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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02549846
Recruitment Status : Completed
First Posted : September 15, 2015
Last Update Posted : February 27, 2018
Sponsor:
Collaborator:
Shionogi
Information provided by (Responsible Party):
Shinichi Yoshimura, Hyogo Medical University

Study Description
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Brief Summary:
Investigators will study whether immediate statin treatment after the onset of stroke is beneficial on the neurological protection

Condition or disease Intervention/treatment Phase
Ischemic Stroke Drug: Statin Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Early Versus Late Statin Therapy in Patients With Ischemic Stroke
Actual Study Start Date : September 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Atorvastatin, Pitavastain, Rosuvastatin
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 Name: Atorvastatin, Pitavastain, Rosuvastatin


Outcome Measures
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Primary Outcome Measures :
  1. modified Rankin Scale [ Time Frame: 12 weeks from stroke onset ]
    Scale range from 0 [no symptom] to 6 [dead]


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02549846


Locations
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Japan
Hyogo collage of Medicine
Nishinomiya, Hyogo, Japan, 665-8501
Sponsors and Collaborators
Hyogo Medical University
Shionogi
Investigators
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Principal Investigator: Shinichi Yoshimura Hyogo collage of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Shinichi Yoshimura, Principal Investigator, Hyogo Medical University
ClinicalTrials.gov Identifier: NCT02549846    
Other Study ID Numbers: UMIN000021032
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
 Brain Ischemia
Infarction
Necrosis
Atorvastatin
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors