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

NCT07168278 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 2025KY348
• Study Type: interventional
• Target: 794
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Acute Ischemic Stroke; Large Vessel Occlusion; Tenecteplase; Thrombolysis

Outcome Measures

Primary Outcomes (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)

  90 days after procedure

Secondary Outcomes (5)

• The ordinal shift of modified Rankin Scale

  90 days after procedure

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

  90 days after procedure

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

  24 hours after randomization

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

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

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

  within 36 hours after randomization

Study Arms (2)

TNK

EXPERIMENTAL

Participants 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.

Drug: TNK

Standard medical management

PLACEBO COMPARATOR

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

Drug: Standard medical treatment

Interventions

TNK DRUG

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

Also known as: tenecteplase

TNK

Standard medical treatment DRUG

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

Also known as: standard treatment

Standard medical management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

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

Hefei, Anhui, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Tenecteplase

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tissue Plasminogen Activator; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Wei Hu, MD, PhD

CONTACT

+86 055162284313; andinghu@ustc.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 11, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)