NCT02532309

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
308

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 25, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Last Updated

August 28, 2015

Status Verified

August 1, 2015

Enrollment Period

3 years

First QC Date

July 30, 2015

Last Update Submit

August 26, 2015

Conditions

Carotid Atherosclerosis

Keywords

RosuvastatinCarotid Atherosclerosis plaqueCrestorRosuvastatin calcium

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (7)

  • Total Carotid Plaque Area

    Baseline to 12 months and 24 months

  • Carotid Intima-Media Thickness(IMT)

    Baseline to 12 months and 24 months

  • The level of Blood lipid

    baseline and 1, 2, 3, 6, 12, 18, 24 months post-dose

  • Low density lipoprotein-cholesterol (LDL-c)

    Baseline to 12 months and 24 months

  • Carotid Intima-Media Thickness(IMT)

    Up to 24 months

  • +2 more secondary outcomes

Study Arms (2)

Rosuvastatin dose adjustment

EXPERIMENTAL
Drug: Rosuvastatin (5mg，10mg，20mg)

Rosuvastatin fixed dose

EXPERIMENTAL
Drug: Rosuvastatin 5mg

Interventions

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.

Rosuvastatin dose adjustment
Rosuvastatin 5mgDRUG

Rosuvastatin 5mg/day

Rosuvastatin fixed dose

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Carotid Artery Diseases

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Cao Fei

CONTACT

86-10-56259183frank.cao@clinstech-med.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending Doctor

Study Record Dates

First Submitted

July 30, 2015

First Posted

August 25, 2015

Study Start

April 1, 2015

Primary Completion

April 1, 2018

Last Updated

August 28, 2015

Record last verified: 2015-08

Locations

CN(1)