NCT07203625 Tenecteplase Before Interhospital Transfer in Acute Basilar Artery Occlusion at 4.5 to 24 Hours
| NCT ID | NCT07203625 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Xuanwu Hospital, Beijing |
| Condition | Acute Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 316 participants |
| Start Date | 2026-01-20 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 316 participants in total. It began in 2026-01-20 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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)
Contact & Investigator
Junwei Hao, MD
PRINCIPAL INVESTIGATOR
Xuanwu Hospital, Beijing
Frequently Asked Questions
Who can join the NCT07203625 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07203625 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07203625 currently recruiting?
Yes, NCT07203625 is actively recruiting participants. Contact the research team at haojunwei@vip.163.com for enrollment information.
Where is the NCT07203625 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07203625 clinical trial?
NCT07203625 is sponsored by Xuanwu Hospital, Beijing. The principal investigator is Junwei Hao, MD at Xuanwu Hospital, Beijing. The trial plans to enroll 316 participants.
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