Last updated on June 2019

Safety and Efficacy of NA-1 in Subjects Undergoing Endovascular Thrombectomy for Stroke (ESCAPE-NA1)


Brief description of study

The ESCAPE-NA-1 study is designed to determine the safety and efficacy of the neuroprotectant, NA-1, in reducing global disability in subjects with major acute ischemic stroke (AIS) with a small established infarct core and with good collateral circulation who are selected for endovascular revascularization.

Detailed Study Description

Trial Objectives:

The primary objective is to determine the efficacy of the neuroprotectant, NA-1, in reducing global disability in subjects with major acute ischemic stroke (AIS) with a small established infarct core and with good collateral circulation selected for rapid endovascular revascularization.

The secondary objectives are to determine the efficacy of NA-1 in:

  • Reducing functional dependence
  • Improving neurological outcome
  • Improving activities of daily living
  • Reducing mortality rate The leading safety objectives are to determine the effect of administering a dose of 2.6 mg/kg (up to a maximum dose of 270 mg) intravenous (IV) infusion of NA-1 to subject with acute stroke who are selected for endovascular revascularization on serious adverse events (SAEs) and 90-day mortality.

Trial Design:

This study is a Phase 3, randomized, multicentre, blinded, placebo-controlled, parallel group, single-dose design. Subjects harboring an acute ischemic stroke and who are selected for endovascular revascularization in accordance with local institutional practices and who harbor a small established infarct core and with good collateral circulation will be given a single, 2.6 mg/kg (up to a maximum dose of 270 mg) intravenous dose of NA-1 or placebo as soon as they are deemed to have met the enrollment criteria and with the intention of starting administration within 30 minutes of randomization. The randomization will be by stochastic minimization to balance baseline factors.

Clinical Study Identifier: NCT02930018

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Royal Victoria Hospital

Belfast, United Kingdom
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Ronald Reagan UCLA Medical Center

Los Angeles, CA United States
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Swedish Medical Center

Englewood, CO United States
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Yale New Haven Hospital

New Haven, CT United States
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Baptist Health Medical Center

Jacksonville, FL United States
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Grady Memorial Hospital

Atlanta, GA United States
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WellStar Health Systems

Marietta, GA United States
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NYU Lutheran Medical Center

Brooklyn, NY United States
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Novant Health Forsyth Medical Center

Winston-Salem, NC United States
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Riverside Radiology

Columbus, OH United States
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Abington Memorial Hospital

Philadelphia, PA United States
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UPMC Presbyterian

Pittsburgh, PA United States
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Rhode Island Hospital

Providence, RI United States
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Valley Baptist Medical Center

Harlingen, TX United States
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Dongsan Medical Centre

Daegu, Korea, Republic of
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Inha University Hospital

Incheon, Korea, Republic of
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Samsung Medical Center

Seoul, Korea, Republic of
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Yonsei Univ, Severence

Seoul, Korea, Republic of
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Recruitment Status: Open


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