Clinical trial NCT02549846: AdminiStration of Statin On Acute Ischemic stRoke patienT Trial
Official title: Randomized Controlled Trial of Early Versus Late Statin Therapy in Patients With Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ischemic Stroke
Lead sponsor: Hyogo Medical University
Sponsor class: OTHER
Collaborators: name: Shionogi
First posted: 2015-09-15
Enrollment: 270
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: modified Rankin Scale
timeFrame: 12 weeks from stroke onset
Secondary outcomes:
Other outcomes:
Locations:
city: Nishinomiya
country: Japan
facility: Hyogo collage of Medicine
state: Hyogo
Study officials:
affiliation: Hyogo collage of Medicine
name: Shinichi Yoshimura
role: PRINCIPAL_INVESTIGATOR
References:
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.