NCT07897955Not yet recruiting
Tenecteplase in Acute Ischemic Stroke Under Different Transfer Models
A Prospective Multicenter Observational Study of the Safety and Effectiveness of Tenecteplase (rhTNK-tPA) for Acute Ischemic Stroke Across Different Transfer Pathways
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 2000 (estimated)
- First submitted
- 21 Oct 2026
- Start date
- 1 Apr 2027
- Primary completion date
- 30 Dec 2029
- Lead sponsor
- Fujian Medical University Union Hospital
- Diseases
- Stroke
- NCT number
- NCT07897955
What you commit to
- Study type: Observational
- Planned participants: 2000
- From 1 Apr 2027 to the primary completion date, 30 Dec 2029
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Expected inability to complete follow-up.
- Considered unsuitable for participation by the investigator.
- Bacterial endocarditis or pericarditis.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Gansu Provincial Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Lanzhou | China | Unknown status |
| Liaocheng People's Hospital Coordinator of this site? Confirm its status | Liaocheng | China | Unknown status |
| Mudanjiang Forestry Central Hospital of Heilongjiang Coordinator of this site? Confirm its status | Mudanjiang | China | Unknown status |
| Shanghai Fourth People's Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Zhangzhou Municipal Hospital of Fujian Province Coordinator of this site? Confirm its status | Zhangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.