Acute Ischemic StrokeNCT07094763
Efficacy and Safety of Tenecteplase Intravenous Thrombolysis in Acute Posterior Circulation Ischemic Stroke Within 4.5-24 Hours After Onset
A study testing TNK plus standard medical treatment and standard medical management in people with Acute Ischemic Stroke, run by The First Affiliated Hospital of University of Science and Technology of China at 1 site in China.
Trial summary
This study aims to evaluate the efficacy and safety of tenecteplase (TNK) intravenous thrombolysis within the extended time window (4.5 to 24 hours) in patients with acute posterior circulation ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- TNK plus standard medical treatment and standard medical management
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- 1 siteChina
- Study dates
- 5 Nov 2025to 30 Dec 2027
- Phase
- Interventional
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Meeting at least one of the following criteria: acute posterior circulation ischemic stroke confirmed by MRI; symptomatic stenosis or occlusion of a posterior circulation large vessel on vascular imaging (CTA/MRA/DSA); perfusion imaging demonstrating clinically relevant hypoperfusion in the posterior circulation territory.
- Onset time between 4.5-24 hours (for wake-up stroke or unwitnessed stroke, onset time is defined as the midpoint between last known well and symptom detection).
- NIHSS score>3.
- PC-ASPECTS ≥7 (if discrepancy exists between DWI and CT findings, CT assessment takes precedence).
- Pre-stroke mRS ≤1.
- Signed informed consent by the patient or legally authorized representative.
Who cannot join
- Contraindication to tenecteplase or its components.
- Planing to receive endovascular therapy with thrombectomy, angioplasty or stenting whin 3 months.
- Acute anterior circulation infarction confirmed by MRI, anterior circulation large vessel occlusion on vascular imaging (CTA/MRA/DSA), or anterior circulation hypoperfusion on perfusion imaging.
- History of intracranial hemorrhage.
- Stroke, myocardial infarction, severe traumatic brain injury, or intracranial/spinal surgery within the preceding 3 months.
- Intracranial tumor, arteriovenous malformation (AVM), or giant aneurysm.
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- Active internal bleeding, major surgery, trauma, gastrointestinal/urinary tract bleeding within 3 weeks.
- Non-compressible arterial puncture within 1 week.
- Suspected aortic dissection.
- Clinically significant bleeding or coagulopathy, including: Warfarin use with INR >1.7 or PT >15 s; Low-molecular-weight heparin within 24 hours; Direct oral anticoagulants within 48 hours; Laboratory abnormalities (e.g., APTT >40 s).
- Platelet dysfunction or platelet count <100×10⁹/L.
- Uncontrolled hypertension (systolic BP >180 mmHg or diastolic BP >110 mmHg unresponsive to antihypertensive therapy).
- Uncontrolled hypoglycemia/hyperglycemia (<50 mg/dL [2.8 mmol/L] or >400 mg/dL [22.2 mmol/L]).
- Pregnancy or lactation.
- A life expectancy of less than three months.
- Participation in other clinical trials within 3 months or ongoing trial enrollment.
- Inability to follow up (e.g., no fixed residence, overseas patients).
- Patient deemed unsuitable for the trial by site investigator.
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 the University of Science and Technology of China
Hefei
Wei Hu MD,PhD, +86055162284313, andinghu@ustc.edu.cn
andinghu@ustc.edu.cn
About this study
Official title: Efficacy and Safety of Tenecteplase Intravenous Thrombolysis in Acute Posterior Circulation Ischemic Stroke Within 4.5-24 Hours After Onset: A Multicenter, Prospective, Randomized, Open-Label, Blinded Endpoint Trial
This study aims to evaluate the efficacy and safety of tenecteplase (TNK) intravenous thrombolysis within the extended time window (4.5 to 24 hours) in patients with acute posterior circulation ischemic stroke.
Read the detailed description
This multicenter, prospective, randomized, controlled trial assesses the efficacy and safety of intravenous tenecteplase for acute posterior-circulation ischemic stroke treated 4.5-24 hours after onset. Participants with imaging-confirmed stroke will be randomly assigned 1:1 to receive either tenecteplase or standard medical therapy. Eligible patients must present within 4.5-24 hours from symptom onset, defined as the midpoint between last known normal and first observed neurological deficit. All participants will undergo telephone follow-up at 3 months and 1 year, with the modified Rankin Scale as the primary outcome measure.
- Conditions
- Acute Ischemic Stroke
- Being tested
- TNK plus standard medical treatment, standard medical management
- Keywords
- TNK Intravenous Thrombolysis, Acute ischemic stroke, posterior circulation, Beyond optimal time window
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNK plus standard medical treatmentDrug
Patients in the TNK treatment group will receive TNK intravenous thrombolysis and the usual dosage for TNK intravenous thrombolysis is 0.25mg/Kg, with a maximum of 25mg.
standard medical managementDrug
standard medical management
| Study group | Role | What they receive |
|---|---|---|
| standard medical management | Active comparator | standard medical management Receives: Drug: standard medical management |
| TNK plus standard medical treatment | Experimental | Patients in the TNK treatment group will receive TNK intravenous thrombolysis and the usual dosage for TNK intravenous thrombolysis is 0.25mg/Kg, with a maximum of 25mg. Receives: Drug: TNK plus standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with modified Rankin Scale (mRS) score 0-1 at 90 ±14 days;
Measured: 90 ±14 days
Secondary outcomes (11)
Proportion of patients with mRS score 0-2 at 90 ±14 days;
Measured: 90 ±14 days
Proportion of patients with mRS score 0-3 at 90 ±14 days;
Measured: 90 ±14 days
Ordinal distribution of mRS score at 90 ±14 days;
Measured: 90 ±14 days
Change in NIHSS score at 24-36 hours post-treatment
Measured: 24 hours post-treatment
5)Change in NIHSS score at 5-7 days post-treatment;
Measured: 5-7 days post-treatment
EQ-5D-5L questionnaire score at 90 ±14 days;
Measured: 90 ±14 days
Barthel Index score at 90 ±14 days;
Measured: 90 ±14 days
1)Symptomatic intracranial hemorrhage within 36 hours (Heidelberg criteria)
Measured: 24-36 hours after treatment
Any intracranial hemorrhage within 36 hours (Heidelberg criteria)
Measured: 24-36 hours after treatment
Mortality rate at 90 ±14 days
Measured: 90 ±14 days
Overall incidence of serious adverse events
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 posted30 Jul 2025
- Study start5 Nov 2025
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Dec 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 406 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of University of Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Hu, The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094763
- Sponsor's protocol ID
- Attention-Extend IV
- Status last verified
- Jul 2025
- First submitted
- 23 Jul 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tenecteplase Intravenous Thrombolysis in Acute Posterior Circulation Ischemic Stroke Within 4.5-24 Hours After Onset: A Multicenter, Prospective, Randomized, Open-Label, Blinded Endpoint Trial
- ClinicalTrials.gov ID
- NCT07094763
- Acronym / sponsor ID
- Attention-Extend IV
- Conditions
- Acute Ischemic Stroke
- Keywords
- TNK Intravenous Thrombolysis, Acute ischemic stroke, posterior circulation, Beyond optimal time window
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 406 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of University of Science and Technology of ChinaUniversity, hospital or other
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 30 Jul 2025 (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 study aims to evaluate the efficacy and safety of tenecteplase (TNK) intravenous thrombolysis within the extended time window (4.5 to 24 hours) in patients with acute posterior circulation ischemic stroke.
Detailed description
This multicenter, prospective, randomized, controlled trial assesses the efficacy and safety of intravenous tenecteplase for acute posterior-circulation ischemic stroke treated 4.5-24 hours after onset. Participants with imaging-confirmed stroke will be randomly assigned 1:1 to receive either tenecteplase or standard medical therapy. Eligible patients must present within 4.5-24 hours from symptom onset, defined as the midpoint between last known normal and first observed neurological deficit. All participants will undergo telephone follow-up at 3 months and 1 year, with the modified Rankin Scale as the primary outcome measure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard medical management | Active comparator | Drug: standard medical managementstandard medical management |
| TNK plus standard medical treatment | Experimental | Drug: TNK plus standard medical treatmentPatients in the TNK treatment group will receive TNK intravenous thrombolysis and the usual dosage for TNK intravenous thrombolysis is 0.25mg/Kg, with a maximum of 25mg. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years.
- Meeting at least one of the following criteria: acute posterior circulation ischemic stroke confirmed by MRI; symptomatic stenosis or occlusion of a posterior circulation large vessel on vascular imaging (CTA/MRA/DSA); perfusion imaging demonstrating clinically relevant hypoperfusion in the posterior circulation territory.
- Onset time between 4.5-24 hours (for wake-up stroke or unwitnessed stroke, onset time is defined as the midpoint between last known well and symptom detection).
- NIHSS score>3.
- PC-ASPECTS ≥7 (if discrepancy exists between DWI and CT findings, CT assessment takes precedence).
Key exclusion criteria (18 listed)
- Contraindication to tenecteplase or its components.
- Planing to receive endovascular therapy with thrombectomy, angioplasty or stenting whin 3 months.
- Acute anterior circulation infarction confirmed by MRI, anterior circulation large vessel occlusion on vascular imaging (CTA/MRA/DSA), or anterior circulation hypoperfusion on perfusion imaging.
- History of intracranial hemorrhage.
- Stroke, myocardial infarction, severe traumatic brain injury, or intracranial/spinal surgery within the preceding 3 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 |
|---|---|---|
| TNK plus standard medical treatmentPatients in the TNK treatment group will receive TNK intravenous thrombolysis and the usual dosage for TNK intravenous thrombolysis is 0.25mg/Kg, with a maximum of 25mg. | Drug | TNK plus standard medical treatment |
| standard medical managementstandard medical management | Drug | standard medical management |
Primary outcome
Proportion of patients with modified Rankin Scale (mRS) score 0-1 at 90 ±14 days;
Time frame: 90 ±14 days
11 secondary outcomes
Proportion of patients with mRS score 0-2 at 90 ±14 days;
Time frame: 90 ±14 days
Proportion of patients with mRS score 0-3 at 90 ±14 days;
Time frame: 90 ±14 days
Ordinal distribution of mRS score at 90 ±14 days;
Time frame: 90 ±14 days
Change in NIHSS score at 24-36 hours post-treatment
Time frame: 24 hours post-treatment
5)Change in NIHSS score at 5-7 days post-treatment;
Time frame: 5-7 days post-treatment
EQ-5D-5L questionnaire score at 90 ±14 days;
Time frame: 90 ±14 days
Barthel Index score at 90 ±14 days;
Time frame: 90 ±14 days
1)Symptomatic intracranial hemorrhage within 36 hours (Heidelberg criteria)
Time frame: 24-36 hours after treatment
Any intracranial hemorrhage within 36 hours (Heidelberg criteria)
Time frame: 24-36 hours after treatment
Mortality rate at 90 ±14 days
Time frame: 90 ±14 days
Overall incidence of serious adverse events
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 8 Jun 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TNK plus standard medical treatment and standard medical management in people with Acute Ischemic Stroke, run by The First Affiliated Hospital of University of Science and Technology of China 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 7 inclusion and 18 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 8 Jun 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 Wei Hu MD,PhD (+86055162284313, andinghu@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with modified Rankin Scale (mRS) score 0-1 at 90 ±14 days; (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 8 Jun 2026.