Comparing Urokinase and Alteplase for Treating Acute Ischemic Stroke
Treatment of Acute Ischemic StroKe With Intravenous UroKinase Real-world Research: a Multicenter, Prospective Study (TASK-UK)
This study is testing if a cheaper medication called urokinase works as well and is as safe as the more expensive drug alteplase for treating people with acute ischemic stroke.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Zhengzhou University Academic / other |
| Locations | 16 sites (Lanzhou, Gansu and 15 other locations) |
| Trial ID | NCT06194968 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the safety and effectiveness of intravenous urokinase versus intravenous alteplase in treating acute ischemic stroke (AIS) patients within 6 hours of symptom onset. It will be a multicenter, real-world observational study that analyzes the outcomes of patients treated with both medications. The research will focus on evaluating the effectiveness, safety, and economic implications of using urokinase, which is significantly cheaper than alteplase. By exploring different dosages of urokinase and relevant risk factors, the study seeks to provide valuable data for future assessments of urokinase's clinical effects.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been clinically diagnosed with acute ischemic stroke and are eligible for treatment with intravenous urokinase or alteplase.
Not a fit: Patients with contraindications for thrombolysis or those who do not meet the inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more affordable and effective treatment option for patients suffering from acute ischemic stroke.
How similar studies have performed: While existing evidence on urokinase's effectiveness is mixed, this study aims to provide new insights and data that could support its use in treating acute ischemic stroke.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:Age: ≥18 years. Clinical diagnosis of acute ischemic stroke, defined as an event characterized by the sudden onset of an acute focal neurologic deficit, unilateral motor dysfunction or impairment of language presumed to be due to cerebral ischemia after, with imaging evidence of a causative lesion or symptoms/signs persisting for over 24 hours. CT scan should exclude hemorrhage and non-vascular etiology. 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. \- Exclusion Criteria:Contraindications for thrombolysis (refer to the 2018 Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke, intravenous thrombolysis contraindications). 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. \-
Where this trial is running
Lanzhou, Gansu and 15 other locations
- The First People's Hospital of Lanzhou City — Lanzhou, Gansu, China (Not_yet_recruiting)
- Affiliated Hospital of Guangdong Medical University — Zhanjiang, Guangdong, China (Not_yet_recruiting)
- Beiliu People's Hospital — Beiliu, Guangxi, China (Not_yet_recruiting)
- Guidong People's Hospital of Guangxi zhuang Autonomous Region — Guidong, Guangxi, China (Not_yet_recruiting)
- Tengxian People's Hospital — Wuzhou, Guangxi, China (Not_yet_recruiting)
- Red Cross Hospital of Yulin City — Yulin, Guangxi, China (Not_yet_recruiting)
- The First People's Hospital of Yulin — Yulin, Guangxi, China (Not_yet_recruiting)
- Sanya People's Hospital — Sanya, Hainan, China (Not_yet_recruiting)
- The First Affiliated Hospital of Jiamusi University — Jiamusi, Heilongjiang, China (Not_yet_recruiting)
- The People's Hospital of Anyang City — Anyang, Henan, China (Not_yet_recruiting)
- Kaifeng Central Hospital — Kaifeng, Henan, China (Not_yet_recruiting)
- The Second People's Hospital of Mengjin District — Luoyang, Henan, China (Not_yet_recruiting)
- Pingdingshan The Second People's Hospital — Pingdingshan, Henan, China (Not_yet_recruiting)
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
- Huiji District People's Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
- Affiliated Hospital of Inner Mongolia Minzu University — Tongliao, Inner Mongolia, China (Not_yet_recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.