NCT00654394

Brief Summary

The purpose of this study is to examine the changes in the carotid artery when subjects receive high or low doses of rosuvastatin.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2000

Longer than P75 for phase_3

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2008

Completed
Last Updated

March 16, 2009

Status Verified

March 1, 2009

First QC Date

April 3, 2008

Last Update Submit

March 13, 2009

Conditions

Carotid Artery StenosisHypercholesterolemia

Keywords

CholesterolCarotid Artery StenosisHypercholesterolemiaRosuvastatinCrestor

Outcome Measures

Primary Outcomes (1)

  • Changes in carotid wall volume as measured by MRI scan

    At 40 weeks and 104 weeks

Secondary Outcomes (2)

  • Safety: adverse events & abnormal laboratory markers

    2 weekly for first 4 weeks then 4 weekly

  • Other changes in the structure and composition of the carotid arterial wall as defined in the protocol.

    At 40 weeks and 104 weeks

Study Arms (1)

1

EXPERIMENTAL
Drug: Rosuvastatin

Interventions

RosuvastatinDRUG
Also known as: Crestor
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fasting blood low density lipoprotein cholesterol level as defined by the protocol
  • Diagnosed carotid arterial stenosis

You may not qualify if:

  • The use of lipid lowering drugs or dietary supplements after Visit 1.
  • Heavy or total occlusion of the carotid artery or recent stroke
  • Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Clezar CN, Flumignan CD, Cassola N, Nakano LC, Trevisani VF, Flumignan RL. Pharmacological interventions for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2023 Aug 4;8(8):CD013573. doi: 10.1002/14651858.CD013573.pub2.

    PMID: 37565307DERIVED

MeSH Terms

Conditions

Carotid StenosisHypercholesterolemia

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Tom Hatsukami

    University of Washington, USA

    PRINCIPAL INVESTIGATOR

  • Russell Esterline

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 3, 2008

First Posted

April 8, 2008

Study Start

January 1, 2000

Study Completion

August 1, 2004

Last Updated

March 16, 2009

Record last verified: 2009-03