Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vesse
A phase III, multicentre, prospective, randomised, open-label, blinded-endpoint clinical trial will evaluate two thrombolytic agents for the treatment of acute large vessel occlusion stroke within 4.5 hours from symptoms onset: intravenous tenecteplase bridging mechanical thrombectomy vs. intravenous alteplase bridging
| Condition(s) | Stroke, Ischemic, Stroke, Acute, Thrombosis, Brain, Drug Effect |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | A phase III, multicentre, prospective, randomised, open-label, blinded-endpoint clinical trial will evaluate two thrombolytic agents for the treatment of acute large vessel occlusion stroke within 4.5 hours from symptoms onset: intravenous tenecteplase bridging mechanical thrombectomy vs. intravenous alteplase bridging mechanical thrombectomy. |
| Who can participate | Inclusion Criteria: 1. Age is ≥18 years. 2. AIS symptom onset ≤4.5 hours, onset time refers to the time the patient was last known to be well. (Recommendation time from thrombolysis to puncture within 60 minutes). 3. Arterial occlusion of the internal carotid artery (ICA), anterior cerebral artery (ACA), posterior cerebral artery (PCA), M1 or M2 segment of the middle cerebral artery (MCA), or basilar artery on computed tomography angiography (CTA) or magnetic resonance angiography (MRA). 4. Prestroke mRS score ≤2. 5. Informed consent from the patient or legally authorised representative. Exclusion Criteria: 1. Patients diagnosed with hemorrhagic stroke (including intraparenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.) or other |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Xuanwu Hospital, Beijing |
| Locations | Beijing, Beijing Municipality, China |
| Start date | 2025-12-25 |
| NCT ID | NCT06658197 |
| Official listing | https://clinicaltrials.gov/study/NCT06658197 |