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Completed

NCT Number: NCT02549846

AdminiStration of Statin On Acute Ischemic stRoke patienT Trial

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

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hyogo collage of Medicine

Nishinomiya, Hyōgo, 665-8501, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Statin

Drug

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

Other names: Atorvastatin, Pitavastain, Rosuvastatin

Primary outcomes

  1. modified Rankin Scale

    Time frame: 12 weeks from stroke onset

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

Sponsors and collaborators

Lead sponsor

Hyogo Medical University

Other

Collaborators

  • Shionogi

Registry information

Official study title

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

Acronym: ASSORT

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Sep 15, 2015
Registry last updated
Feb 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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