Efficacy and Safety of Tenecteplase Intravenous Thrombolysis in Acute Posterior Circulation Ischemic Stroke Within 4.5-24 Hours After Onset

NCT07094763 | Not Yet Recruiting DMC

• 1 other identifier: Attention-Extend IV
• Study Type: interventional
• Target: 406
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Ischemic Stroke

Keywords

TNK Intravenous Thrombolysis; Acute ischemic stroke; posterior circulation; Beyond optimal time window

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with modified Rankin Scale (mRS) score 0-1 at 90 ±14 days;

  90 ±14 days

Secondary Outcomes (11)

• Proportion of patients with mRS score 0-2 at 90 ±14 days;

  90 ±14 days

• Proportion of patients with mRS score 0-3 at 90 ±14 days;

  90 ±14 days

• Ordinal distribution of mRS score at 90 ±14 days;

  90 ±14 days

• Change in NIHSS score at 24-36 hours post-treatment

  24 hours post-treatment

• 5)Change in NIHSS score at 5-7 days post-treatment;

  5-7 days post-treatment

Study Arms (2)

standard medical management

ACTIVE COMPARATOR

standard medical management

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.

Drug: TNK plus standard medical treatment

Interventions

TNK plus standard medical treatment DRUG

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.

TNK plus standard medical treatment

standard medical management DRUG

standard medical management

standard medical management

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Hefei, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Wei Hu MD,PhD

CONTACT

+86055162284313; andinghu@ustc.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: July 23, 2025
• First Posted: July 30, 2025
• Study Start: August 5, 2025
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)