Intensive Rosuvastatin Therapy on Cerebral Hemodynamics in Patients With Atherosclerotic Intracranial Arterial Stenosis

NCT02594800 | Completed Phase 4 DMC

• 1 other identifier: ESR-14-10688
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Atherosclerosis

Keywords

Atherosclerotic Intracranial Arterial Stenosis; Intensive Rosuvastatin Therapy; Computed Tomography Perfusion (CTP)

Outcome Measures

Primary Outcomes (1)

• the change of relative cerebral blood flow (CBF) （ml/100g/min）by CTP

  52 weeks

Secondary Outcomes (4)

• the changes of relative cerebral blood volume (CBV)（ml/100g） by CTP

  52 weeks

• the changes of relative mean transit time (MTT)（min） by CTP

  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 )

  13, 26, 39, 52 week

• myopathic events, hepatic function, renal function and other adverse events.

  52 weeks

Study Arms (2)

standard dose

ACTIVE COMPARATOR

Drug: Rosuvastatin rosuvastatin 10 mg daily for 52 weeks.

Drug: Rosuvastatin

intensive dose

EXPERIMENTAL

Drug: Rosuvastatin rosuvastatin 20 mg daily for 52 weeks.

Drug: Rosuvastatin

Interventions

Rosuvastatin DRUG

standard or intensive dose rosuvastatin therapy based on other routine medication for stroke for 52 weeks.

Also known as: Crestor

intensive dose; standard dose

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Atherosclerosis

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Min Lou, Ph.D

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2015
• First Posted: November 3, 2015
• Study Start: December 21, 2015
• Primary Completion: July 12, 2018
• Study Completion: June 30, 2019
• Last Updated: March 31, 2020

Record last verified: 2019-06

Locations

CN (1)