Tenecteplase Before Hospital Transfer for Stroke Caused by a Large Blocked Brain Artery

Trial details

Who runs it

Fujian Medical University Union Hospital

Trial code

NCT07912970

Record updated

3 November 2026

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: Participants must meet all of the following criteria:; Age ≥18 years; Time from stroke onset or last known well to randomization >4.5 hours and ≤24 hours; Diagnosis of acute ischemic stroke with a baseline NIHSS score ≥6 before randomization; Pretreatment CTA or MRA demonstrating occlusion of the M1 segment or the proximal M2 segment of the dominant division of the MCA, identified as the target vessel responsible for the presenting stroke; A small infarct volume demonstrated by either of the following imaging criteria: Alberta Stroke Program Early CT Score (ASPECTS) ≥7 for MCA-M1 occlusion or ASPECTS 9-10 for MCA-M2 occlusion; or CTP or MRP demonstrating salvageable ischemic brain tissue and meeting all of the following criteria: (1) Infarct-core volume, defined as relative cerebral blood flow (rCBF) <30% or an apparent diffusion coefficient (ADC) <620 × 10-⁶ mm²/s on diffusion-weighted imaging (DWI), ≤70 mL; (2) Ischemic mismatch volume, defined as the volume with Tmax >6 seconds minus the infarct-core volume, ≥15 mL; (3) Ratio of ischemic-tissue volume to infarct-core volume ≥1.8; Prestroke mRS score of 0-2; Planned interhospital transfer to a thrombectomy-capable stroke center for EVT; The estimated interval from randomization to arterial puncture at the EVT center is ≥90 minutes; Written informed consent provided by the participant or the participant's legally authorized representative.

Exclusion: Intracranial hemorrhage confirmed by CT or MRI, including intraparenchymal, intraventricular, subarachnoid, subdural, or epidural hemorrhage; Participants meeting any of the following criteria will be excluded:; Any contraindication to intravenous thrombolysis, including: 1) Significant head trauma or stroke within the previous 3 months; 2) Symptoms suggestive of subarachnoid hemorrhage; 3) Arterial puncture at a noncompressible site within the previous 7 days; 4) History of intracranial hemorrhage; 5) Intracranial neoplasm, arteriovenous malformation, or aneurysm; 6) Recent intracranial or intraspinal surgery; 7) Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg; 8) Active internal bleeding; 9) Acute bleeding tendency, including but not limited to: Platelet count <100,000/mm³ (100 × 10⁹/L); Heparin administration within the previous 48 hours with an activated partial thromboplastin time above the upper limit of normal; Current oral anticoagulant therapy; International normalized ratio >1.7 or prothrombin time >15 seconds; or Current use of a direct thrombin inhibitor or direct factor Xa inhibitor with elevated relevant sensitive laboratory parameters, such as activated partial thromboplastin time, international normalized ratio, platelet count, ecarin clotting time, thrombin time, or an appropriate factor Xa activity assay; 10) Blood glucose <50 mg/dL (2.78 mmol/L) or >400 mg/dL (22.20 mmol/L); Note: In participants without a history of or clinical suspicion for a coagulation abnormality, enrollment need not be delayed while awaiting coagulation-test results; Pregnancy, breastfeeding, or a positive pregnancy test; Known hypersensitivity to tenecteplase, heparin, contrast media, or anesthetic agents, or any other definite contraindication to EVT; Severe arterial tortuosity or another condition that makes EVT technically infeasible; A pre-existing neurologic or psychiatric disorder that may interfere with neurologic assessment; Multiple-vessel occlusion, such as simultaneous bilateral anterior-circulation large-vessel occlusion or simultaneous anterior- and posterior-circulation large-vessel occlusion; Terminal illness associated with a life expectancy of <6 months; Anticipated inability to complete the required follow-up; Current participation in another study that may affect the assessment of outcomes in this trial; Any other condition that, in the investigator's judgment, makes the participant unsuitable for the trial; Imaging Exclusion Criteria:; A large established infarction on CT, defined as hypodensity involving more than one-third of a cerebral hemisphere; A brain tumor with mass effect on imaging, except for a small meningioma; Intracranial aneurysm or arteriovenous malformation. Suspected aortic dissection.

ClinicalTrials.gov NCT07912970