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The Safety and Efficacy Study of High Dose Atorvastatin After Thrombolytic Treatment in Acute Ischemic Stroke

NCT02452502 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2020-03-31

No results posted yet for this study

Summary

Emerging studies have shown that statin treatment has pleiotropic non-cholesterol-dependent effects in the setting of ischemic stroke.

Recombinant tissue plasminogen activator (rt-PA) is the only proven effective pharmaceutical treatment for hyper-acute management of ischemic stroke, in spite of the deleterious side-effects such as hemorrhagic transformation and reperfusion injury. These harmful impacts can be counteracted with proper neuro-protective therapy. In fact, the simultaneous use of an effective neuro-protective agent was proved to reduce the comorbid vascular injury of rt-PA. In experimental research, high dose of atorvastatin combined with rt-PA can significantly reduce infarct volume and improve the neurologic deficits. Previous studies showed that fewer than 40% ischemic stroke patients established early reperfusion after intravenous thrombolysis, while high dose of atorvastatin was revealed to favor the maintenance of cerebral vascular patency and integrity, most likely by reducing thrombosis secondary to rt-PA administration. Moreover, it was suggested that statin can sufficiently improve the restoration and remodeling of neurovascular unit in cerebral cortex.

Investigators thus design this study to prospectively investigate whether high dose of atorvastatin prescribed within 24 hours after IV-thrombolysis will have a synergic effect to improve neurological outcome in acute ischemic stroke patients. Moreover, investigators deemed it necessary to non-invasively monitor neuronal and vascular morphological changes in brain as an indication of functional improvement. In the investigation centers, investigators have developed and implemented novel multimodality MR imaging which can dynamically monitor neurovascular remodeling. Therefore, it is worthwhile to evaluate these MRI measurements for early prediction of neurovascular reorganization with long term functional recovery in thrombolytic stroke patients administrated with high dose of atorvastatin.

The primary target of this study is to prospectively investigate whether high dose of atorvastatin (80mg) administrated within 24 hours after IV-thrombolysis will have a synergic effect to improve neurological outcome in acute stroke patients, versus moderate dose.

Conditions

Interventions

DEVICE

atorvastatin

Atorvastatin high or moderate dose daily for 2 weeks administrated within 24 hours after receiving rt-PA thrombolysis, continued statin use for at least 12 months

Sponsors & Collaborators

  • The First Hospital of Jilin University

    collaborator OTHER

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Min Lou, Ph.D · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-02
Primary Completion
2017-11-30
Completion
2018-08-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02452502 on ClinicalTrials.gov