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

NCT06658197 | Recruiting Phase 3 DMC

• 1 other identifier: [2024]288-001
• Study Type: interventional
• Target: 850
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic; Stroke, Acute; Thrombosis, Brain; Drug Effect

Keywords

Ischemic stroke; Tenecteplase

Outcome Measures

Primary Outcomes (1)

• mRS ≤ 2 at 90 days or no change from baseline

  mRS ≤ 2 at 90 days or no change from baseline

  90 days from baseline

Secondary Outcomes (6)

• 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

Other Outcomes (4)

• sICH within 36 hours from baseline

  36 hours from baseline

• Vascular death within 90 days from baseline

  Within 90 days from baseline

• Death from any cause within 90 days from baseline

  Within 90 days from baseline

Study Arms (2)

tenecteplase

EXPERIMENTAL

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

Drug: Tenecteplase

alteplase

ACTIVE COMPARATOR

Subjects assigned to this arm will receive an intravenous 0.9 mg/kg alteplase(10% bolus +90% infusion/1 hour) before the mechanical thrombectomy.

Drug: Alteplase

Interventions

Tenecteplase DRUG

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

Also known as: TNK

tenecteplase

Alteplase DRUG

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

Also known as: recombinant tissue plasminogen activator (rtPA)

alteplase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≤2.
• Informed consent from the patient or legally authorised representative.

You may not qualify if:

• 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.
• Aortic arch dissection.
• Arterial puncture at a non-compressible site within the past week.
• Uncontrolled hypertension despite active antihypertensive treatment: Systolic Blood Pressure \> 180 mmHg or Diastolic Blood Pressure \> 100 mmHg.
• Acute hemorrhagic tendency, including platelet count \< 100 × 10⁹/L or other conditions.
• Heparin treatment received within the past 24 hours.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Intracranial Thrombosis

Interventions

Tenecteplase; Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Embolism and Thrombosis; Thromboembolism; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Officials

• Xiuhai Guo, MD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lu Wang, MD

CONTACT

13161090533; wanglu3261999@163.com

Xiuhai Guo, MD

CONTACT

18810285127; guoxhxuan@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 26, 2024
• Study Start: December 25, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)