1. Safety and Efficacy of Otaplimastat in Patients with Acute Ischemic Stroke Requiring tPA (SAFE‐TPA): A Multicenter, Randomized, Double‐Blind, Placebo‐Controlled Phase 2 Study
- Author
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Byung Su Kim, Eun-Jae Lee, Yang-Ha Hwang, Eung-Gyu Kim, Jei-Man Ryu, Jong Ho Park, Chung Ju, Jong S. Kim, Dae-Il Chang, Kyungmi Oh, Sang Min Sung, Kyung Bok Lee, and Won-Ki Kim
- Subjects
Adult ,Male ,0301 basic medicine ,Placebo ,Brain Ischemia ,law.invention ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Double-Blind Method ,Fibrinolytic Agents ,Randomized controlled trial ,law ,Modified Rankin Scale ,Multicenter trial ,Acetamides ,medicine ,Humans ,Adverse effect ,Stroke ,Research Articles ,Aged ,Quinazolinones ,Aged, 80 and over ,Intracerebral hemorrhage ,business.industry ,Middle Aged ,medicine.disease ,Neuroprotective Agents ,Treatment Outcome ,030104 developmental biology ,Neurology ,Tissue Plasminogen Activator ,Anesthesia ,Administration, Intravenous ,Female ,Chills ,Neurology (clinical) ,medicine.symptom ,business ,030217 neurology & neurosurgery ,Research Article - Abstract
Objective Otaplimastat is a neuroprotectant that inhibits matrix metalloprotease pathway, and reduces edema and intracerebral hemorrhage induced by recombinant tissue plasminogen activator (rtPA) in animal stroke models. We aimed to assess the safety and efficacy of otaplimastat in patients receiving rtPA. Methods This was a phase 2, 2‐part, multicenter trial in stroke patients (19–80 years old) receiving rtPA. Intravenous otaplimastat was administered
- Published
- 2019
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