A Study to Evaluate the Efficacy and Safety of Rosuvastatin in the Treatment of the Carotid Atherosclerotic Plaques

Phase 4

• Conditions: Carotid Atherosclerosis
• Interventions: Drug: Rosuvastatin (5mg，10mg，20mg); Drug: Rosuvastatin 5mg

• Registration Number: NCT02532309
• Lead Sponsor: Wei Liu

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-07-30
• Status Verified: 2015-08
• Study First Submitted QC: 2015-08-21
• Study First Posted: 2015-08-25
• Last Update Submitted: 2015-08-26
• Last Update Posted: 2015-08-28
• Primary Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 308

Inclusion Criteria

• Subjects or legal guardian can understand and sign the written informed consent form;
• LDL-C≥100mg/dl（2.6mmol/l）.
• Subjects with carotid atherosclerotic non-calcified plaques determined by color Doppler ultrasound on carotid. ( Plaque defined as limited intima media thickness≥1.5mm, according to the procedure of vascular ultrasound examination in 2009 Chinese Journal of Ultrasonography )
• Subjects had not been treated with statins, or one had been treated with antihyperlipidemics no more than 3 months within 12 months prior to screening.

Exclusion Criteria

• Subjects known to be allergic to the study medication, or any components .
• Uncontrolled hypothyroidism defined as the systolic blood pressure(SBP) >180 mmHg or the diastolic blood pressure(DBP) >100 mmHg.
• Concomitant with severe or frequent arrhythmia, such as Atrial Fibrillation, second or third degree Atrioventricular Block, Sick sinus Syndrome etc.
• Alanine aminotransaminase (ALT) and /or Aspartate aminotransferase (AST) >1.5×ULN (upper limit of normal).
• Subjects with myopathies，or the value of Creatine kinase >1.5×ULN (upper limit of normal).
• Concomitant with chronic wasting diseases, whose life span was anticipated no longer than 2 years.
• Pregnant or nursing woman, and subjects with a Pregnant plan during this study.
• Cognitive impairment, which may affect obtaining informed consent and participating in the study procedures.
• Unwilling to receive treatment or examinations outlined in protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rosuvastatin dose adjustment	Rosuvastatin (5mg，10mg，20mg)	-
Rosuvastatin fixed dose	Rosuvastatin 5mg	-

Primary Outcome Measures

Name	Time	Method
Total Carotid Plaque Area	Up to 12 months	Reversal of total Carotid Atherosclerosis Plaques in the two rosuvastatin dose group at 12 months.

Secondary Outcome Measures

Name	Time	Method
The level of Blood lipid	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.
Total Carotid Plaque Area	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)	Up to 24 months	Analysis of the corrlation between IMT and TPA in each treatment group.
Low density lipoprotein-cholesterol (LDL-c)	Baseline to 12 months and 24 months	Analysis of the corrlation between LDL-c and TPA from the two rosuvastatin treatment groups.
Incidence of Adverse Events	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）	Baseline to 24 months	Incidences of Major adverse cardiovascular and cerebrovascular events from the two rosuvastatin treatment groups.

Trial Locations

Locations (1)

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China