Tenecteplase before transfer for basilar artery stroke 4.5–24 hours after symptom onset

Intravenous Tenecteplase Before Interhospital Transfer for Thrombectomy in Acute Basilar Artery Occlusion at 4.5 to 24 Hours

This trial tests whether giving IV tenecteplase before transfer helps people with basilar artery occlusion who are 4.5–24 hours from symptom onset and are being sent for thrombectomy.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 316 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07203625 on ClinicalTrials.gov

What this trial studies

This multicenter, prospective, open-label, blinded-endpoint randomized trial enrolls adults presenting to non-endovascular-capable centers with CTA/MRA-confirmed basilar artery occlusion 4.5–24 hours after symptom onset. Eligible patients (NIHSS ≥6, premorbid mRS 0–2) are randomized to receive intravenous tenecteplase 0.25 mg/kg (maximum 25 mg) before interhospital transfer or to not receive tenecteplase prior to transfer. All participants are intended to undergo thrombectomy at an endovascular-capable center, and outcomes are adjudicated by blinded reviewers. The trial captures safety and functional outcomes to see if pre-transfer thrombolysis improves reperfusion and recovery.

Who should consider this trial

Good fit: Adults with imaging-confirmed basilar artery occlusion presenting 4.5–24 hours after symptom onset, with NIHSS ≥6, premorbid mRS 0–2, and planned transfer for thrombectomy are ideal candidates.

Not a fit: Patients who present beyond 24 hours, have high bleeding risk, very mild deficits, or who are already at an endovascular-capable center are unlikely to benefit from this pre-transfer treatment approach.

Why it matters

Potential benefit: If successful, starting tenecteplase before transfer could increase early reperfusion and improve functional recovery after basilar artery occlusion.

How similar studies have performed: Previous trials have shown tenecteplase can be as effective or superior to alteplase for some large-vessel anterior circulation strokes, but using tenecteplase specifically before transfer for late-window basilar artery occlusion is largely untested.

Eligibility criteria

Inclusion Criteria:

* Age ≥18 years;
* Patients presenting with posterior circulation ischemic stroke symptoms due to BAO;
* BAO confirmed by computed tomographic angiography (CTA)/ magnetic resonance angiography (MRA);
* Time from AIS symptom onset to randomization within 4.5-24 hours, stroke onset is defined as the onset of acute symptoms leading to the clinical diagnosis of basilar artery occlusion (BAO) not considering the time of any preceding minor prodromal symptoms (such as isolated vertigo, diplopia or sensory changes) as onset time or, if not known, the time the patient was last known to be well (including wake-up stroke and unwitnessed stroke);
* Baseline National Institute of Health Stroke Scale (NIHSS) score obtained prior to randomization ≥6;
* Functionally independent (modified Rankin Scale \[mRS\] 0-2) prior to stroke onset;
* Intended to transfer for thrombectomy. Two paradigms are allowed in this study: (1)transferring patients to ECC (patient transfer); (2)travelling neurointerventionist to nECC (physician transfer);
* Written informed consent from patients or legally responsible representatives

Exclusion Criteria:

* Posterior Circulation Acute Stroke Prognosis Early CT score (PC-ASPECTS) \< 6 on computed tomography (CT)/CTA-Source Images/MRI with diffusion-weighted imaging (DWI)
* CT/MR shows evidence of intracranial hemorrhage and tumor (except small meningioma)
* Complete cerebellar infarct on CT/MRI with significant mass effect and compression of the 4th ventricle
* Bilateral extensive brainstem infarction on CT/MRI
* Simultaneous occlusion of both anterior and posterior circulation confirmed by CTA/MRA/DSA (patients with a history of occlusion of anterior circulation more than three months ago can be included)
* Treatment with a thrombolytic within the last 72 hours or intention to receive intravenous thrombolysis
* Known hypersensitivity or allergy to any ingredients of Tenecteplase
* Any other contra-indication for intravenous thrombolysis except for the time criteria
* Known hereditary or acquired hemorrhagic diathesis
* Impairment in coagulation due to comorbid disease or anticoagulant use. If on warfarin, international normalized ratio (INR) \>1.7 or prothrombin time \>15s; if use of any direct oral anticoagulant within the last 48 hours; if use of heparin/heparinoid within the last 24 hours
* Ischemic stroke or myocardial infarction in previous 3 months
* Previous intracranial hemorrhage, active internal bleeding (gastrointestinal or urinary tract hemorrhage) in previous 3 months
* Severe, uncontrolled hypertension (systolic blood pressure \>185mmHg or diastolic blood pressure \>110mmHg)
* Baseline blood glucose \<50mg/dl or \>400mg/dl
* Baseline platelet count \<100,000/μL
* Undergoing hemodialysis or peritoneal dialysis; known severe renal insufficiency with glomerular filtration rate \<30mL/min or serum creatinine \>220mmol/L (2.5mg/dL)
* Known severe, life-threatening allergy (more severe than skin rash) to contrast agents
* Patients with acute stroke within the first 48 hours after percutaneous cardiac, cerebrovascular interventions and major surgery
* Known diagnosis or clinical suspicion of cerebral vasculitis
* Known diagnosis or clinical suspicion of endocarditis
* Pregnancy or lactating;
* Other serious, advanced or terminal illness with life expectancy less than 6 months
* Current participation in any investigational study that may confound outcome assessment of the study
* Any condition that, in the judgement of the investigator, is inappropriate for participation in the trial or could impose hazards to the patient (e.g. inability to understand and/or follow the study procedures and/or follow-up due to mental disorders, cognitive or emotional disorders)

Where this trial is running

Beijing

• Xuanwu Hospital, Capital Medical University — Beijing, China (RECRUITING)

Study contacts

• Principal investigator: Junwei Hao, MD — Xuanwu Hospital, Beijing
• Study coordinator: Junwei Hao, MD

Conditions: Acute Ischemic Stroke, Basilar Artery Occlusion, basilar artery occlusion, thrombolysis, interhospital transfer