AdminiStration of Statin On Acute Ischemic stRoke patienT Trial

NCT ID: NCT02549846

Last Updated: 2018-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Acute Group

Atorvastatin 20 mg or Pitavastain 4 mg or Rosuvastatin 5 mg treatment initiated within 24 hours after admission

Group Type ACTIVE_COMPARATOR

Statin

Intervention Type DRUG

Randomized controlled trial of early versus late statin therapy in patients with ischemic stroke

Stable Group

Not start or withdraw Atorvastatin 20 mg or Pitavastain 4 mg or Rosuvastatin 5 mg treatment for a weak after admission.

Group Type OTHER

Statin

Intervention Type DRUG

Randomized controlled trial of early versus late statin therapy in patients with ischemic stroke

Interventions

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Statin

Randomized controlled trial of early versus late statin therapy in patients with ischemic stroke

Intervention Type DRUG

Other Intervention Names

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Atorvastatin, Pitavastain, Rosuvastatin

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shionogi

INDUSTRY

Sponsor Role collaborator

Hyogo Medical University

OTHER

Sponsor Role lead

Responsible Party

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Shinichi Yoshimura

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shinichi Yoshimura

Role: PRINCIPAL_INVESTIGATOR

Hyogo collage of Medicine

Locations

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Hyogo collage of Medicine

Nishinomiya, Hyōgo, Japan

Site Status

Countries

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Japan

References

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Yoshimura S, Uchida K, Daimon T, Takashima R, Kimura K, Morimoto T; ASSORT Trial Investigator. Randomized Controlled Trial of Early Versus Delayed Statin Therapy in Patients With Acute Ischemic Stroke: ASSORT Trial (Administration of Statin on Acute Ischemic Stroke Patient). Stroke. 2017 Nov;48(11):3057-3063. doi: 10.1161/STROKEAHA.117.017623. Epub 2017 Oct 13.

Reference Type DERIVED
PMID: 29030478 (View on PubMed)

Other Identifiers

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UMIN000021032

Identifier Type: -

Identifier Source: org_study_id

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