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Not yet recruitingNCT07897955Updated Oct 27, 2026

Tenecteplase in Acute Ischemic Stroke Under Different Transfer Models

An observational study in Acute Ischemic Stroke, sponsored by Fujian Medical University Union Hospital. Not yet recruiting at 6 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Fujian Medical University Union Hospital · Observational

Updated Oct 27, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Acute Ischemic Stroke

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03

In context

Ischemic Stroke

2,679 studies on the registry are indexed under Ischemic Stroke; 959 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 300 across 794 observational studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Fujian Medical University Union Hospital is the lead sponsor of 107 studies on the registry; 78 are open to participants now.

Browse Fujian Medical University Union Hospital studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Target follow-up
90 Days
Patient registry
Yes

Groups and cohorts

  • 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.

    Drug: tenecteplase

Interventions

  • Drugtenecteplase

    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.

06

What researchers measure

Primary outcomes

  1. Modified Rankin Scale Score at 90 Days

    Time frame: 90 days after tenecteplase administration (±7 days)

Secondary outcomes

  1. 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.

    Time frame: 90 days after tenecteplase administration (±7 days)

  2. 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.

    Time frame: 90 days after tenecteplase administration (±7 days)

  3. 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.

    Time frame: Baseline to 7 days after tenecteplase administration (±2 days) or hospital discharge

  4. EQ-5D-5L Score at 90 Days

    Time frame: 90 days after tenecteplase administration (±7 days)

  5. Incidence of Symptomatic Intracranial Hemorrhage Within 48 Hours

    Time frame: Within 48 hours after tenecteplase administration

  6. All-Cause Mortality at 90 Days

    Time frame: Within 90 days after tenecteplase administration

  7. Incidence of Asymptomatic Intracranial Hemorrhage Within 48 Hours

    Time frame: Within 48 hours after tenecteplase administration

  8. 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.

    Time frame: From tenecteplase administration through 90 days

  9. 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.

    Time frame: From tenecteplase administration through 90 days

07

Study locations

6 sites
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2027; primary completion for Dec 2029, 32 months later.

Of 387 non-industry observational studies under Ischemic Stroke, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 167. This study's planned 32 months is below that.

Counting every sponsor, half of 432 studies reached it within 51 months; a quarter within 24 and three quarters within 115.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 21, 2026
First posted
Oct 27, 2026
StartEst.
Apr 1, 2027
Primary completionEst.
Dec 30, 2029
CompletionEst.
Dec 30, 2029
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07897955
Lead sponsor
Fujian Medical University Union Hospital
Collaborators
Zhangzhou Affiliated Hospital of Fujian Medical University
Responsible party
Sponsor
First posted
Oct 27, 2026
Start date
Apr 1, 2027 (estimated)
Primary completion
Dec 30, 2029 (estimated)
Completion
Dec 30, 2029 (estimated)
Last update
Oct 27, 2026

Study contacts

Wenhuo Chen
Contact
docterwwenhuo@126.com
0591-86218022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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