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AdminiStration of Statin On Acute Ischemic stRoke patienT Trial

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02549846
Acronym
ASSORT
Enrollment
270
Registered
2015-09-15
Start date
2015-09-30
Completion date
2017-03-31
Last updated
2018-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

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.

Interventions

DRUGStatin

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

Sponsors

Shionogi
CollaboratorINDUSTRY
Hyogo Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
modified Rankin Scale12 weeks from stroke onsetScale range from 0 \[no symptom\] to 6 \[dead\]

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026