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

Recruiting now · Phase 3

Conditions studied: Stroke, Ischemic, Stroke, Acute, Thrombosis, Brain, Drug Effect

In brief

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.

Key facts

Study ID

NCT06658197

Run by

Xuanwu Hospital, Beijing

People needed

850

Starts

2025-12-25

Expected to finish

2027-06-01

Last updated by the study team

2026-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• For patients on oral anticoagulants: INR > 1.7 or PT > 15 seconds.
• Use of direct thrombin inhibitors or direct Factor Xa inhibitors within the past 48 hours.
• Blood glucose < 2.8 mmol/L or > 22.2 mmol/L.
• Hypodensity affecting > 1/3 of the middle cerebral artery territory or an equivalent proportion of the basilar artery territory on non-contrast CT.
• Rapidly improving symptoms as determined by the investigator.
• Participation as a subject in another research study within the past 30 days.
• Any terminal illness where life expectancy is considered not to exceed 1 year.
• 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.
• Pregnant women.
• Known allergy to the active ingredients (Alteplase, Tenecteplase) or any excipients.

Where it is running

• Xuanwu Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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