AdminiStration of Statin On Acute Ischemic stRoke patienT Trial

NCT02549846 | Completed Phase 4 DMC

• 1 other identifier: UMIN000021032
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• modified Rankin Scale

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

  12 weeks from stroke onset

Study Arms (2)

Acute Group

ACTIVE COMPARATOR

Atorvastatin 20 mg or Pitavastain 4 mg or Rosuvastatin 5 mg treatment initiated within 24 hours after admission

Drug: Statin

Stable Group

OTHER

Not start or withdraw Atorvastatin 20 mg or Pitavastain 4 mg or Rosuvastatin 5 mg treatment for a weak after admission.

Drug: Statin

Interventions

Statin DRUG

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

Also known as: Atorvastatin, Pitavastain, Rosuvastatin

Acute Group; Stable Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hyogo Medical University: lead
• Shionogi: collaborator

Study Sites (1)

Hyogo collage of Medicine

Nishinomiya, Hyōgo, 665-8501, Japan

Location

Related Publications (1)

• 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.

  PMID: 29030478 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines

Study Officials

• Shinichi Yoshimura

  Hyogo collage of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 11, 2015
• First Posted: September 15, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: February 27, 2018

Record last verified: 2018-02

Locations

JP (1)