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A Time-window StratifiedRandomised, Open-label, Controlled, Multicentered Phase IIa Trial to Assess the Efficacy and Safety of Thrombolysis with Recombinant Human Prourokinase in the patients with Acute Acute Ischaemic Stroke

Trial Profile

A Time-window StratifiedRandomised, Open-label, Controlled, Multicentered Phase IIa Trial to Assess the Efficacy and Safety of Thrombolysis with Recombinant Human Prourokinase in the patients with Acute Acute Ischaemic Stroke

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 05 Dec 2023

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At a glance

  • Drugs Saruplase (Primary)
  • Indications Ischaemic stroke
  • Focus Therapeutic Use
  • Acronyms rhpro-UK STROKEIIa
  • Sponsors Shanghai Tasly Pharmaceutical

Most Recent Events

  • 29 Nov 2023 Primary endpoint [modified Rankin scale (mRS) score Group A (rhPro-UK 50 mg) vs Group B (rhPro-UK 35 mg) assessed 4.5h to 6h of AIS onset] has not been met as per results published in the CNS Drugs.
  • 29 Nov 2023 Results (n= 80) of this trial evaluating therapeutic effects and safety of intravenous recombinant human prourokinase (rhPro-UK) in patients with acute ischemic stroke (AIS) in the 4.5-6 h therapeutic time windows published in the CNS Drugs.
  • 08 Feb 2019 Preliminary results presented at the International Stroke Conference 2019

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