AdminiStration of Statin On Acute Ischemic stRoke patienT Trial

Ischemic Stroke Clinical Trial

— ASSORT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02549846
• Other study ID #: UMIN000021032
• Status: Completed
• Phase: Phase 4
• First received: August 11, 2015
• Last updated: February 26, 2018
• Start date: September 2015
• Est. completion date: March 2017

Study information

• Verified date: February 2018
• Source: Hyogo College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Statin
Randomized controlled trial of early versus late statin therapy in patients with ischemic stroke

Locations

Country	Name	City	State
Japan	Hyogo collage of Medicine	Nishinomiya	Hyogo

Sponsors (2)

Lead Sponsor	Collaborator
Hyogo College of Medicine	Shionogi

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified Rankin Scale	Scale range from 0 [no symptom] to 6 [dead]	12 weeks from stroke onset