Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke

Phase 3

Not yet recruiting

• Conditions: Stroke, Ischemic; Stroke, Acute; Thrombosis, Brain; Drug Effect
• Interventions: Drug: Tenecteplase; Drug: Alteplase

• Registration Number: NCT06658197
• Lead Sponsor: Xuanwu Hospital, Beijing

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.

Study Timeline

• Study First Submitted: 2024-10-23
• Study First Submitted QC: 2024-10-23
• Study First Posted: 2024-10-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-30
• Last Update Posted: 2024-12-31
• Study Start: 2025-02-02
• Primary Completion: 2026-12-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 850

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tenecteplase	Tenecteplase	Subjects assigned to this arm will receive an intravenous bolus of 0.25mg/kg tenecteplase before the mechanical thrombectomy.
alteplase	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.

Primary Outcome Measures

Name	Time	Method
mRS ≤ 2 at 90 days or no change from baseline	90 days from baseline	mRS ≤ 2 at 90 days or no change from baseline

Secondary Outcome Measures

Name	Time	Method
mTICI 2b/3 or absence of retrievable thrombus at initial angiogram	initial angiogram	mTICI 2b/3 or absence of retrievable thrombus at initial angiogram
mRS at 90 days from baseline	90 days from baseline	mRS at 90 days from baseline
mRS 0-1 at 90 days or no change from baseline	90 days from baseline	mRS 0-1 at 90 days or no change from baseline
Barthel index at 90 days from baseline	90 days from baseline	Barthel index at 90 days from baseline
NIHSS reduce ≥ 8 or reaching 0-1 at 3 days from baseline	3 days from baseline	NIHSS reduce ≥ 8 or reaching 0-1 at 3 days from baseline
Change of NIHSS at 1、3、7 days from baseline	1、3、7 days from baseline	Change of NIHSS at 1、3、7 days from baseline

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China