Carotid Artery StenosisPhase 3NCT00654394
Progression of Carotid Artery Atheroma in Moderately Hypercholesterolemic Subjects
A Phase 3 study testing Rosuvastatin in people with Carotid Artery Stenosis and Hypercholesterolemia, run by AstraZeneca.
Trial summary
The purpose of this study is to examine the changes in the carotid artery when subjects receive high or low doses of rosuvastatin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Stenosis, Hypercholesterolemia
- What is being tested?
- Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jan 2000to Aug 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fasting blood low density lipoprotein cholesterol level as defined by the protocol
- Diagnosed carotid arterial stenosis
Who cannot join
- 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
About this study
Official title: Randomized, Double-Blind, Multicenter, Trial to Assess the Effect of High & Low Doses of ZD4522 on Progression of Carotid Artery Atheroma in Moderately Hypercholesterolemic Subjects With Asymptomatic Carotid Stenosis After 24 Months of Dosing.
The purpose of this study is to examine the changes in the carotid artery when subjects receive high or low doses of rosuvastatin.
- Conditions
- Carotid Artery Stenosis, Hypercholesterolemia
- Being tested
- Rosuvastatin
- Keywords
- Cholesterol, Carotid Artery Stenosis, Hypercholesterolemia, Rosuvastatin, Crestor
- Medical subject headings
- Carotid Stenosis, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Crestor
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in carotid wall volume as measured by MRI scan
Measured: At 40 weeks and 104 weeks
Secondary outcomes (2)
Safety: adverse events & abnormal laboratory markers
Measured: 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.
Measured: At 40 weeks and 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2008 (estimated)
- Study startJan 2000
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery StenosisStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tom Hatsukami, Principal investigator, University of Washington, USARussell Esterline, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00654394
- Sponsor's protocol ID
- 4522IL/0044
- Other IDs
- D3560C00044
- Status last verified
- Mar 2009
- First submitted
- 3 Apr 2008
- Last updated
- 16 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37565307
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Multicenter, Trial to Assess the Effect of High & Low Doses of ZD4522 on Progression of Carotid Artery Atheroma in Moderately Hypercholesterolemic Subjects With Asymptomatic Carotid Stenosis After 24 Months of Dosing.
- ClinicalTrials.gov ID
- NCT00654394
- Acronym / sponsor ID
- 4522IL/0044
- Conditions
- Carotid Artery Stenosis, Hypercholesterolemia
- Keywords
- Cholesterol, Carotid Artery Stenosis, Hypercholesterolemia, Rosuvastatin, Crestor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2000
- Study completion
- Aug 2004 (actual)
- First posted
- 8 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the changes in the carotid artery when subjects receive high or low doses of rosuvastatin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Rosuvastatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fasting blood low density lipoprotein cholesterol level as defined by the protocol
- Diagnosed carotid arterial stenosis
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RosuvastatinAlso: Crestor | Drug | 1 |
Primary outcome
Changes in carotid wall volume as measured by MRI scan
Time frame: At 40 weeks and 104 weeks
2 secondary outcomes
Safety: adverse events & abnormal laboratory markers
Time frame: 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.
Time frame: At 40 weeks and 104 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2009.
- Derived from this study: PubMed 37565307Clezar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Hatsukami principal investigator
University of Washington, USA
Russell Esterline study director
AstraZeneca
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rosuvastatin in people with Carotid Artery Stenosis and Hypercholesterolemia, run by AstraZeneca.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in carotid wall volume as measured by MRI scan (time frame: At 40 weeks and 104 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00654394, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2009.