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NCT Number: NCT07168278

Tenecteplase vs Medical Management in 4.5-24h LVO 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Hefei, Anhui, China

Location contact

Wei Hu, MD,PhD

CONTACT

[email protected]

+8615155510611

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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;
  • 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.

Treatment and study plan

TNK

Drug

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

Other names: tenecteplase

Standard Medical Treatment

Drug

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

Other names: standard treatment

Primary outcomes

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

    Time frame: 90 days after procedure

    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)

Secondary outcomes

  1. The ordinal shift of modified Rankin Scale

    Time frame: 90 days after procedure

    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

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

    Time frame: 90 days after procedure

    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)

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

    Time frame: 24 hours after randomization

    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).

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

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

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

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

    Time frame: within 36 hours after randomization

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Hu, MD, PhD

CONTACT

[email protected]

+86 055162284313

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: TNK LATE

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 11, 2025
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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