Haematoma | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Alanine Aminotransferase Increased | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Aspartate Aminotransferase Increased | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Blood Alkaline Phosphatase Increased | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Blood Bilirubin Increased | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Blood Pressure Decreased | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| C-Reactive Protein Increased | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Gamma-Glutamyltransferase Increased | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Glycosylated Haemoglobin Increased | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Neutrophil Count Decreased | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Platelet Count Decreased | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Bile Duct Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
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| Large Intestine Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
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| Ovarian Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
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| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
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| Small Cell Lung Cancer Stage Unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
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| Cerebral Haemorrhage | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Cerebral Infarction | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Dysarthria | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Facial Palsy | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Hemiparesis | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Loss Of Consciousness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Thalamus Haemorrhage | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Visual Field Defect | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Haemorrhage Subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Arterial Bypass Operation | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
| |
| Coronary Angioplasty | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dental Caries | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Aspartate Aminotransferase Increased | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Blood Alkaline Phosphatase Increased | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Blood Creatine Phosphokinase Increased | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Blood Pressure Increased | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Blood Urine Present | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| C-Reactive Protein Increased | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Gamma-Glutamyltransferase Increased | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Glucose Urine Present | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Glycosylated Haemoglobin Increased | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Haematocrit Decreased | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Haemoglobin Decreased | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Protein Urine Present | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Red Blood Cell Count Decreased | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| White Blood Cell Count Increased | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Upper Respiratory Tract Inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
Because there was no placebo arm the net effect of rosuvastatin was not clarified. This study examined only single measurable plaques, which might not represent pan-coronary nature of plaque.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |
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