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

NCT ID: NCT06658197

Last Updated: 2024-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

850 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-02

Study Completion Date

2027-06-01

Brief Summary

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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

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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.

Conditions

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Stroke, Ischemic Stroke, Acute Thrombosis, Brain Drug Effect

Keywords

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Ischemic stroke Tenecteplase

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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tenecteplase

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

Group Type EXPERIMENTAL

Tenecteplase

Intervention Type DRUG

Tenecteplase 0.25mg/kg administered as a single rapid intravenous bolus (maximum dose 25mg) plus mechanical thrombectomy

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.

Group Type ACTIVE_COMPARATOR

Alteplase

Intervention Type DRUG

Alteplase 0.9 mg/kg administered as 10% bolus +90% infusion/1 hour (maximum dose 90mg) plus mechanical thrombectomy

Interventions

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Tenecteplase

Tenecteplase 0.25mg/kg administered as a single rapid intravenous bolus (maximum dose 25mg) plus mechanical thrombectomy

Intervention Type DRUG

Alteplase

Alteplase 0.9 mg/kg administered as 10% bolus +90% infusion/1 hour (maximum dose 90mg) plus mechanical thrombectomy

Intervention Type DRUG

Other Intervention Names

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TNK recombinant tissue plasminogen activator (rtPA)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiuhai Guo, MD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

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Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Lu Wang, MD

Role: CONTACT

Phone: 13161090533

Email: [email protected]

Xiuhai Guo, MD

Role: CONTACT

Phone: 18810285127

Email: [email protected]

Facility Contacts

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Lu Wang, MD

Role: primary

Xiuhai Guo, MD

Role: backup

Xiuhai Guo, MD

Role: backup

Other Identifiers

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[2024]288-001

Identifier Type: -

Identifier Source: org_study_id