AtherosclerosisPhase 4NCT02594800
Intensive Rosuvastatin Therapy on Cerebral Hemodynamics in Patients With Atherosclerotic Intracranial Arterial Stenosis
A Phase 4 study testing Rosuvastatin in people with Atherosclerosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Atherosclerotic intracranial arterial stenosis (AICAS) corresponds to luminal narrowing of the major intracranial arteries. The prevalence of intracranial atherosclerotic stenosis accounts for 33% to 67% of stroke or transient ischemic attack (TIA) cases in China and other countries in Asia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 21 Dec 2015to 30 Jun 2019
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent
- Male and female adults aged 18-80years old
- Recent (within 3 months) ischemic stroke or TIA;
- Intracranial large artery (intracranial internal artery, middle cerebral artery M1, vertebral artery and basilar artery) stenosis between 50-99%.
- Statin naïve:defined as receiving no statin therapy within 3 months
Who cannot join
- Cardioembolic stroke;
- Rosuvastatin use is contraindicated;
- Allergic to contrast agents;
- Chronic devastating illness, multiple organ failure;
- Dementia or mental disorder unable to return for repeat brain CTP.
- Administration of lipid-lowering drugs (statin, clofibrate, probucol or analog, nicotinic acid, or other prohibited drug) before enrollment.
- Active liver disease or aminopherase ≧3 ULN(Upper Limit of Normal)
- Renal function damage. GFR（Glomerular Filtration Rate） ﹤30ml/min
Trial locations and contacts
1 site in 1 country.
China1 site
The second affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
Official title: The Impact of Intensive Rosuvastatin Therapy on Cerebral Hemodynamics in Patients With Atherosclerotic Intracranial Arterial Stenosis Evaluated by Computed Tomography Perfusion (CTP)
Atherosclerotic intracranial arterial stenosis (AICAS) corresponds to luminal narrowing of the major intracranial arteries. The prevalence of intracranial atherosclerotic stenosis accounts for 33% to 67% of stroke or transient ischemic attack (TIA) cases in China and other countries in Asia. AICAS is also highly associated with the risk of stroke recurrence. Possible mechanisms of cerebral infarction secondary to AICAS are likely linked with hemodynamic compromise distal to site of stenosis.
Computed tomography perfusion (CTP) can be used to evaluate vasoreactivity and cerebrovascular reserve in patients with AICAS and predict future stroke. The parameters of CTP include ①cerebral blood flow(CBF),② cerebral blood volume(CBV) and ③mean transit time(MTT). Relative regional cerebral blood flow (rCBF) was evaluated as the percentage radioisotope counts in the region of interest (ROI) of the affected side against the corresponding ROI in the unaffected contralateral side.
Read more
Statins can decrease the incidence of transient ischemic attack or ischemic stroke and improve stroke outcome. Few studies focus on the relationship between statins therapy and cerebral perfusion.
Whether intensive rosuvastatin therapy compared with standard rosuvastatin therapy can improve hemodynamic situation and cerebral perfusion status in AICAS has not been illustrated.
Based on those studies, the investigators hypothesized that intensive rosuvastatin may also improve the symptoms of AICAS not only through enhancing the stability of atherosclerotic plaques, but also its pleiotropic effects. So it can change the hemodynamic status around the plaque and increase cerebral flow in the downstream territory. So in this study the investigators try to analysis statin's impact on the hemodynamic changes as well as the downstream perfusion which is determined by CTP.
Read the detailed description
This is an prospective, randomized, single-blind, single center clinical trial to evaluate the effect of intensive rosuvastatin therapy compared with standard rosuvastatin therapy on improve the cerebral perfusion in Chinese patients with atherosclerotic intracranial arterial stenosis between 50-99%.
The study will enroll 44 patients and randomly divided into 2 groups: standard dose rosuvastatin therapy (SRT 10mg/day)and intensive dose rosuvastatin therapy (IRT 20mg/day)in a 1:1 ratio. Both groups will be prescribed with statin based on other routine medication for stroke for 52 weeks. CTP will be performed at baseline and 52 weeks after treatment. Lipid levels and biochemical examinations will be obtained at baseline and 13, 26, 39, 52 week. AEs(Adverse Events)/SAEs(Serious Adverse Events) will be collected and recorded in CRF(Case Report Form) from the signing of informed consent throughout the study until and including the last visit.
Study Endpoints: Primary endpoint: Compared with standard dose rosuvastatin therapy 10mg/day, the change of relative cerebral blood flow (CBF) by CTP after intensive dose rosuvastatin therapy 20mg/day treatment for 52 weeks.Secondary endpoints: (1) Compared with standard dose rosuvastatin therapy 10mg/day, the changes of relative cerebral blood volume (CBV) by CTP after rosuvastatin 20mg/d treatment for 52 weeks (2) Compared with standard dose rosuvastatin therapy 10mg/day, the changes of relative mean transit time (MTT) by CTP after rosuvastatin 20mg/d treatment for 52 weeks (3) Compared with standard dose rosuvastatin therapy 10mg/day, the changes of lipid parameters (LDL-C, HDL-C, TG(Triglyceride), TC(Total Cholesterol), Apo A and Apo B ) after rosuvastatin 20mg/d for 52 weeks (4) Safety.
- Conditions
- Atherosclerosis
- Being tested
- Rosuvastatin
- Keywords
- Atherosclerotic Intracranial Arterial Stenosis, Intensive Rosuvastatin Therapy, Computed Tomography Perfusion (CTP)
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Crestor
standard or intensive dose rosuvastatin therapy based on other routine medication for stroke for 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| standard dose | Active comparator | Drug: Rosuvastatin rosuvastatin 10 mg daily for 52 weeks. Receives: Drug: Rosuvastatin |
| intensive dose | Experimental | Drug: Rosuvastatin rosuvastatin 20 mg daily for 52 weeks. Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of relative cerebral blood flow (CBF) （ml/100g/min）by CTP
Measured: 52 weeks
Secondary outcomes (4)
the changes of relative cerebral blood volume (CBV)（ml/100g） by CTP
Measured: 52 weeks
the changes of relative mean transit time (MTT)（min） by CTP
Measured: 52 weeks
the changes of lipid parameters (LDL-C,mmol/L；HDL-C,mmol/L；TG,mmol/L；TC,mmol/L；Apo A，mmol/L；Apo B，mmol/L )
Measured: 13, 26, 39, 52 week
myopathic events, hepatic function, renal function and other adverse events.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study start21 Dec 2015
- Primary completion12 Jul 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Lou, Ph.D, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594800
- Sponsor's protocol ID
- ESR-14-10688
- Status last verified
- Jun 2019
- First submitted
- 30 Oct 2015
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Intensive Rosuvastatin Therapy on Cerebral Hemodynamics in Patients With Atherosclerotic Intracranial Arterial Stenosis Evaluated by Computed Tomography Perfusion (CTP)
- ClinicalTrials.gov ID
- NCT02594800
- Acronym / sponsor ID
- ESR-14-10688
- Conditions
- Atherosclerosis
- Keywords
- Atherosclerotic Intracranial Arterial Stenosis, Intensive Rosuvastatin Therapy, Computed Tomography Perfusion (CTP)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 21 Dec 2015 (actual)
- Primary completion
- 12 Jul 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 3 Nov 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.
Atherosclerotic intracranial arterial stenosis (AICAS) corresponds to luminal narrowing of the major intracranial arteries. The prevalence of intracranial atherosclerotic stenosis accounts for 33% to 67% of stroke or transient ischemic attack (TIA) cases in China and other countries in Asia. AICAS is also highly associated with the risk of stroke recurrence. Possible mechanisms of cerebral infarction secondary to AICAS are likely linked with hemodynamic compromise distal to site of stenosis.
Computed tomography perfusion (CTP) can be used to evaluate vasoreactivity and cerebrovascular reserve in patients with AICAS and predict future stroke. The parameters of CTP include ①cerebral blood flow(CBF),② cerebral blood volume(CBV) and ③mean transit time(MTT). Relative regional cerebral blood flow (rCBF) was evaluated as the percentage radioisotope counts in the region of interest (ROI) of the affected side against the corresponding ROI in the unaffected contralateral side.
Statins can decrease the incidence of transient ischemic attack or ischemic stroke and improve stroke outcome. Few studies focus on the relationship between statins therapy and cerebral perfusion.
Whether intensive rosuvastatin therapy compared with standard rosuvastatin therapy can improve hemodynamic situation and cerebral perfusion status in AICAS has not been illustrated.
Based on those studies, the investigators hypothesized that intensive rosuvastatin may also improve the symptoms of AICAS not only through enhancing the stability of atherosclerotic plaques, but also its pleiotropic effects. So it can change the hemodynamic status around the plaque and increase cerebral flow in the downstream territory. So in this study the investigators try to analysis statin's impact on the hemodynamic changes as well as the downstream perfusion which is determined by CTP.
Detailed description
This is an prospective, randomized, single-blind, single center clinical trial to evaluate the effect of intensive rosuvastatin therapy compared with standard rosuvastatin therapy on improve the cerebral perfusion in Chinese patients with atherosclerotic intracranial arterial stenosis between 50-99%.
The study will enroll 44 patients and randomly divided into 2 groups: standard dose rosuvastatin therapy (SRT 10mg/day)and intensive dose rosuvastatin therapy (IRT 20mg/day)in a 1:1 ratio. Both groups will be prescribed with statin based on other routine medication for stroke for 52 weeks. CTP will be performed at baseline and 52 weeks after treatment. Lipid levels and biochemical examinations will be obtained at baseline and 13, 26, 39, 52 week. AEs(Adverse Events)/SAEs(Serious Adverse Events) will be collected and recorded in CRF(Case Report Form) from the signing of informed consent throughout the study until and including the last visit.
Study Endpoints: Primary endpoint: Compared with standard dose rosuvastatin therapy 10mg/day, the change of relative cerebral blood flow (CBF) by CTP after intensive dose rosuvastatin therapy 20mg/day treatment for 52 weeks.Secondary endpoints: (1) Compared with standard dose rosuvastatin therapy 10mg/day, the changes of relative cerebral blood volume (CBV) by CTP after rosuvastatin 20mg/d treatment for 52 weeks (2) Compared with standard dose rosuvastatin therapy 10mg/day, the changes of relative mean transit time (MTT) by CTP after rosuvastatin 20mg/d treatment for 52 weeks (3) Compared with standard dose rosuvastatin therapy 10mg/day, the changes of lipid parameters (LDL-C, HDL-C, TG(Triglyceride), TC(Total Cholesterol), Apo A and Apo B ) after rosuvastatin 20mg/d for 52 weeks (4) Safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard dose | Active comparator | Drug: RosuvastatinDrug: Rosuvastatin rosuvastatin 10 mg daily for 52 weeks. |
| intensive dose | Experimental | Drug: RosuvastatinDrug: Rosuvastatin rosuvastatin 20 mg daily for 52 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of informed consent
- Male and female adults aged 18-80years old
- Recent (within 3 months) ischemic stroke or TIA;
- Intracranial large artery (intracranial internal artery, middle cerebral artery M1, vertebral artery and basilar artery) stenosis between 50-99%.
- Statin naïve:defined as receiving no statin therapy within 3 months
Key exclusion criteria (8 listed)
- Cardioembolic stroke;
- Rosuvastatin use is contraindicated;
- Allergic to contrast agents;
- Chronic devastating illness, multiple organ failure;
- Dementia or mental disorder unable to return for repeat brain CTP.
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: Crestorstandard or intensive dose rosuvastatin therapy based on other routine medication for stroke for 52 weeks. | Drug | intensive dose, standard dose |
Primary outcome
the change of relative cerebral blood flow (CBF) （ml/100g/min）by CTP
Time frame: 52 weeks
4 secondary outcomes
the changes of relative cerebral blood volume (CBV)（ml/100g） by CTP
Time frame: 52 weeks
the changes of relative mean transit time (MTT)（min） by CTP
Time frame: 52 weeks
the changes of lipid parameters (LDL-C,mmol/L；HDL-C,mmol/L；TG,mmol/L；TC,mmol/L；Apo A，mmol/L；Apo B，mmol/L )
Time frame: 13, 26, 39, 52 week
myopathic events, hepatic function, renal function and other adverse events.
Time frame: 52 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 31 Mar 2020.
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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.
Min Lou, Ph.D principal investigator
Zhejiang University
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 in people with Atherosclerosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 5 inclusion and 8 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 31 Mar 2020. 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?
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?
the change of relative cerebral blood flow (CBF) （ml/100g/min）by CTP (time frame: 52 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 31 Mar 2020.