AdminiStration of Statin On Acute Ischemic stRoke patienT Trial

Phase 4

Completed

• Conditions: Ischemic Stroke
• Interventions: Drug: Statin

• Registration Number: NCT02549846
• Lead Sponsor: Hyogo Medical University

Brief Summary

Investigators will study whether immediate statin treatment after the onset of stroke is beneficial on the neurological protection

Detailed Description

It is much more important in Japan than Western to improve the prognosis after stroke because the prevalence and mortality rate of stroke in Japan is about 3-4 times as those of acute myocardial infarction. Investigators will study whether immediate statin treatment after the onset of stroke is beneficial on the neurological protection since most of previous studies with statins just showed the preventive effects from onset of primary or recurrent cerebral infarction.

Study Timeline

• Study First Submitted: 2015-08-11
• Study Start: 2015-09
• Study First Submitted QC: 2015-09-13
• Study First Posted: 2015-09-15
• Primary Completion: 2016-12
• Study Completion: 2017-03
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-26
• Last Update Posted: 2018-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

• the Informed consent will be acquired by the document.
• Age: 20 years of age or older.
• Gender: unquestioned
• hospitalization, outpatient: hospital
• Patients by MRI at the time of hospital transport, it has been confirmed diagnosed with cerebral infarction
• ingestible in within 24 hours after admission In the study treatment period, patients that can be defined treatment in this clinical study implementation plan

Exclusion Criteria

• patients with a history of hypersensitivity to the treatment agent of the present study
• Patients acute hepatitis, chronic hepatitis acute exacerbation, liver cirrhosis, it is believed that the liver cancer, liver function jaundice or the like is reduced, or a biliary obstruction
• Patients suspected of being pregnant or pregnant
• Patients in the administration of the cyclosporine or telaprevir
• patients with moderate or severe renal impairment (SCr ≧ 2.5mg / dL or eGFR <30mg / dL)
• Patients who received a diagnosis of acute coronary syndrome within 6 months
• valvular disease, atrial fibrillation, patients with atrial thrombus
• Patients familial hypercholesterolemia
• patient admission NIHSS score is greater than or equal to 3 is more than 20 or before the onset mRS score
• patients with other doctors deemed inappropriate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acute Group	Statin	Atorvastatin 20 mg or Pitavastain 4 mg or Rosuvastatin 5 mg treatment initiated within 24 hours after admission
Stable Group	Statin	Not start or withdraw Atorvastatin 20 mg or Pitavastain 4 mg or Rosuvastatin 5 mg treatment for a weak after admission.

Primary Outcome Measures

Name	Time	Method
modified Rankin Scale	12 weeks from stroke onset	Scale range from 0 \[no symptom\] to 6 \[dead\]

Trial Locations

Locations (1)

Hyogo collage of Medicine; 🇯🇵 Nishinomiya, Hyogo, Japan