Clinical trial NCT06658197: Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Stroke, Ischemic
Stroke, Acute
Thrombosis, Brain
Drug Effect
Keywords: Ischemic stroke
Tenecteplase
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Age is 18-80 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 on CTA of the ICA, ACA, PCA, M1, M2 or basilar.
4. Prestroke mRS score ≤2.
5. Informed consent from the patient or legally authorised representative.

Exclusion Criteria:

1. ICH, subarachnoid haemorrhage or other brain haemorrhage identified by CT.
2. NIHSS consciousness score (NIHSS 1a) \>2.
3. Contraindication to imaging with contrast agents.
4. Intraventricular haemorrhage, subarachnoid haemorrhage, subdural/external haematoma, etc) in previous 3 months.
5. Severe brain trauma or ischaemic stroke in previous 3 months.
6. Intracranial or intraspinal surgery in previous 3 months.
7. Major surgery within the previous 14 days.
8. Gastrointestinal or urinary tract haemorrhage within the previous 21 days.
9. Known malignant intracranial neoplasm, giant intracranial aneurysm or arteriovenous malformation.
10. Known active visceral bleeding.
11. Known aortic arch dissection.
12. Arterial puncture at a non-compressible site within the previous 7 days.
13. Persistent blood pressure elevation (systolic ≥180 mm Hg or diastolic ≥100 mm Hg), despite blood pressure lowering treatment.
14. Known defect of platelet or clotting function, platelet count below 100×109/L (note that patients on antiplatelet agents can be included).
15. Use of heparins during the last 48 hours.
16. Any known defect in coagulation, for example, current use of oral warfarin anticoagulant with an international normalised ratio \>1.7 or prothrombin time \>15 s.
17. Use of direct thrombin inhibitors or direct factor Xa inhibitors during the last 48 hours.
18. Blood glucose \<2.8 mmol/L or \>22.22 mmol/L (point-of-care glucose testing is acceptable).
19. Hypodensity in \>1/3 middle cerebral artery territory on non-contrast computer tomography (NCCT).
20. Rapidly improving symptoms at the discretion of the investigator.
21. Participation in another clinical trial within the previous 3 months.
22. Any terminal illness such that patient would not be expected to survive \>1 year.

Primary outcomes:
measure: mRS ≤ 2 at 90 days or no change from baseline
timeFrame: 90 days from baseline
Secondary outcomes:
measure: mTICI 2b/3 or absence of retrievable thrombus at initial angiogram
timeFrame: initial angiogram
measure: mRS at 90 days from baseline
timeFrame: 90 days from baseline
measure: mRS 0-1 at 90 days or no change from baseline
timeFrame: 90 days from baseline
measure: Barthel index at 90 days from baseline
timeFrame: 90 days from baseline
measure: NIHSS reduce ≥ 8 or reaching 0-1 at 3 days from baseline
timeFrame: 3 days from baseline
measure: Change of NIHSS at 1、3、7 days from baseline
timeFrame: 1、3、7 days from baseline
Other outcomes:
measure: sICH within 36 hours from baseline
timeFrame: 36 hours from baseline
measure: Vascular death within 90 days from baseline
timeFrame: Within 90 days from baseline
measure: Death from any cause within 90 days from baseline
timeFrame: Within 90 days from baseline
measure: SAEs within 90 days from baseline
timeFrame: Within 90 days from baseline
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Xiuhai Guo, MD
role: PRINCIPAL_INVESTIGATOR
References: