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

Carotid Atherosclerosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02532309
• Other study ID #: CJFH-20150203-CAP
• Status: Recruiting
• Phase: Phase 4
• First received: July 30, 2015
• Last updated: August 26, 2015
• Start date: April 2015

Study information

• Verified date: August 2015
• Source: China-Japan Friendship Hospital
• Contact: Cao Fei
• Phone: 86-10-56259183
• Email: frank.cao[@]clinstech-med.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 308
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Diseases
• Carotid Atherosclerosis
• Plaque, Atherosclerotic

Intervention

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.
• Rosuvastatin 5mg
Rosuvastatin 5mg/day

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Wei Liu	AstraZeneca, Beijing Clinstech-med consulting Co., Ltd, University of Washington

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Total Carotid Plaque Area	Reversal of total Carotid Atherosclerosis Plaques in the two rosuvastatin dose group at 12 months.	Up to 12 months	No
Secondary	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	No
Secondary	Carotid Intima-Media Thickness(IMT)	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	No
Secondary	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	No
Secondary	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	No
Secondary	Carotid Intima-Media Thickness(IMT)	Analysis of the corrlation between IMT and TPA in each treatment group.	Up to 24 months	No
Secondary	Incidence of Adverse Events	The categories and incidences of Adverse Events from the two treatment groups.	Baseline to 24 months	Yes
Secondary	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	Yes