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Post-Marketing Clinical Study of Alteplase for Acute Ischemic Stroke (Japan Alteplase Clinical Trial Ⅱ:J-ACT Ⅱ)

2014-08-27 03:41:05 | BioPortfolio

Summary

The purpose of this study is to confirm the efficacy and safety of intravenously administered alteplase in patients with acute ischemic stroke based on the rate of recanalization assessed by magnetic resonance angiography (MRA), the rate of patients with a modified Rankin Scale (mRS) score of 0-1, and the incidence of symptomatic intracranial hemorrhage (sICH), in comparison with the data reported in the current literature.

Study Design

Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Stroke

Intervention

Alteplase

Status

Completed

Source

Mitsubishi Tanabe Pharma Corporation

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:41:05-0400

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Medical and Biotech [MESH] Definitions

Restoration of functions to the maximum degree possible in a person or persons suffering from a stroke.

Stroke caused by lacunar infarction or other small vessel diseases of the brain. It features hemiparesis (see PARESIS), hemisensory, or hemisensory motor loss.

A group of pathological conditions characterized by sudden, non-convulsive loss of neurological function due to BRAIN ISCHEMIA or INTRACRANIAL HEMORRHAGES. Stroke is classified by the type of tissue NECROSIS, such as the anatomic location, vasculature involved, etiology, age of the affected individual, and hemorrhagic vs. non-hemorrhagic nature. (From Adams et al., Principles of Neurology, 6th ed, pp777-810)

A condition caused by the failure of body to dissipate heat in an excessively hot environment or during PHYSICAL EXERTION in a hot environment. Contrast to HEAT EXHAUSTION, the body temperature in heat stroke patient is dangerously high with red, hot skin accompanied by DELUSIONS; CONVULSIONS; or COMA. It can be a life-threatening emergency and is most common in infants and the elderly.

A strain of Rattus norvegicus with elevated blood pressure used as a model for studying hypertension and stroke.

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