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Acute Ischemic StrokePhase 3TNK LATENCT07168278

Tenecteplase vs Medical Management in 4.5-24h LVO no Access to EVT

A Phase 3 study testing TNK and Standard medical treatment in people with Acute Ischemic Stroke and Large Vessel Occlusion, run by The First Affiliated Hospital of University of Science and Technology of China at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to learn if tenectplase works to acute ischemic stroke (AIS) with onset 4.5-9 hours. It will also learn about the safety of tenectplase in AIS with onset 4.5-9 hours. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TNK and Standard medical treatment
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
794 participants
Where
1 siteChina
Study dates
1 Nov 2025to 31 May 2028
Phase
Phase 3
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

Who may be able to join

  • Age 18 years or greater
  • Acute ischemic stroke presenting in the 4.5 to 24 hour window from last seen well (including wake-up stroke and no witness stroke).
  • Prestroke mRS 0-2
  • NIHSS 6 to 25
  • Aspect ≥ 7
  • ICA terminus, M1, dominant M2 occlusion on CTA or MRA
  • Clinical-imaging mismatch assessed by investigator
  • Patients with no access to EVT at the time of randomization

Who cannot join

  • Current or past history of significant bleeding over the past 6 months;
  • History of intracranial hemorrhage (including possible subarachnoid hemorrhage or subarachnoid hemorrhage due to an aneurysm) or evidence or suspected intracranial hemorrhage;
  • Known bleeding tendency;
  • Recent severe or dangerous bleeding, or active ulcerative gastrointestinal disease;
  • History of central nervous system injury (e.g., intracranial tumor, aneurysm, or arteriovenous malformation, intracranial or spinal surgery), or recent head injury；
  • Tumors that increase risk of bleeding;
Show all 24Show fewer
  • Severe liver dysfunction, including liver failure, cirrhosis, portal hypertension (esophageal varices), and active hepatitis;
  • Know arterial / venous malformation or aneurysm;
  • Bacterial endocarditis, pericarditis, or acute pancreatitis;
  • Patients receiving effective anticoagulant therapy (vitamin K antagonists with INR > 1.3, or other oral anticoagulants exceeding the upper limit of the corresponding standard range);
  • Heparin use within the past 48 hours and prothrombin time exceeding the upper limit of the standard range;
  • Over the past 3 months, undergone major surgery, organ biopsy, or suffered a serious injury;
  • Over the past 2 weeks, receiving prolonged ( >2 minutes) cardiopulmonary resuscitation, childbirth, or non-stressful vascular puncture (such as subclavian or jugular vein puncture);
  • Stroke episode occurred with epileptic seizure;
  • History of stroke comorbid with diabetes;
  • History of stroke over the past 3 months；
  • Acute bleeding tendency, including platelet count below 100×10⁹/L or other conditions;
  • SBP >185 mmHg or DBP >110 mmHg, or requiring intensive treatment (intravenous antihypertensive drugs) to lower blood pressure to within limits;
  • Blood glucose <2.8 mmol/L or >22.2 mmol/L (<50 mg/dL or >400 mg/dL)；
  • Patient life expectancy of less than 1 year;
  • Simultaneous occlusion of multiple blood vessels, defined as bilateral MCAs or MCAs combined with the basilar artery;
  • Pregnant women or nursing mothers；
  • Patients with a low likelihood of 3-month follow-up；
  • Over the past 3 months participated in other interventional clinical trials.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wei Hu, MD, PhD contact

+86 055162284313

andinghu@ustc.edu.cn

China1 site

  • The First Affiliated Hospital of University of Science and Technology of China

    Hefei, Anhui

    Wei Hu, MD,PhD, +8615155510611, andinghu@ustc.edu.cn

Other trials in China

About this study

Official title: Tenecteplase vs Medical Management in 4.5-24h Anterior Circulation Large Vessel Occlusion With no Access to EVT

The goal of this clinical trial is to learn if tenectplase works to acute ischemic stroke (AIS) with onset 4.5-9 hours. It will also learn about the safety of tenectplase in AIS with onset 4.5-9 hours. The main question it aims to answer is: Does tenectplase improve the 90-days functional outcome in participants with acute large vessel occlusion? Researchers will compare tenectplase thrombolysis to non-use to see if tenectplase works to improve the functional outcome in participants with onset 4.5-9 hours. Participants will:* Receive 0.25mg/kg (max 25mg) tenectplase at admission (after randomization) .* Receive neurological assessment at admission, Day 5-7 or on hospital discharge (whichever earlier). Audio or video of the assessment may be recorded if possible.* Receive brain CT + CT angiogram + CT perfusion and MRI after randomization, where the CT scan may be repetitive.

Being tested
TNK, Standard medical treatment
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TNKDrug

    Also called tenecteplase

    a dose of 0.25 mg/kg (max 25 mg) administered as a bolus

  • Standard medical treatmentDrug

    Also called standard treatment

    antiplatelet drugs, anticoagulation or combinations of these treatment modality according to national and institutional guidelines.

Study groups in NCT07168278
Study groupRoleWhat they receive
TNKExperimentalParticipants will receive intravenous tenecteplase at a dose of 0.25 mg/kg (max 25 mg) administered as a bolus after enrollment. Subsequent treatment will be administered with antiplatelet drugs, anticoagulation or combinations of these treatment modality according to national and institutional guidelines.
Receives: Drug: TNK
Standard medical managementPlacebo comparatorParticipants will receive antiplatelet drugs, anticoagulation or combinations of these treatment modality according to national and institutional guidelines.
Receives: Drug: Standard medical treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with functional independence outcome (mRS 0-2) at day 90

    modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)

    Measured: 90 days after procedure

Secondary outcomes (5)

  1. The ordinal shift of modified Rankin Scale

    The Modified Rankin Scale (mRS) measures degree of disability/dependence after a stroke, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death

    Measured: 90 days after procedure

  2. Proportion of patients with functional independence outcome (mRS 0-1) at day 90

    Modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)

    Measured: 90 days after procedure

  3. Recanalization of occlusion site according to the arterial occlusive lesion (AOL) scale

    It specifically measures the mechanical success of recanalization at the site of the original occlusion.The scale ranges from 0 to 3, with higher scores indicating better recanalization. Grade 0: No recanalization (persistent occlusion). Grade 1: Incomplete recanalization (partial reopening with minimal flow). Grade 2: Partial recanalization (significant flow but residual stenosis or thrombus). Grade 3: Complete recanalization (full restoration of flow with no residual occlusion).

    Measured: 24 hours after randomization

  4. Change in Neurological Function of Participants Assessed by National Institute of Health Stroke Scale

    Zero indicates no stroke symptoms, 1-4 , 5-15, 16-20, 21-42 indicate minor, moderate, moderate to severe, and severe stroke, respectively.

    Measured: Baseline and 7-days after randomization (or at discharge)

  5. Symptomatic intracranial hemorrhage (SICH) as defined by the Heidelberg Bleeding Classification

    SICH means any hemorrhage with neurological deterioration, as indicated by an NIHSS score that was higher by ≥4 points than the value at baseline or the lowest value in the first 24 hours , or any hemorrhage leading to death.

    Measured: within 36 hours after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2025
  2. Study start1 Nov 2025 (estimated)
  3. Primary completion1 Mar 2028 (estimated)
  4. Study completion31 May 2028 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
794 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07168278
Sponsor's protocol ID
2025KY348
Acronym
TNK LATE
Status last verified
Sep 2025
First submitted
5 Sep 2025
Last updated
11 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TNK and Standard medical treatment in people with Acute Ischemic Stroke and Large Vessel Occlusion, 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 8 inclusion and 24 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 11 Sep 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 (+86 055162284313, 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 functional independence outcome (mRS 0-2) at day 90 (time frame: 90 days after procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07168278.

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 11 Sep 2025.

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