Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusive Stroke(TNK-LVO) :a Phase 3, Multicentre, Open-label, Randomised Controlled Trial
Overview
- Phase
- Phase 3
- Intervention
- Tenecteplase
- Conditions
- Stroke, Ischemic
- Sponsor
- Xuanwu Hospital, Beijing
- Enrollment
- 850
- Locations
- 2
- Primary Endpoint
- mRS ≤ 2 at 90 days or no change from baseline
- Status
- Recruiting
- Last Updated
- 23 days ago
Overview
Brief 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.
Detailed Description
Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusive Stroke(TNK-LVO) is a phase III, multicenter, prospective, randomized, open-label, blinded-endpoint clinical trial. Randomization will be 1:1 according to reperfusion treatment modalities: (A) Intravenous thrombolysis with tenecteplase (0.25 mg/kg) plus mechanical thrombectomy vs. (B) Intravenous thrombolysis with alteplase (0.9 mg/kg) plus mechanical thrombectomy. For the primary outcome, the subjects will be followed up within 90 days after randomization. The primary outcome will be the Functional independence defined as modified Rankin Score ≤ 2.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 ≤
- •Informed consent from the patient or legally authorised representative.
Exclusion Criteria
- •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.
- •History of severe head trauma or stroke within the past 3 months.
- •Intracranial or intraspinal surgery within the past 3 months.
- •Major surgery within the past 2 weeks.
- •Gastrointestinal or urinary tract bleeding within the past 3 weeks.
- •Intracranial tumor, arteriovenous malformation, or giant intracranial aneurysm.
- •Active visceral bleeding.
Arms & Interventions
tenecteplase
Subjects assigned to this arm will receive an intravenous bolus of 0.25mg/kg tenecteplase before the mechanical thrombectomy.
Intervention: Tenecteplase
alteplase
Subjects assigned to this arm will receive an intravenous 0.9 mg/kg alteplase(10% bolus +90% infusion/1 hour) before the mechanical thrombectomy.
Intervention: Alteplase
Outcomes
Primary Outcomes
mRS ≤ 2 at 90 days or no change from baseline
Time Frame: 90 days from baseline
mRS ≤ 2 at 90 days or no change from baseline
Secondary Outcomes
- mTICI 2b/3 or absence of retrievable thrombus at initial angiogram(initial angiogram)
- mRS at 90 days from baseline(90 days from baseline)
- mRS 0-1 at 90 days or no change from baseline(90 days from baseline)
- Barthel index at 90 days from baseline(90 days from baseline)
- NIHSS reduce ≥ 8 or reaching 0-1 at 3 days from baseline(3 days from baseline)
- Change of NIHSS at 1、3、7 days from baseline(1、3、7 days from baseline)