A Study to Evaluate the Efficacy and Safety of Rosuvastatin in the Treatment of the Carotid Atherosclerotic Plaques
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|ClinicalTrials.gov Identifier: NCT02532309|
Recruitment Status : Unknown
Verified August 2015 by Wei Liu, China-Japan Friendship Hospital.
Recruitment status was: Recruiting
First Posted : August 25, 2015
Last Update Posted : August 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Carotid Atherosclerosis||Drug: Rosuvastatin (5mg，10mg，20mg) Drug: Rosuvastatin 5mg||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||308 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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 Atherosclerotic Plaques|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||April 2018|
|Experimental: Rosuvastatin dose adjustment||
Drug: Rosuvastatin (5mg，10mg，20mg)
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.
|Experimental: Rosuvastatin fixed dose||
Drug: Rosuvastatin 5mg
- Total Carotid Plaque Area [ Time Frame: Up to 24 months ]A comparison of the change in total Carotid Plaques area from the two treatment groups examined by color Doppler ultrasound.
- Total Carotid Plaque Area [ Time Frame: Up to 12 months ]Reversal of total Carotid Atherosclerosis Plaques in the two rosuvastatin dose group at 12 months.
- Total Carotid Plaque Area [ Time Frame: Baseline to 12 months and 24 months ]Changes from baseline in total Carotid Atherosclerosis Plaques (TPA) from the two rosuvastatin treatment groups from baseline at 12 months and 24 months.
- Carotid Intima-Media Thickness(IMT) [ Time Frame: Baseline to 12 months and 24 months ]Changes of Carotid Intima-Media Thickness (IMT) in the two rosuvastatin treatment groups from baseline to 12 months and to 24 months.
- The level of Blood lipid [ Time Frame: baseline and 1, 2, 3, 6, 12, 18, 24 months post-dose ]Changes from baseline in the level of Blood lipid from the two rosuvastatin treatment groups.
- Low density lipoprotein-cholesterol (LDL-c) [ Time Frame: Baseline to 12 months and 24 months ]Analysis of the corrlation between LDL-c and TPA from the two rosuvastatin treatment groups.
- Carotid Intima-Media Thickness(IMT) [ Time Frame: Up to 24 months ]Analysis of the corrlation between IMT and TPA in each treatment group.
- Incidence of Adverse Events [ Time Frame: Baseline to 24 months ]The categories and incidences of Adverse Events from the two treatment groups.
- Incidences of Major Adverse Cardiovascular and Cerebrovascular Events（MACCE） [ Time Frame: Baseline to 24 months ]Incidences of Major adverse cardiovascular and cerebrovascular events from the two rosuvastatin treatment groups.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02532309
|Contact: Cao Feifirstname.lastname@example.org|