Acute Ischemic StrokeNCT07897955
Tenecteplase in Acute Ischemic Stroke Under Different Transfer Models
An observational study of Acute Ischemic Stroke, run by Fujian Medical University Union Hospital at 6 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- tenecteplase
- Type of treatment
- Injection or infusion
- How many people
- 2,000 participants
- Where
- 6 sitesChina
- Study dates
- 1 Apr 2027to 30 Dec 2029
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult patients with acute ischemic stroke who receive intravenous tenecteplase as part of routine clinical care at participating stroke centers in China. Eligible participants will be enrolled prospectively and consecutively after the treatment decision has been made independently by the treating physician. The study protocol does not assign or recommend any treatment or transfer pathway. Clinical, imaging, laboratory, treatment, safety, and functional outcome data will be collected, and participants will be followed for 90 days after tenecteplase administration.
Who may be able to join
- 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.
Who cannot join
- Intracranial hemorrhage confirmed by brain CT or MRI.
- Expected inability to complete follow-up.
- Considered unsuitable for participation by the investigator.
- Active internal bleeding.
- Current significant bleeding disorder or a significant bleeding disorder within the previous 6 months.
- Known history of intracranial hemorrhage or suspected intracranial hemorrhage.
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- 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.
- Bacterial endocarditis or pericarditis.
- 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.
- Acute pancreatitis, active gastrointestinal ulcer, aneurysm, or arteriovenous malformation.
- Treatment with an oral anticoagulant and an international normalized ratio greater than 1.3.
- Severe liver disease, including hepatic failure, cirrhosis, portal hypertension with esophageal varices, or active hepatitis.
- Severe trauma or major surgery within the previous 3 months.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Wenhuo Chen, 0591-86218022, doctorwwenhuo@126.com
Gansu Provincial Hospital of Traditional Chinese Medicine
Lanzhou, Gansu, 730050
Ya Shao, 0931-2687109, shaoya20042001@126.com
Liaocheng People's Hospital
Liaocheng, Shandong, 252000
Meng Zhang, 0635-8276133, 13406399660@126.com
Mudanjiang Forestry Central Hospital of Heilongjiang
Mudanjiang, Heilongjiang, 157000
Zhentao Li, 0453-6513186, 277634746@qq.com
Shanghai Fourth People's Hospital
Shanghai, Shanghai Municipality, 200434
Yibin Fang, 021-55603999, fangyibin@vip.163.com
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, 363000
Tingyu Yi, 0596-2082384, siyuyufen@163.com
About this study
Official title: 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- tenecteplase
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tenecteplaseDrug
Intravenous tenecteplase administered as part of routine clinical care. The decision to administer tenecteplase, including the dose and treatment timing, is made independently by the treating physician and is not assigned by the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Patients Treated With Tenecteplase | Patients with acute ischemic stroke who receive intravenous tenecteplase as part of routine clinical care and are followed for 90 days. Treatment and transfer decisions are made by the treating physicians and are not assigned by the study protocol. Receives: Drug: tenecteplase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale Score at 90 Days
Measured: 90 days after tenecteplase administration (±7 days)
Secondary outcomes (9)
Proportion of Participants With an mRS Score of 0-2 at 90 Days
The percentage of participants with a modified Rankin Scale (mRS) score of 0-2 at 90 days. The mRS ranges from 0 to 6, with lower scores indicating better functional outcomes. A score of 0-2 indicates functional independence.
Measured: 90 days after tenecteplase administration (±7 days)
Proportion of Participants With an mRS Score of 0-1 at 90 Days
The percentage of participants with a modified Rankin Scale (mRS) score of 0-1 at 90 days. A score of 0 indicates no symptoms, and a score of 1 indicates no significant disability despite symptoms.
Measured: 90 days after tenecteplase administration (±7 days)
Change in NIHSS Score From Baseline to Day 7 or Discharge
Change in the National Institutes of Health Stroke Scale (NIHSS) score from baseline to day 7 or hospital discharge. The NIHSS ranges from 0 to 42, with higher scores indicating greater neurological impairment. A reduction in the score indicates neurological improvement.
Measured: Baseline to 7 days after tenecteplase administration (±2 days) or hospital discharge
EQ-5D-5L Score at 90 Days
Measured: 90 days after tenecteplase administration (±7 days)
Incidence of Symptomatic Intracranial Hemorrhage Within 48 Hours
Measured: Within 48 hours after tenecteplase administration
All-Cause Mortality at 90 Days
Measured: Within 90 days after tenecteplase administration
Incidence of Asymptomatic Intracranial Hemorrhage Within 48 Hours
Measured: Within 48 hours after tenecteplase administration
Incidence of Non-Intracranial Bleeding Complications
The percentage of participants who experience non-intracranial bleeding complications, including gastrointestinal bleeding, urinary tract bleeding, oral or nasal mucosal bleeding, and subcutaneous hematoma.
Measured: From tenecteplase administration through 90 days
Incidence of Non-Bleeding Serious Adverse Events
The percentage of participants who experience non-bleeding serious adverse events, including cerebral herniation, pneumonia, respiratory failure, circulatory failure, stress ulcer, secondary epilepsy, urinary tract infection, sepsis, renal failure, acute coronary syndrome, venous thrombosis, or psychiatric symptoms.
Measured: From tenecteplase administration through 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Apr 2027 (estimated)
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhangzhou Affiliated Hospital of Fujian Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897955
- Sponsor's protocol ID
- FJ Union Hospital
- Status last verified
- Sep 2026
- First submitted
- 21 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Observational Study of the Safety and Effectiveness of Tenecteplase (rhTNK-tPA) for Acute Ischemic Stroke Across Different Transfer Pathways
- ClinicalTrials.gov ID
- NCT07897955
- Acronym / sponsor ID
- FJ Union Hospital
- Conditions
- Acute Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Collaborators
- Zhangzhou Affiliated Hospital of Fujian Medical University
- Study start
- 1 Apr 2027 (estimated)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Treated With Tenecteplase | – | Drug: tenecteplasePatients with acute ischemic stroke who receive intravenous tenecteplase as part of routine clinical care and are followed for 90 days. Treatment and transfer decisions are made by the treating physicians and are not assigned by the study protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients with acute ischemic stroke who receive intravenous tenecteplase as part of routine clinical care at participating stroke centers in China. Eligible participants will be enrolled prospectively and consecutively after the treatment decision has been made independently by the treating physician. The study protocol does not assign or recommend any treatment or transfer pathway. Clinical, imaging, laboratory, treatment, safety, and functional outcome data will be collected, and participants will be followed for 90 days after tenecteplase administration.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- Intracranial hemorrhage confirmed by brain CT or MRI.
- Expected inability to complete follow-up.
- Considered unsuitable for participation by the investigator.
- Active internal bleeding.
- Current significant bleeding disorder or a significant bleeding disorder within the previous 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tenecteplaseIntravenous tenecteplase administered as part of routine clinical care. The decision to administer tenecteplase, including the dose and treatment timing, is made independently by the treating physician and is not assigned by the study protocol. | Drug | Patients Treated With Tenecteplase |
Primary outcome
Modified Rankin Scale Score at 90 Days
Time frame: 90 days after tenecteplase administration (±7 days)
9 secondary outcomes
Proportion of Participants With an mRS Score of 0-2 at 90 Days
Time frame: 90 days after tenecteplase administration (±7 days)
Proportion of Participants With an mRS Score of 0-1 at 90 Days
Time frame: 90 days after tenecteplase administration (±7 days)
Change in NIHSS Score From Baseline to Day 7 or Discharge
Time frame: Baseline to 7 days after tenecteplase administration (±2 days) or hospital discharge
EQ-5D-5L Score at 90 Days
Time frame: 90 days after tenecteplase administration (±7 days)
Incidence of Symptomatic Intracranial Hemorrhage Within 48 Hours
Time frame: Within 48 hours after tenecteplase administration
All-Cause Mortality at 90 Days
Time frame: Within 90 days after tenecteplase administration
Incidence of Asymptomatic Intracranial Hemorrhage Within 48 Hours
Time frame: Within 48 hours after tenecteplase administration
Incidence of Non-Intracranial Bleeding Complications
Time frame: From tenecteplase administration through 90 days
Incidence of Non-Bleeding Serious Adverse Events
Time frame: From tenecteplase administration through 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by Fujian Medical University Union Hospital at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenhuo Chen (0591-86218022, docterwwenhuo@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale Score at 90 Days (time frame: 90 days after tenecteplase administration (±7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.