Acute Ischemic StrokeNCT07475936
Intravenous Tenecteplase in Very Old Patients With Acute Ischemic Stroke
An observational study of Acute Ischemic Stroke and Tenecteplase, run by First Affiliated Hospital of Guangxi Medical University at 1 site in China.
Trial summary
The benefit of intravenous tenecteplase in very old patients with acute ischemic stroke (AIS) remain uncertain. This real-world study aims to evaluate the effectiveness and safety of intravenous tenecteplase in AIS patients aged 80 years or older within 4.5 hours of symptom onset. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Tenecteplase
- What is being tested?
- Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg) and Standard medical care
- Type of treatment
- Injection or infusion
- How many people
- 392 participants
- Where
- 1 siteChina
- Study dates
- 22 Mar 2026to Dec 2027
- 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 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: This study will consecutively screen patients with acute ischemic stroke (AIS) who are over 80 years of age and arrive at the hospital within 4.5 hours of symptom onset.
Who may be able to join
- Age > 80 years;
- Clinically diagnosed with acute ischemic stroke and arrived at the hospital within 4.5 hours of symptom onset;
- Informed consent signed by the patient or legally authorized representative.
Who cannot join
- Any contraindication to intravenous thrombolysis (excluding age);
- Previous treatment with other thrombolytic agents such as alteplase, urokinase, plasminogen activator, or reteplase;
- Current participation in other interventional studies;
- The investigator deems the patient unsuitable for this study or the study might pose significant risk to the patient (e.g., due to psychiatric disorders, cognitive or emotional impairments that prevent understanding or adherence to study procedures and/or follow-up).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Dong Pan, MD, PhD, 86-156 2648 3251, dongpan012@hotmail.com
About this study
Official title: A Multicenter, Prospective, Observational, Real-World Registry Study of Intravenous Tenecteplase in Very Old Patients With Acute Ischemic Stroke
The benefit of intravenous tenecteplase in very old patients with acute ischemic stroke (AIS) remain uncertain. This real-world study aims to evaluate the effectiveness and safety of intravenous tenecteplase in AIS patients aged 80 years or older within 4.5 hours of symptom onset.
Read the detailed description
The study is an investigator-initiated, multicenter, prospective, observational, real-world registry designed to evaluate the effectiveness and safety of intravenous tenecteplase in AIS patients aged 80 years or older within 4.5 hours of symptom onset. The primary outcome is excellent outcome, as defined by a score of 0 or 1 on modified Rankin Scale (mRS) at 90 days. The study is anticipated to enroll at least 392 participants, with no less than 196 participants in the tenecteplase group.
- Conditions
- Acute Ischemic Stroke, Tenecteplase
- Being tested
- Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg), Standard medical care
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)Drug
Tenecteplase is administered as a single intravenous bolus at a dose of 0.25 mg/kg, with a maximum of 25 mg.
Standard medical careOther
Standard medical treatment should adhere to clinical guidelines and usual care at site, including antiplatelet therapy, anticoagulant therapy, lipid-lowering therapy, antihypertensive drugs, etc., as determined by the local investigators.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Standard medical treatment Receives: Other: Standard medical care | |
| Tenecteplase group | Intravenous tenecteplase thrombolysis Receives: Drug: Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg); Other: Standard medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excellent outcome
The proportion of modified Rankin Scale (mRS) score of 0-1 at 90 days
Measured: 90 (±14) days
Secondary outcomes (5)
Level of disability
Ordinal shift analysis of the mRS with 5-6 merged at 90 days.
Measured: 90 (±14) days
Functional independence
The proportion of mRS score of 0-2 at 90 days.
Measured: 90 (±14) days
Early neurological improvement
The proportion of NIHSS 0-1 or ≥4 points reduction at 24 hours.
Measured: 24 (±12) hours
Change in stroke severity
The change of NIHSS score from enrollment to 7 days or at discharge (whichever comes first).
Measured: 7 (±1) days or at discharge
Quality of life measured by EQ-5D-5L
EQ-5D-5L scale score at 90 days.
Measured: 90 (±14) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start22 Mar 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (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
- 392 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuan Wu, MD, PhD, Principal investigator, First Affiliated Hospital of Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475936
- Sponsor's protocol ID
- 2025-K0668
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data supporting the findings of the study are available on reasonable request after approval of a proposal from the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Observational, Real-World Registry Study of Intravenous Tenecteplase in Very Old Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT07475936
- Acronym / sponsor ID
- 2025-K0668
- Conditions
- Acute Ischemic Stroke, Tenecteplase
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 392 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 22 Mar 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Mar 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.
The benefit of intravenous tenecteplase in very old patients with acute ischemic stroke (AIS) remain uncertain. This real-world study aims to evaluate the effectiveness and safety of intravenous tenecteplase in AIS patients aged 80 years or older within 4.5 hours of symptom onset.
Detailed description
The study is an investigator-initiated, multicenter, prospective, observational, real-world registry designed to evaluate the effectiveness and safety of intravenous tenecteplase in AIS patients aged 80 years or older within 4.5 hours of symptom onset. The primary outcome is excellent outcome, as defined by a score of 0 or 1 on modified Rankin Scale (mRS) at 90 days. The study is anticipated to enroll at least 392 participants, with no less than 196 participants in the tenecteplase group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: Standard medical careStandard medical treatment |
| Tenecteplase group | – | Drug: Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg), Other: Standard medical careIntravenous tenecteplase thrombolysis |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- This study will consecutively screen patients with acute ischemic stroke (AIS) who are over 80 years of age and arrive at the hospital within 4.5 hours of symptom onset.
Key inclusion criteria (3 listed)
- Age > 80 years;
- Clinically diagnosed with acute ischemic stroke and arrived at the hospital within 4.5 hours of symptom onset;
- Informed consent signed by the patient or legally authorized representative.
Key exclusion criteria (4 listed)
- Any contraindication to intravenous thrombolysis (excluding age);
- Previous treatment with other thrombolytic agents such as alteplase, urokinase, plasminogen activator, or reteplase;
- Current participation in other interventional studies;
- The investigator deems the patient unsuitable for this study or the study might pose significant risk to the patient (e.g., due to psychiatric disorders, cognitive or emotional impairments that prevent understanding or adherence to study procedures and/or follow-up).
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 |
|---|---|---|
| Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)Tenecteplase is administered as a single intravenous bolus at a dose of 0.25 mg/kg, with a maximum of 25 mg. | Drug | Tenecteplase group |
| Standard medical careStandard medical treatment should adhere to clinical guidelines and usual care at site, including antiplatelet therapy, anticoagulant therapy, lipid-lowering therapy, antihypertensive drugs, etc., as determined by the local investigators. | Other | Control group, Tenecteplase group |
Primary outcome
Excellent outcome
Time frame: 90 (±14) days
The proportion of modified Rankin Scale (mRS) score of 0-1 at 90 days
5 secondary outcomes
Level of disability
Time frame: 90 (±14) days
Functional independence
Time frame: 90 (±14) days
Early neurological improvement
Time frame: 24 (±12) hours
Change in stroke severity
Time frame: 7 (±1) days or at discharge
Quality of life measured by EQ-5D-5L
Time frame: 90 (±14) 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 31 Aug 2026.
- Individual participant dataSharing planned: Yes. Data supporting the findings of the study are available on reasonable request after approval of a proposal from the principal investigator.
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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.
Yuan Wu, MD, PhD principal investigator
First Affiliated Hospital of Guangxi Medical University
1 site 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 and Tenecteplase, run by First Affiliated Hospital of Guangxi Medical University at 1 site 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Dong Pan, MD, PhD (86-156 2648 3251, dongpan012@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excellent outcome (time frame: 90 (±14) 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 31 Aug 2026.