AdminiStration of Statin On Acute Ischemic stRoke patienT Trial (ASSORT)

February 26, 2018 updated by: Shinichi Yoshimura, Hyogo College of Medicine

Randomized Controlled Trial of Early Versus Late Statin Therapy in Patients With Ischemic Stroke

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

270

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Hyogo
      • Nishinomiya, Hyogo, Japan, 665-8501
        • Hyogo collage of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Acute Group
Atorvastatin 20 mg or Pitavastain 4 mg or Rosuvastatin 5 mg treatment initiated within 24 hours after admission
Drug: Statin
Randomized controlled trial of early versus late statin therapy in patients with ischemic stroke
Other Names:
  • Atorvastatin, Pitavastain, Rosuvastatin
Other: Stable Group
Not start or withdraw Atorvastatin 20 mg or Pitavastain 4 mg or Rosuvastatin 5 mg treatment for a weak after admission.
Drug: Statin
Randomized controlled trial of early versus late statin therapy in patients with ischemic stroke
Other Names:
  • Atorvastatin, Pitavastain, Rosuvastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
modified Rankin Scale
Time Frame: 12 weeks from stroke onset
Scale range from 0 [no symptom] to 6 [dead]
12 weeks from stroke onset

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hyogo College of Medicine

Collaborators

Shionogi

Investigators

  • Principal Investigator: Shinichi Yoshimura, Hyogo collage of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

August 11, 2015

First Submitted That Met QC Criteria

September 13, 2015

First Posted (Estimate)

September 15, 2015

Study Record Updates

Last Update Posted (Actual)

February 27, 2018

Last Update Submitted That Met QC Criteria

February 26, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMIN000021032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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