Treatment of Acute Ischemic StroKe With Intravenous UroKinase Real-world Research: a Multicenter, Prospective Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-30

Study Completion Date

2026-12-01

Brief Summary

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The purpose of this study is to to compare the safety and effectiveness of IV urokinase with IV alteplase in the treatment of AIS in patients up to 6 hours from symptom onset.

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Detailed Description

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Recombinant tissue plasminogen activator (alteplase) is currently the recommended treatment of AIS in patients within 0 to 4.5 hours from symptom onset. The cost of a single treatment with this drug is around 5000 RMB (about 700 USD). In contrast, the cost of a single dose of urokinase is around 300 RMB (about 40 USD), making it much more affordable. Currently, existing evidence regarding the effectiveness and safety of urokinase is mixed. Some studies propose that urokinase thrombolysis, compared with alteplase thrombolysis, improves perfusion without increasing the incidence of adverse reactions and mortality. In some cases, using urokinase for thrombolysis even lowers the risk of systemic bleeding, comparing to alteplase. Other studies suggest that the effectiveness and safety of urokinase intreating AIS patients is infeiror comparing to alteplase . In this study, we plan to conduct a nationwide multicenter real-world study on urokinase intravenous thrombolysis with alteplase as an active control. We will observe and analyze AIS patients treated with urokinase and alteplase and compare the effectiveness, safety and economic effects. We will explore different urokinase dosage efficacy indicators and analyze relevant risk factors. This will provide data for future systematic evaluations of the clinical effects of urokinase thrombolysis which may help lower the medical costs in treating AIS while ensuring the effectiveness.

Conditions

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Acute Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Experimental: Urokinase

Urokinase

Intervention Type DRUG

administered intravenously

Active Comparator: Alteplase

Alteplase

Intervention Type DRUG

administered intravenously

Interventions

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Urokinase

administered intravenously

Intervention Type DRUG

Alteplase

administered intravenously

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

First-time occurrence or a history of stroke without significant neurological deficits (baseline mRS score ≤ 1).

Eligible for treatment with intravenous administration of urokinase or alteplase as assessed by the investigators.

Patient is willing to participate voluntarily and to sign a written patient informed consent. Informed consent will be obtained from each patient or the subject's legally authorized representative or relatives, or deferred where applicable.

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Exclusion Criteria

Female of childbearing potential who is known to be pregnant and/or lactating or who has a positive pregnancy test on admission.

Known history of drug (narcotics, controlled substances) abuse or addiction in the past year.

Has an expected survival of less than 90 days due to concurrent malignant tumors or severe systemic diseases Incapable to comply with the protocol due to mental illness or cognitive disorder.

Paticipants of any interventional drug or device clinical trials within 3 months prior to screening.

Unsuitable for this study in the opinion of the investigators.

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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Bo Song

chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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