Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusive Stroke(TNK-LVO) :a Phase 3, Multicentre, Open-label, Randomised Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Age is 18-80 years.

• AIS symptom onset ≤4.5 hours, onset time refers to the time the patient was last known to be well. (Recommendation time from thrombolysis to puncture within 60 minutes).

• Arterial occlusion of the internal carotid artery (ICA), anterior cerebral artery (ACA), posterior cerebral artery (PCA), M1 or M2 segment of the middle cerebral artery (MCA), or basilar artery on computed tomography angiography (CTA) or magnetic resonance angiography (MRA).

• Prestroke mRS score ≤2.

• Informed consent from the patient or legally authorised representative.

Locations
Other Locations
China
Xuanwu Hospital, Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Lu Wang, MD
wanglu3261999@163.com
13161090533
Backup
Xiuhai Guo, MD
guoxhxuan@126.com
18810285127
Time Frame
Start Date: 2025-12-25
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 850
Treatments
Experimental: tenecteplase
Subjects assigned to this arm will receive an intravenous bolus of 0.25mg/kg tenecteplase before the mechanical thrombectomy.
Active_comparator: alteplase
Subjects assigned to this arm will receive an intravenous 0.9 mg/kg alteplase(10% bolus +90% infusion/1 hour) before the mechanical thrombectomy.
Related Therapeutic Areas
Sponsors
Leads: Xuanwu Hospital, Beijing

This content was sourced from clinicaltrials.gov