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NCT Number: NCT03541668

Study of rhPro-UK in Patients With Acute Ischaemic Stroke in 4.5 Hours After Stroke Onset(PROST)

This is a randomized, rt-PA controlled, open-label phase 3 clinical study to evaluate the efficacy and safety of recombinant human urokinase(rhPro-UK) versus rt-PA thrombolysis for patients with acute ischaemic stroke in 4.5 hours after stroke onset.

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Key information

Conditions

Acute Ischaemic Stroke

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Luhe Hospital,Capital Medical University, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ischemic stroke with symptoms of neurological deficits.
  • Aged 18 to 80 years（including the critical value）.
  • NIH Stroke Scale（NIHSS）scores of 4 to 25（including the critical value）.
  • Treatment within 4.5 hours after stroke onset.
  • The symptoms of stroke last at least 30 minutes without significant improvement before treatment.
  • CT showed negative or signs of early infarction.
  • Informed Consent Form signed by the patients or family (legal representatives) must be provided.

Exclusion criteria

  • Patients with premorbid modified Rankin Scale (mRS) score ≥2
  • CT showed multiple infarctions（low density> 1/3 cerebral hemisphere）.
  • Transient ischemic attack.
  • Epileptic seizure after stroke.
  • Intracranial tumor, arteriovenous malformation and aneurysm.
  • Iatrogenic Stroke.
  • Planned for thrombectomy.
  • Cardioembolism and atrial fibrillation.
  • Myocardial infarction history within 3 months.
  • Severe cerebral trauma or stroke history within 3 months.
  • Patients with systolic blood pressure ≥ 180mmHg or diastolic blood pressure ≥ 100mmHg after anti-hypertension treatment.
  • Intracranial hemorrhage or subarachnoid hemorrhage on baseline.
  • Active visceral hemorrhage.
  • Patients with intracerebral hemorrhage history.
  • Patients with diabetic retinopathy history.
  • Puncture in 1 week which can not be oppressed.
  • Major surgery or severe trauma within 2 weeks.
  • Intracranial surgery, intraspinal surgery or solid organ biopsy within 30 days.
  • Heparin treatment within 48h and increased APTT is above ULN.
  • Using of oral anticoagulant drugs and PT >15s or INR >1.7.
  • High risk of acute hemorrhage include platelet count<10^9/L.
  • Using of thrombin inhibitors or factor Xa inhibitor with abnormal results of sensitive laboratory examination.
  • Blood glucose < 2.7 mmol/L or > 22.2 mmol/L.
  • Pregnancy, lactating or menstrual women.
  • The investigator believes that the patient is not suitable for the study.

Treatment and study plan

Recombinant human urokinase

Drug

Patients receive rhPro-UK 35mg,15mg of which is given as a bolus within 3 minutes followed by dlivery of the remaining 20 mg as a constant infusion over a period of 30 minutes.

Other names: rhPro-UK

alteplase

Drug

Patients receive rt-PA in a dose of 0.9mg per kilogram of body weight(maximum,90 mg),10 percent of which was given as a blous followed by delivery of the remaining 90 percent as a constant infusion over a period of 60 minutes.

Other names: rt-PA

Primary outcomes

  1. Functional handicap

    Time frame: 90days

    Proportion of patients achieving a Modified Rankin Scale(mRS,which has a range of 0 to 6, with 0 indicating no symptoms at all and 6 indicating death) of 0 to 1 at 90 days after treatment.

Secondary outcomes

  1. Proportion of Neurological Improvement

    Time frame: 90 days

    Proportion of patients achieving a NIHSS(national institutes of health stroke scale) ≦1 or reduction of ≥4 NIHSS points at 24 hours after treatment.

  2. Scores of Neurological Improvement

    Time frame: 24 hours

    NIHSS changes from baseline at 24 hours after treatment

  3. Long-term Change from Baseline

    Time frame: 90 days

    NIHSS, mRS and Barthel Index(which assesses the ability to perform activities of daily living, on a scale that ranges from 0 to 100) changes from baseline on 90 days after treatment.

  4. Proportion of Long-term Improvement

    Time frame: 90 days

    Proportion of patients achieving a mRS of 0 to 2 and a Barthel Index of 75 to 100 at 90 days after treatment.

  5. Systemic hemorrhage

    Time frame: 90days

    Severe systemic hemorrhage

  6. Symptomatic intracerebral hemorrhage

    Time frame: 90days

    Symptomatic intracerebral hemorrhage (sICH)

  7. Death

    Time frame: 7 days and 90 days

    Death

  8. Recurrence

    Time frame: 7 days

    Recurrence of stroke

  9. Liver function

    Time frame: 7 days

    The incidence of ALT≥3ULN in liver biochemical examination

  10. Renal function

    Time frame: 7 days

    The incidence of Scr rising to 3 times or ≥ 4mg/dl more than the base value

Sponsors and collaborators

Lead sponsor

Tasly Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

A Phase III Trial to Assess the Efficacy and Safety of Recombinant Human Prourokinase in the Treatment of Acute Acute Ischaemic Stroke in 4.5 Hours After Stroke Onset

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 30, 2018
Registry last updated
Jun 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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