Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06658197

Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke

Led by Xuanwu Hospital, Beijing · Updated on 2026-04-09

850

Participants Needed

1

Research Sites

74 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

A phase III, multicentre, prospective, randomised, open-label, blinded-endpoint clinical trial will evaluate two thrombolytic agents for the treatment of acute large vessel occlusion stroke within 4.5 hours from symptoms onset: intravenous tenecteplase bridging mechanical thrombectomy vs. intravenous alteplase bridging mechanical thrombectomy.

CONDITIONS

Official Title

Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age is 18 years or older.
  • Stroke symptoms started within 4.5 hours; time is from when patient was last known well.
  • Arterial blockage in internal carotid, anterior cerebral, posterior cerebral, middle cerebral (M1 or M2), or basilar artery confirmed by CT or MRI angiography.
  • Prestroke modified Rankin Score of 2 or less.
  • Informed consent provided by patient or authorized representative.
Not Eligible

You will not qualify if you...

  • Hemorrhagic stroke or brain bleeding detected by CT.
  • Contraindication to contrast imaging exams.
  • Coma symptoms (NIHSS Score Item 1a = 3).
  • History of intracranial hemorrhage.
  • Severe head trauma or stroke within past 3 months.
  • Brain or spinal surgery within past 3 months.
  • Major surgery within past 2 weeks.
  • Gastrointestinal or urinary bleeding within past 3 weeks.
  • Brain tumor, arteriovenous malformation, or large brain aneurysm.
  • Active internal bleeding.
  • Aortic arch dissection.
  • Arterial puncture at non-compressible site within past week.
  • Uncontrolled high blood pressure despite treatment (systolic >180 mmHg or diastolic >100 mmHg).
  • Blood clotting disorders or platelet count below 100 x 10⁹/L.
  • Heparin treatment within past 24 hours.
  • Oral anticoagulants with INR >1.7 or PT >15 seconds.
  • Use of direct thrombin or Factor Xa inhibitors within past 48 hours.
  • Blood sugar below 2.8 mmol/L or above 22.2 mmol/L.
  • Large brain area damage on CT affecting more than one third of the middle cerebral or basilar artery territory.
  • Rapidly improving symptoms.
  • Participation in another study within past 30 days.
  • Terminal illness with life expectancy less than 1 year.
  • Any condition posing risk or affecting study participation.
  • Pregnant women.
  • Known allergy to alteplase, tenecteplase, or any excipients.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100053

Actively Recruiting

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Research Team

L

Lu Wang, MD

CONTACT

X

Xiuhai Guo, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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