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

Primary Purpose

Ischemic Stroke

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Statin
Sponsored by
Hyogo Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hyogo collage of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Acute Group

Stable Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

modified Rankin Scale
Scale range from 0 [no symptom] to 6 [dead]

Secondary Outcome Measures

Full Information

First Posted
August 11, 2015
Last Updated
February 26, 2018
Sponsor
Hyogo Medical University
Collaborators
Shionogi
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1. Study Identification

Unique Protocol Identification Number
NCT02549846
Brief Title
AdminiStration of Statin On Acute Ischemic stRoke patienT Trial
Acronym
ASSORT
Official Title
Randomized Controlled Trial of Early Versus Late Statin Therapy in Patients With Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hyogo Medical University
Collaborators
Shionogi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acute Group
Arm Type
Active Comparator
Arm Description
Atorvastatin 20 mg or Pitavastain 4 mg or Rosuvastatin 5 mg treatment initiated within 24 hours after admission
Arm Title
Stable Group
Arm Type
Other
Arm Description
Not start or withdraw Atorvastatin 20 mg or Pitavastain 4 mg or Rosuvastatin 5 mg treatment for a weak after admission.
Intervention Type
Drug
Intervention Name(s)
Statin
Other Intervention Name(s)
Atorvastatin, Pitavastain, Rosuvastatin
Intervention Description
Randomized controlled trial of early versus late statin therapy in patients with ischemic stroke
Primary Outcome Measure Information:
Title
modified Rankin Scale
Description
Scale range from 0 [no symptom] to 6 [dead]
Time Frame
12 weeks from stroke onset

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shinichi Yoshimura
Organizational Affiliation
Hyogo collage of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hyogo collage of Medicine
City
Nishinomiya
State/Province
Hyogo
ZIP/Postal Code
665-8501
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
29030478
Citation
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.
Results Reference
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AdminiStration of Statin On Acute Ischemic stRoke patienT Trial

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