Tenecteplase Before Interhospital Transfer in Acute Basilar Artery Occlusion at 4.5 to 24 Hours (OPTION-2)

Capital Medical University

Status and phase: Enrolling; Phase 4

Conditions: Basilar Artery Occlusion; Acute Ischemic Stroke

Treatments: Drug: Tenecteplase thrombolysis

Study type: Interventional

Funder types: Other

Identifiers

NCT07203625

XMEC-2025-003

Details and patient eligibility

About

This study is designed to investigate the efficacy and safety of intravenous tenecteplase before interhospital transfer from a non-endovascular capable center(nECC) to an endovascular capable center (ECC) for thrombectomy in patients with acute ischemic stroke (AIS) caused by neuroimaging-confirmed acute basilar artery occlusion (BAO) between 4.5-24 hours of symptom onset.

Full description

This is a multicenter, prospective, open-label, blinded endpoint (PROBE), randomized controlled trial in patients with acute ischemic stroke due to BAO first presenting to a nECC and intending to undertake thrombectomy in an ECC.

Patients will be required to have occlusion of the basilar artery on baseline computed tomography angiography (CTA)/magnetic resonance angiography (MRA) at the nECC. Patients will be randomized to either intravenous tenecteplase (0.25mg/kg, maximum 25mg)or not before interhospital transfer.

Enrollment: 316 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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316 participants in 2 patient groups

Interventional group

Experimental group

Description:

Patients will receive intravenous Tenecteplase 0.25 mg/kg body-weight up to a maximum of 25mg before the interhospital transfer or the physician departure. A single bolus dose should be administered over 5-10 seconds based on patient weight. Transfer to ECCs or physician travelling for thrombectomy should be initiated immediately after Tenecteplase administration.

Treatment:

Drug: Tenecteplase thrombolysis

Control group

No Intervention group

Description:

Patients will receive standard treatment and be directly transferred to ECCs or transfer physician for EVT according to Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2023.