Using Tenecteplase for treating acute ischemic stroke in China
Tenecteplase Thrombolytic Therapy for Acute Ischemic Stroke in China a Real-world, Multicenter, Retrospective, Controlled Study
Huashan Hospital · NCT06078995
This study is testing if a new quick-acting stroke treatment called tenecteplase is safe and effective for people who have had an acute ischemic stroke within 4.5 hours of their symptoms starting.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Sex | All |
| Sponsor | Huashan Hospital (other) |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06078995 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness and safety of recombinant human tenecteplase tissue-type plasminogen activator (rhTNK-tPA) in patients with acute ischemic stroke who present within 4.5 hours of symptom onset. Unlike traditional treatments that require a lengthy infusion, rhTNK-tPA can be administered as a single bolus, potentially improving treatment efficiency. The study is observational and retrospective, focusing on real-world outcomes from multiple centers across China. It aims to provide insights into the practical application of rhTNK-tPA compared to standard treatments.
Who should consider this trial
Good fit: Ideal candidates include acute ischemic stroke patients eligible for thrombolysis who present within 4.5 hours of symptom onset.
Not a fit: Patients with significant missing data or those who do not meet the eligibility criteria for thrombolysis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more efficient and effective treatment option for patients experiencing acute ischemic stroke.
How similar studies have performed: Previous randomized controlled trials have shown the non-inferiority of rhTNK-tPA compared to traditional treatments, but this study aims to explore its effectiveness in real-world settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * all acute ischaemic stroke patients who met eligibility for thrombolysis with intravenous alteplase or TNK and presenting within 4·5 hours of symptom onset. Exclusion Criteria: * variables with a missing rate \> 40%
Where this trial is running
Shanghai
- Xin Chen — Shanghai, China (RECRUITING)
Study contacts
- Principal investigator: Qiang Dong — Huashan Hospital
- Study coordinator: Qiang Dong, M.D. Ph.D.
- Email: qiang_dong163@163.com
- Phone: 86-021-52887142
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.
Conditions: Ischemic Stroke, intravenous thrombolysis, Tenecteplase