Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07253181

Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours

Led by Xuanwu Hospital, Beijing · Updated on 2026-03-19

572

Participants Needed

2

Research Sites

116 weeks

Total Duration

On this page

Sponsors

X

Xuanwu Hospital, Beijing

Lead Sponsor

B

Boehringer Ingelheim (China) Investment Co., Ltd

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study will address the efficacy and safety of Tenecteplase administered in non-endovascular capable center (nECC) in patients with acute ischemic stroke (AIS) caused by anterior circulation large vessel occlusion (acLVO) who present in the 4.5- to 24-hour time window before interhospital transfer to an endovascular capable center (ECC) for endovascular treatment (EVT). * Primary objective: To evaluate the efficacy and safety of Tenecteplase administration at a nECC before EVT transfer compared with standard of care * Secondary objective: To evaluate the impact of time from needle-to-arterial puncture on clinical outcomes Patients who meet inclusion criteria will be randomized to Tenecteplase (0.25mg/kg, maximum 25mg) before transfer or standard of care. A single bolus dose should be injected over 5 seconds.

CONDITIONS

Official Title

Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age of 18 years or older
  • Stroke symptom onset to treatment initiation within 4.5 to 24 hours (time last known well)
  • Acute anterior circulation ischemic stroke involving occlusion of the internal carotid artery or middle cerebral artery (M1 or M2)
  • Functionally independent (modified Rankin Scale 0-2) before stroke
  • Baseline NIH Stroke Scale score between 6 and 25
  • Planned transfer to endovascular capable centers for endovascular treatment
  • Written informed consent from patient or legal representative
  • Neuroimaging confirmation of vessel occlusion and target mismatch profile on CT or MR perfusion, or alternative imaging criteria including DWI-FLAIR mismatch or ASPECTS score 7 on CT or MRI
Not Eligible

You will not qualify if you...

  • Allergy or hypersensitivity to Tenecteplase
  • Intended to receive intravenous thrombolysis as standard care
  • Rapidly improving symptoms with NIH Stroke Scale score less than 6 before randomization
  • Any contraindications for intravenous thrombolysis except time criteria
  • Known bleeding disorders or impaired coagulation due to disease or anticoagulants
  • Use of warfarin with INR >1.7 or prothrombin time >15s, recent use of direct oral anticoagulants within 48 hours, or full dose heparin within 24 hours
  • Ischemic stroke or myocardial infarction within previous 3 months
  • Previous intracranial hemorrhage or active internal bleeding within previous 3 months
  • Severe uncontrolled high blood pressure (systolic >180 mmHg or diastolic >110 mmHg)
  • Serious advanced or terminal illness with life expectancy under 6 months
  • Baseline blood glucose below 50 mg/dl or above 400 mg/dl
  • Contraindications to contrast imaging
  • Multiple acute arterial occlusions in different vascular territories
  • Extensive early ischemic changes affecting more than one-third of MCA territory or invalidating mismatch criteria
  • Evidence of intracranial tumor, acute hemorrhage, or arteriovenous malformation
  • Current participation in another investigational drug or device study
  • Suspected infective endocarditis
  • Any condition deemed hazardous by the investigator for study participation or therapy initiation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China, 100053

Actively Recruiting

2

Affiliated Hospital of Shandong Second Medical University

Weifang, Shandong, China, 261031

Actively Recruiting

Loading map...

Research Team

G

Gaoting Ma, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here