Tenecteplase in Acute Ischemic Stroke Under Different Transfer Models
Key facts
- Where
- Fuzhou, Lanzhou, Liaocheng, Mudanjiang, Shanghai, and Zhangzhou, ChinaSee the 6 sites
Where in China
- Fujian Medical University Union HospitalFuzhou, ChinaNo longer taking part
- Gansu Provincial Hospital of Traditional Chinese MedicineLanzhou, ChinaNo longer taking part
- Liaocheng People's HospitalLiaocheng, ChinaNo longer taking part
- Mudanjiang Forestry Central Hospital of HeilongjiangMudanjiang, ChinaNo longer taking part
- Shanghai Fourth People's HospitalShanghai, ChinaNo longer taking part
- Zhangzhou Municipal Hospital of Fujian ProvinceZhangzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fujian Medical University Union Hospital
- Trial code
- NCT07897955
- Record updated
- 27 October 2026
- Original description
This prospective, multicenter, observational cohort study aims to evaluate the safety and effectiveness of intravenous tenecteplase (rhTNK-tPA) in patients with acute ischemic stroke managed under different transfer models. Treatment decisions are made by the treating physicians as part of routine clinical care and are not assigned by the study protocol. Clinical information, imaging findings, laboratory results, treatment data, and functional outcomes will be collected. Participants will be followed for 90 days. The primary effectiveness outcome is the modified Rankin Scale score at 90 days. Safety outcomes include symptomatic intracranial hemorrhage within 48 hours and all-cause mortality at 90 days.Read full original descriptionShow less
A Prospective Multicenter Observational Study of the Safety and Effectiveness of Tenecteplase (rhTNK-tPA) for Acute Ischemic Stroke Across Different Transfer Pathways
This prospective, multicenter, observational cohort study aims to evaluate the safety and effectiveness of intravenous tenecteplase (rhTNK-tPA) in patients with acute ischemic stroke managed under different transfer models. Treatment decisions are made by the treating physicians as part of routine clinical care and are not assigned by the study protocol. Clinical information, imaging findings, laboratory results, treatment data, and functional outcomes will be collected. Participants will be followed for 90 days. The primary effectiveness outcome is the modified Rankin Scale score at 90 days. Safety outcomes include symptomatic intracranial hemorrhage within 48 hours and all-cause mortality at 90 days.
Inclusion: Age 18 years or older; Acute ischemic stroke diagnosed based on clinical symptoms and signs; Acute ischemic stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI); Receipt of intravenous thrombolysis with tenecteplase; Written informed consent provided by the participant or the participant's legally authorized representative.
Exclusion: Current significant bleeding disorder or a significant bleeding disorder within the previous 6 months; Prolonged cardiopulmonary resuscitation lasting more than 2 minutes, childbirth, or puncture of a noncompressible blood vessel, such as a subclavian or internal jugular vein puncture, within the previous 2 weeks; Treatment with an oral anticoagulant and an international normalized ratio greater than 1.3; Severe trauma or major surgery within the previous 3 months; Intracranial hemorrhage confirmed by brain CT or MRI; Active internal bleeding; Known history of intracranial hemorrhage or suspected intracranial hemorrhage; Known bleeding diathesis; Significant, recent, severe, or potentially dangerous bleeding; History of a central nervous system lesion or trauma, including intracranial tumor, arteriovenous malformation, aneurysm, or intracranial or spinal surgery; Aneurysmal subarachnoid hemorrhage or suspected subarachnoid hemorrhage; Tumor associated with an increased risk of bleeding; Acute pancreatitis, active gastrointestinal ulcer, aneurysm, or arteriovenous malformation; Severe liver disease, including hepatic failure, cirrhosis, portal hypertension with esophageal varices, or active hepatitis; Expected inability to complete follow-up; Considered unsuitable for participation by the investigator; Bacterial endocarditis or pericarditis.