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| Name | Class |
|---|---|
| University of Washington | OTHER |
| AstraZeneca | INDUSTRY |
| Beijing Clinstech-med consulting Co., Ltd | OTHER |
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This is a 2-year, open-label, randomized study to evaluate the efficacy of Rosuvastatin dosing adjustment by LDL-C level compared to that of 5mg maintenance dose in chinese patients with Carotid Atherosclerosis.
This will be a 2-year, randomized, open-label, prospective, parallel-group study. It only be held in China-Japan Friendship Hospital. Subjects with Carotid Atherosclerosis Plaques who meet all inclusion and none of the exclusion criteria will be randomized in a 1:1 ratio to receive treatment of rosuvastatin (5 mg, 10mg, 20mg) dosing adjustment by LDL-c level or fixed dose 5 mg. The study will consist of two phases: the Screening/Baseline period(-1to week 0)and the Follow-up period(0 to month 24). The follow-up period will comprise seven visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin dose adjustment | Experimental |
| |
| Rosuvastatin fixed dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin (5mg,10mg,20mg) | Drug | Rosuvastatin dose adjusted by LDL-c level( If LDL-C>1.1mmol/L and <1.8mmol/L, administrated as 5mg/day.If LDL-C ≥1.8mmol/L, adjusted every 4 weeks as 5mg,10mg,20mg. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Carotid Plaque Area | A comparison of the change in total Carotid Plaques area from the two treatment groups examined by color Doppler ultrasound. | Up to 24 months |
| Total Carotid Plaque Area | Reversal of total Carotid Atherosclerosis Plaques in the two rosuvastatin dose group at 12 months. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total Carotid Plaque Area | Changes from baseline in total Carotid Atherosclerosis Plaques (TPA) from the two rosuvastatin treatment groups from baseline at 12 months and 24 months. | Baseline to 12 months and 24 months |
| Carotid Intima-Media Thickness(IMT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cao Fei | Contact | 86-10-56259183 | frank.cao@clinstech-med.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Rosuvastatin 5mg | Drug | Rosuvastatin 5mg/day |
|
Changes of Carotid Intima-Media Thickness (IMT) in the two rosuvastatin treatment groups from baseline to 12 months and to 24 months. |
| Baseline to 12 months and 24 months |
| The level of Blood lipid | Changes from baseline in the level of Blood lipid from the two rosuvastatin treatment groups. | baseline and 1, 2, 3, 6, 12, 18, 24 months post-dose |
| Low density lipoprotein-cholesterol (LDL-c) | Analysis of the corrlation between LDL-c and TPA from the two rosuvastatin treatment groups. | Baseline to 12 months and 24 months |
| Carotid Intima-Media Thickness(IMT) | Analysis of the corrlation between IMT and TPA in each treatment group. | Up to 24 months |
| Incidence of Adverse Events | The categories and incidences of Adverse Events from the two treatment groups. | Baseline to 24 months |
| Incidences of Major Adverse Cardiovascular and Cerebrovascular Events(MACCE) | Incidences of Major adverse cardiovascular and cerebrovascular events from the two rosuvastatin treatment groups. | Baseline to 24 months |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |