Carotid AtherosclerosisPhase 4NCT02532309
A Study to Evaluate the Efficacy and Safety of Rosuvastatin in the Treatment of the Carotid Atherosclerotic Plaques
A Phase 4 study testing Rosuvastatin (5mg，10mg，20mg) and Rosuvastatin 5mg in people with Carotid Atherosclerosis, run by Wei Liu at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Carotid Atherosclerosis
- What is being tested?
- Rosuvastatin (5mg，10mg，20mg) and Rosuvastatin 5mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to Apr 2018
- Phase
- Phase 4
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality
Liu Wei, Ph.D, 63483495@qq.com
Jiao Jinsong, Professor, jiaojinsong@aliyun.com
About this study
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
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.
Read the 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.
- Conditions
- Carotid Atherosclerosis
- Being tested
- Rosuvastatin (5mg，10mg，20mg), Rosuvastatin 5mg
- Keywords
- Rosuvastatin, Carotid Atherosclerosis plaque, Crestor, Rosuvastatin calcium
- Medical subject headings
- Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 5mgDrug
Rosuvastatin 5mg/day
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin dose adjustment | Experimental | Not described Receives: Drug: Rosuvastatin (5mg，10mg，20mg) |
| Rosuvastatin fixed dose | Experimental | Not described Receives: Drug: Rosuvastatin 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Carotid Plaque Area
A comparison of the change in total Carotid Plaques area from the two treatment groups examined by color Doppler ultrasound.
Measured: Up to 24 months
Total Carotid Plaque Area
Reversal of total Carotid Atherosclerosis Plaques in the two rosuvastatin dose group at 12 months.
Measured: Up to 12 months
Secondary outcomes (7)
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.
Measured: Baseline to 12 months and 24 months
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.
Measured: Baseline to 12 months and 24 months
The level of Blood lipid
Changes from baseline in the level of Blood lipid from the two rosuvastatin treatment groups.
Measured: baseline and 1, 2, 3, 6, 12, 18, 24 months post-dose
Low density lipoprotein-cholesterol (LDL-c)
Analysis of the corrlation between LDL-c and TPA from the two rosuvastatin treatment groups.
Measured: Baseline to 12 months and 24 months
Carotid Intima-Media Thickness(IMT)
Analysis of the corrlation between IMT and TPA in each treatment group.
Measured: Up to 24 months
Incidence of Adverse Events
The categories and incidences of Adverse Events from the two treatment groups.
Measured: Baseline to 24 months
Incidences of Major Adverse Cardiovascular and Cerebrovascular Events（MACCE）
Incidences of Major adverse cardiovascular and cerebrovascular events from the two rosuvastatin treatment groups.
Measured: Baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid AtherosclerosisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei Liu
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, AstraZeneca, Beijing Clinstech-med consulting Co., Ltd
- Responsible party
- Sponsor-investigator, Wei Liu, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532309
- Sponsor's protocol ID
- CJFH-20150203-CAP
- Status last verified
- Aug 2015
- First submitted
- 30 Jul 2015
- Last updated
- 28 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02532309
- Acronym / sponsor ID
- CJFH-20150203-CAP
- Conditions
- Carotid Atherosclerosis
- Keywords
- Rosuvastatin, Carotid Atherosclerosis plaque, Crestor, Rosuvastatin calcium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Wei LiuUniversity, hospital or other
- Collaborators
- University of Washington, AstraZeneca, Beijing Clinstech-med consulting Co., Ltd
- Study start
- Apr 2015
- Primary completion
- Apr 2018 (estimated)
- First posted
- 25 Aug 2015 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin dose adjustment | Experimental | Drug: Rosuvastatin (5mg，10mg，20mg) |
| Rosuvastatin fixed dose | Experimental | Drug: Rosuvastatin 5mg |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
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 |
|---|---|---|
| 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. | Drug | Rosuvastatin dose adjustment |
| Rosuvastatin 5mgRosuvastatin 5mg/day | Drug | Rosuvastatin fixed dose |
Primary outcome
Total Carotid Plaque Area
Time frame: Up to 24 months
A comparison of the change in total Carotid Plaques area from the two treatment groups examined by color Doppler ultrasound.
Total Carotid Plaque Area
Time frame: Up to 12 months
Reversal of total Carotid Atherosclerosis Plaques in the two rosuvastatin dose group at 12 months.
7 secondary outcomes
Total Carotid Plaque Area
Time frame: Baseline to 12 months and 24 months
Carotid Intima-Media Thickness(IMT)
Time frame: Baseline to 12 months and 24 months
The level of Blood lipid
Time frame: baseline and 1, 2, 3, 6, 12, 18, 24 months post-dose
Low density lipoprotein-cholesterol (LDL-c)
Time frame: Baseline to 12 months and 24 months
Carotid Intima-Media Thickness(IMT)
Time frame: Up to 24 months
Incidence of Adverse Events
Time frame: Baseline to 24 months
Incidences of Major Adverse Cardiovascular and Cerebrovascular Events（MACCE）
Time frame: Baseline to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin (5mg，10mg，20mg) and Rosuvastatin 5mg in people with Carotid Atherosclerosis, run by Wei Liu at 1 site in China.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 28 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cao Fei (86-10-56259183, frank.cao@clinstech-med.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Carotid Plaque Area (time frame: Up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2015.