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NOT YET RECRUITING
NCT07912970
PHASE3

Tenecteplase Bridging Thrombolysis Prior to Inter-hospital Transfer for Endovascular Therapy in Anterior Circulation Large Vessel Occlusion Stroke Within 4.5-24 Hours

Sponsor: Fujian Medical University Union Hospital

View on ClinicalTrials.gov

Summary

This multicenter, randomized clinical trial will assess whether intravenous tenecteplase given before interhospital transfer improves outcomes compared with direct transfer without tenecteplase. Eligible participants are adults with acute ischemic stroke caused by occlusion of the M1 segment or proximal dominant M2 segment of the middle cerebral artery, more than 4.5 hours and no more than 24 hours after symptom onset or the last known well time. Participants will be assigned in a 1:1 ratio to receive tenecteplase before transfer or to undergo direct transfer without study-related intravenous thrombolysis. At the receiving stroke center, both groups will be evaluated for endovascular therapy and treated when clinically indicated. The primary outcome is the proportion of participants with a modified Rankin Scale score of 0-2 at 90 days after randomization. The study will also assess neurological improvement, vessel reopening, intracranial hemorrhage, and other clinical outcomes.

Official title: Efficacy and Safety of Tenecteplase Thrombolysis as Bridging Thrombolysis Prior to Inter-hospital Transfer for Endovascular Therapy in Anterior Circulation Large Vessel Occlusion Stroke Within 4.5-24 Hours: A Multicenter Randomized Controlled Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1266

Start Date

2027-04-01

Completion Date

2030-03-01

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

DRUG

Tenecteplase (rhTNK-tPA) (0.25 mg/kg, to maximum of 25mg)

Tenecteplase will be administered at a dose of 0.25 mg/kg, with a maximum dose of 25 mg, as a single intravenous bolus over 5-10 seconds before interhospital transfer.

Locations (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China