Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorXuanwu Hospital, Beijing
About this trial
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.
Eligibility criteria
Qualifiers
Age is ≥18 years.
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).
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).
Prestroke mRS score ≤2.
Disqualifiers
Patients diagnosed with hemorrhagic stroke (including intraparenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.) or other related conditions identified by CT.
Contraindication to imaging examinations involving contrast agent injection.
Patients presenting with clinical symptoms of coma (NIHSS Score Item 1a = 3).
History of intracranial hemorrhage.
Trial design
Treatments tested in this trial
- Tenecteplase
- Alteplase
Treatment groups
850 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov