ArteriosclerosisNCT02305862
A High-Resolution Magnetic Resonance Imaging Study to Evaluate the Effect of Rosuvastatin on Carotid Atherosclerotic Plaques
A study testing Rosuvastatin 5mg and Rosuvastatin 20mg in people with Arteriosclerosis and Diabetes Mellitus, run by Capital Medical University at 1 site in China.
Trial summary
The aim of this study is to assess whether high intensive statin therapy could regress carotid atherosclerotic plaques as determined by High-Resolution Contrast Enhanced Magnetic Resonance imaging (CE-MRI). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arteriosclerosis, Diabetes Mellitus, Lipid Disorder
- What is being tested?
- Rosuvastatin 5mg and Rosuvastatin 20mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Jul 2017
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Patients with coronary artery disease or carotid atherosclerotic plaque or hyperlipideimia or old myocardial infarction
Who cannot join
- Planning coronary stenting
- Heart failure
- Uncontrolled hypertension（≥200/110mmHg)
- Uncontrolled diabetes mellitus (HbA1C≥9.5%)
- Hepatic insufficiency
- Renal dysfunction
- Cancer
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, 100050
Qiang Fu, Dr, 861067096562, fuqiang66882000@hotmail.com
Buxing Chen, Dr
About this study
Official title: An Open-label, Single-centre Randomized Study Evaluating the Effect of Treatment With Rosuvastatin 5/20mg on Atherosclerotic Disease as Measured by High-Resolution Contrast Enhanced Magnetic Resonance Imaging in Patients With Coronary Artery Disease and Hyperlipideimia
The aim of this study is to assess whether high intensive statin therapy could regress carotid atherosclerotic plaques as determined by High-Resolution Contrast Enhanced Magnetic Resonance imaging (CE-MRI).
Enrolled patients have a baseline CE-MRI examination for screening carotid atherosclerotic plaques and are randomized to either low dose of Rosuvastatin (5mg) group or high dose of Rosuvastatin (20mg) group. After 26 weeks, all patients received CE-MRI examination again and each pair of baseline and follow-up CE-MRI assessments was analyzed in a blinded fashion. Moreover, lipid level and major adverse cardiovascular events are also evaluated during follow-up.
- Conditions
- Arteriosclerosis, Diabetes Mellitus, Lipid Disorder
- Being tested
- Rosuvastatin 5mg, Rosuvastatin 20mg
- Keywords
- Coronary Arteriosclerosis, Carotid Atherosclerotic Plaque, Rosuvastatin
- Medical subject headings
- Arteriosclerosis, Diabetes Mellitus, Lipid Metabolism Disorders, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin 5mgDrug
drug intervention
Rosuvastatin 20mgDrug
drug intervention
| Study group | Role | What they receive |
|---|---|---|
| low dose group (5mg) | Experimental | low dose Rosuvastatin Receives: Drug: Rosuvastatin 5mg |
| high dose group (20mg) | Experimental | high dose Rosuvastatin Receives: Drug: Rosuvastatin 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate whether 26 weeks of treatment with 5/20mg rosuvastatin results in regression of carotid atherosclerotic plaques as measured by CE-MRI
Measured: 26 weeks
Secondary outcomes (5)
major adverse cardiovascular events
Measured: 26 weeks
To evaluate the change in lipid and lipoprotein levels as assessed by percentage change from baseline.
Measured: 26 weeks
To evaluate the change from baseline in liver function (AST/ALT) at 26 weeks
Measured: 26 weeks
To evaluate the change from baseline in renal function (serum creatine) at 26 weeks
Measured: 26 weeks
To evaluate the change from baseline in creatine kinase at 26 weeks
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startJan 2013
- Primary completionDec 2016 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArteriosclerosisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buxing Chen, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305862
- Sponsor's protocol ID
- AMARIROCAP
- Status last verified
- Jul 2016
- First submitted
- 26 Nov 2014
- Last updated
- 21 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-centre Randomized Study Evaluating the Effect of Treatment With Rosuvastatin 5/20mg on Atherosclerotic Disease as Measured by High-Resolution Contrast Enhanced Magnetic Resonance Imaging in Patients With Coronary Artery Disease and Hyperlipideimia
- ClinicalTrials.gov ID
- NCT02305862
- Acronym / sponsor ID
- AMARIROCAP
- Conditions
- Arteriosclerosis, Diabetes Mellitus, Lipid Disorder
- Keywords
- Coronary Arteriosclerosis, Carotid Atherosclerotic Plaque, Rosuvastatin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 3 Dec 2014 (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 aim of this study is to assess whether high intensive statin therapy could regress carotid atherosclerotic plaques as determined by High-Resolution Contrast Enhanced Magnetic Resonance imaging (CE-MRI).
Enrolled patients have a baseline CE-MRI examination for screening carotid atherosclerotic plaques and are randomized to either low dose of Rosuvastatin (5mg) group or high dose of Rosuvastatin (20mg) group. After 26 weeks, all patients received CE-MRI examination again and each pair of baseline and follow-up CE-MRI assessments was analyzed in a blinded fashion. Moreover, lipid level and major adverse cardiovascular events are also evaluated during follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low dose group (5mg) | Experimental | Drug: Rosuvastatin 5mglow dose Rosuvastatin |
| high dose group (20mg) | Experimental | Drug: Rosuvastatin 20mghigh dose Rosuvastatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Patients with coronary artery disease or carotid atherosclerotic plaque or hyperlipideimia or old myocardial infarction
Key exclusion criteria (7 listed)
- Planning coronary stenting
- Heart failure
- Uncontrolled hypertension（≥200/110mmHg)
- Uncontrolled diabetes mellitus (HbA1C≥9.5%)
- Hepatic insufficiency
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 5mgdrug intervention | Drug | low dose group (5mg) |
| Rosuvastatin 20mgdrug intervention | Drug | high dose group (20mg) |
Primary outcome
To evaluate whether 26 weeks of treatment with 5/20mg rosuvastatin results in regression of carotid atherosclerotic plaques as measured by CE-MRI
Time frame: 26 weeks
5 secondary outcomes
major adverse cardiovascular events
Time frame: 26 weeks
To evaluate the change in lipid and lipoprotein levels as assessed by percentage change from baseline.
Time frame: 26 weeks
To evaluate the change from baseline in liver function (AST/ALT) at 26 weeks
Time frame: 26 weeks
To evaluate the change from baseline in renal function (serum creatine) at 26 weeks
Time frame: 26 weeks
To evaluate the change from baseline in creatine kinase at 26 weeks
Time frame: 26 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2016.
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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 study testing Rosuvastatin 5mg and Rosuvastatin 20mg in people with Arteriosclerosis and Diabetes Mellitus, run by Capital Medical University 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 1 inclusion and 7 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 21 Jul 2016. 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.
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 Buxing Chen, MD, Ph.D (861067096572, chbux@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate whether 26 weeks of treatment with 5/20mg rosuvastatin results in regression of carotid atherosclerotic plaques as measured by CE-MRI (time frame: 26 weeks). 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 21 Jul 2016.