Comparing Tenecteplase and Alteplase for Treating Ischemic Stroke
Tenecteplase Versus Alteplase for Thrombolysis in Patients Within 4.5 H of Onset of Ischemic Stroke : a Multicenter, Prospective, Observational, Real-world Study（TRANSIT）
This study is testing whether tenecteplase or alteplase is better for treating people who have had an ischemic stroke within 4.5 hours of their symptoms starting.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 6000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tianjin Huanhu Hospital Academic / other |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT06621121 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the safety, efficacy, and economic benefits of two thrombolytic agents, tenecteplase and alteplase, in patients experiencing acute ischemic stroke within 4.5 hours of symptom onset. It involves a prospective, multicenter, open-label design, enrolling 6000 individuals who meet the criteria for intravenous thrombolysis. Patients will receive either tenecteplase or alteplase based on their clinical condition and preferences, with assessments conducted at multiple time points to evaluate outcomes. The study seeks to provide insights into optimizing thrombolytic therapy tailored to various patient profiles.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who exhibit neurological deficits due to ischemic stroke and can receive treatment within 4.5 hours of symptom onset.
Not a fit: Patients with absolute contraindications to thrombolysis or those who have participated in another clinical trial within the last three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify the most effective thrombolytic treatment for ischemic stroke, potentially improving patient outcomes.
How similar studies have performed: Previous studies comparing tenecteplase and alteplase have shown promising results, but this study aims to provide real-world evidence to support clinical decision-making.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- 1. Symptoms of neurological deficit caused by ischemic stroke; 2. The time from onset to treatment ≤4.5 hours; The time of onset of symptoms was defined as the time of last seen normal. 3\. Age ≥18 years old; 4. Signed informed consent by patients or their legally authorized representative. Exclusion Criteria: * 1\. Any absolute contraindication to thrombolysis in the \"Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2023\" 2.Allergy to TNK or alteplase 3.Participation in another clinical trial within the previous 3 months. 4.Other conditions deemed inappropriate for participation in this study.
Where this trial is running
Tianjin, Tianjin Municipality
- Tianjin Huanhu Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Principal investigator: Jialing Wu, MD,PhD — Tianjin Huanhu Hospital
- Study coordinator: Shoufeng Liu, MD
- Email: shoufengliu2010@163.com
- Phone: 400-802-7885
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.