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

NCT03541668 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 674

Last updated 2020-06-22

No results posted yet for this study

Summary

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.

Conditions

  • Acute Ischaemic Stroke

Interventions

DRUG

Recombinant human urokinase

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.

DRUG

Alteplase

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.

Sponsors & Collaborators

  • Tasly Biopharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-18
Primary Completion
2020-04-14
Completion
2020-05-24

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03541668 on ClinicalTrials.gov