2026-525280-40-00招募中3 期
Tenecteplase for the treatment of acute stroke in the late time window before inter-hospital transfer for thrombectomy: a randomized controlled trial
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 592
- 试验地点
- 53
- 主要终点
- Functional outcome at 90 days, assessed with the modified Rankin Scale (mRS) score, merging categories 5-6 in ordinal analysis. The mRS will be centrally collected by trained professionals blinded to the treatment allocation, based on a phone interview with the patient and/or caregiver.
研究概览
简要总结
To assess the efficacy of IVT with tenecteplase 0.25mg/kg initiated 4.5 to 24-hours after last time seen well on functional outcome at 90 days in AIS-LVO patients who have evidence of salvageable ischemic brain tissue on CT or MRI and who are planned for an inter-hospital transfer to undergo an endovascular procedure.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old
- •Admitted in a PSC within 4.5-to-24-hours from stroke symptom onset (or last know well time if symptom onset was not observed)
- •Baseline NIHSS score ≥6
- •Imaging evidence of a large vessel occlusion (intracranial internal carotid artery [ICA], first or second segment of the middle cerebral artery M1 or proximal M2 or basilar artery)
- •Target mismatch profile as evidenced by one of the below criteria • If perfusion imaging is available: CT- or MR-perfusion mismatch: occlusion of ICA or M1 or M2 and an estimated ischemic core volume ≤70 mL, a Tmax 6 volume ≥30 mL, a mismatch ratio ≥1.8, and a mismatch volume ≥15 mL • If perfusion imaging is not available: MRA/CTA-ASPECTS mismatch: occlusion of ICA or M1 and ASPECTS score ≥6, or M2 and ASPECTS score ≥7, or basilar and pc-ASPECTS ≥7 (ASPECTS can be assessed on DWI or non-contrast CT)
- •Patients requiring inter-hospital transfer for an endovascular procedure.
排除标准
- •Any contraindication to IVT, based on the Metalyse SmPC and the latest AHA/ASA guidelines on IVT (Prabhakaran et al. Stroke. 2026), other than the time criteria: • Persistent incapacity to lower blood pressure under 185/110 mmHg • Respiratory or hemodynamic failure • Hypersensitivity to the active substance or to any of its excipients or hypersensitivity to gentamicin (a trace residue from the manufacturing process • Known haemorrhagic diathesis • Bacterial endocarditis, pericarditis • Acute pancreatitis • Significant impairment of hepatic function, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and progressive hepatitis • Active ulcerative gastrointestinal disease • Neoplasia associated with an increased risk of haemorrhage • Known bleeding disorders, such as thrombocytopenia (platelet count < 100 G/L) or severe coagulopathy (INR > 1.7, activated partial thromboplastin time > 40s or prothrombin time > 15s) either currently or within the last 3 weeks • Treatment with effective doses of oral anticoagulants (e.g. vitamin K antagonists with an INR > 1.7) • Any history of intracerebral neoplasm • History of intracranial / spinal surgery or acute spinal cord injury within 3 months • Recent ST-segment elevation myocardial infarction within 3 months • Major non-central nervous system surgery, biopsy of a parenchymal organ or significant trauma within the last 10 days • Recent moderate to severe traumatic brain injury • Known arterial or venous malformation, except unruptured intracranial aneurysm • History of intracerebral haemorrhage within 3 months • Known cerebral amyloid angiopathy • History of acute ischaemic stroke within 3 months
- •Pre-stroke mRS > 2 (significant disability, unable to carry out all usual duties and activities independently before stroke)
- •Known pregnant or breast-feeding woman
- •Patient benefiting from legal protection
- •Participation in other interventional research (RIPH 1, clinical drug trials, clinical investigations) for the duration of their follow-up
结局指标
主要结局
Functional outcome at 90 days, assessed with the modified Rankin Scale (mRS) score, merging categories 5-6 in ordinal analysis. The mRS will be centrally collected by trained professionals blinded to the treatment allocation, based on a phone interview with the patient and/or caregiver.
Functional outcome at 90 days, assessed with the modified Rankin Scale (mRS) score, merging categories 5-6 in ordinal analysis. The mRS will be centrally collected by trained professionals blinded to the treatment allocation, based on a phone interview with the patient and/or caregiver.
次要结局
- mRS 0 to 1 at 90 days
- mRS 0 to 2 at 90 days
- Any EVT procedure performed, defined as at least one EVT pass
- eTICI score of 2b, 2c or 3 on the first angiographic run of the endovascular procedure or revised AOL 2b-3 on non-invasive arterial imaging obtained within 36 hours of randomization if the digital subtraction angiography was not performed or uninterpretable (e.g. clinical improvement during transfer)
- eTICI score of 2b, 2c or 3 on the final angiographic run of the endovascular procedure or revised AOL 2b-3 on non-invasive arterial imaging obtained within 36 hours of randomization if the digital subtraction angiography was not performed or uninterpretable (e.g. clinical improvement during transfer).
- Change in NIHSS score between baseline (time of randomization) and arrival at EVT-capable stroke center (before EVT).
- Improvement in NIHSS score between baseline (time of randomization) and 24-36 hours of ≥8 points or an NIHSS score ≤1 at 24-36 hours.
- EuroQol 5-Dimension 3-Level questionnaire (EQ-5D-3L).
- Parenchymal hemorrhage type 1 or 2 assessed according to the Heidelberg classification on a follow-up brain imaging within 36 hours of randomization.
- Any intracranial hemorrhagic transformation according to the Heidelberg classification on a brain imaging within 36 hours of randomization that is causally associated with an NIHSS increase ≥ 4 points
- All-cause death at 90 days
研究者
Coordinating investigator
Scientific
Fondation A De Rothschild
研究点 (53)
Loading locations...
相似试验
尚未招募
3 期
Unknown Time of Onset Stroke RePerfusIon Without Advanced ImagingNCT07475949First Affiliated Hospital of Guangxi Medical University352
尚未招募
3 期
Tenecteplase for Late-Window Stroke Guided by DWI-FLAIR MismatchAcute Ischemic StrokeNCT07540416The First Affiliated Hospital of Zhengzhou University564
招募中
3 期
Thrombolysis with Tenecteplase for Acute Ischemic Stroke in Patients taking Direct Oral Anticoagulants2025-521762-99-00University Medical Center Hamburg-Eppendorf668
尚未招募
3 期
Intravenous Thrombolysis With Tenecteplase Plus Thrombectomy Versus Thrombectomy Alone In Patients With A Large Ischemic Stroke: A Multicenter Randomized Controlled Trial (IVT-ALL-IN)StrokeNCT07603440Assistance Publique - Hôpitaux de Paris486
尚未招募
3 期
Efficacy and Safety of Tenecteplase Among acutE Ischemic Stroke Patients With Recent Ingestion of Direct Oral AnticoagulantNCT07621796Hackensack Meridian Health660