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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Tenecteplase
DrugTenecteplase 0.25mg/kg administered as a single rapid intravenous bolus (maximum dose 25mg) plus mechanical thrombectomy
Alteplase
DrugAlteplase 0.9 mg/kg administered as 10% bolus +90% infusion/1 hour (maximum dose 90mg) plus mechanical thrombectomy
Treatment groups
850 Participants
are divided into 2 treatment groupsGroup A: tenecteplaseExperimental treatment 1 intervention
Group B: alteplaseActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
mRS ≤ 2 at 90 days or no change from baseline
mRS ≤ 2 at 90 days or no change from baseline
Time frame
90 days from baselineSecondary outcomes
1
mTICI 2b/3 or absence of retrievable thrombus at initial angiogram
mTICI 2b/3 or absence of retrievable thrombus at initial angiogram
Time frame
initial angiogram2
mRS at 90 days from baseline
mRS at 90 days from baseline
Time frame
90 days from baseline3
mRS 0-1 at 90 days or no change from baseline
mRS 0-1 at 90 days or no change from baseline
Time frame
90 days from baseline4
Barthel index at 90 days from baseline
Barthel index at 90 days from baseline
Time frame
90 days from baselineOther outcomes
1
sICH within 36 hours from baseline
Defined by Safe Implementation of Thrombolysis in Stroke and The European Cooperative Acute Stroke Study III
Time frame
36 hours from baseline2
Vascular death within 90 days from baseline
Death from stroke, heart attack or pulmonary embolism
Time frame
Within 90 days from baseline3
Death from any cause within 90 days from baseline
Death from any cause within 90 days from baseline
Time frame
Within 90 days from baseline4
SAEs within 90 days from baseline
Severe adverse events within 90 days from baseline
Time frame
Within 90 days from baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov