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

NCT ID: NCT06658197

Last Updated: 2025-12-24

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

2025-12-02

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. Patients diagnosed with hemorrhagic stroke (including intraparenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.) or other related conditions identified by CT.
2. Contraindication to imaging examinations involving contrast agent injection.
3. Patients presenting with clinical symptoms of coma (NIHSS Score Item 1a = 3).
4. History of intracranial hemorrhage.
5. History of severe head trauma or stroke within the past 3 months.
6. Intracranial or intraspinal surgery within the past 3 months.
7. Major surgery within the past 2 weeks.
8. Gastrointestinal or urinary tract bleeding within the past 3 weeks.
9. Intracranial tumor, arteriovenous malformation, or giant intracranial aneurysm.
10. Active visceral bleeding.
11. Aortic arch dissection.
12. Arterial puncture at a non-compressible site within the past week.
13. Uncontrolled hypertension despite active antihypertensive treatment: Systolic Blood Pressure \> 180 mmHg or Diastolic Blood Pressure \> 100 mmHg.
14. Acute hemorrhagic tendency, including platelet count \< 100 × 10⁹/L or other conditions.
15. Heparin treatment received within the past 24 hours.
16. For patients on oral anticoagulants: INR \> 1.7 or PT \> 15 seconds.
17. Use of direct thrombin inhibitors or direct Factor Xa inhibitors within the past 48 hours.
18. Blood glucose \< 2.8 mmol/L or \> 22.2 mmol/L.
19. Hypodensity affecting \> 1/3 of the middle cerebral artery territory or an equivalent proportion of the basilar artery territory on non-contrast CT.
20. Rapidly improving symptoms as determined by the investigator.
21. Participation as a subject in another research study within the past 30 days.
22. Any terminal illness where life expectancy is considered not to exceed 1 year.
23. Any condition where, in the judgment of the investigator, the study treatment might pose a risk to the patient or affect the patient's participation in the study.
24. Pregnant women.
25. Known allergy to the active ingredients (Alteplase, Tenecteplase) or any excipients.
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

Other Identifiers

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[2024]288-001

Identifier Type: -

Identifier Source: org_study_id