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NCT06658197RecruitingPhase 3

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

Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusive Stroke(TNK-LVO) :a Phase 3, Multicentre, Open-label, Randomised Controlled Trial

Source: ClinicalTrials.gov · Last updated 9 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
850 (estimated)
First submitted
23 Oct 2024
Start date
25 Dec 2025
Primary completion date
1 Dec 2026
Lead sponsor
Xuanwu Hospital, Beijing
Diseases
Stroke
NCT number
NCT06658197

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 850
  • From 25 Dec 2025 to the primary completion date, 1 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Intracranial or intraspinal surgery within the past 3 months.
  • Major surgery within the past 2 weeks.
  • Heparin treatment received within the past 24 hours.
  • Use of direct thrombin inhibitors or direct Factor Xa inhibitors within the past 48 hours.

Other illness

  • Patients diagnosed with hemorrhagic stroke (including intraparenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.) or other related conditions identified by CT.
  • History of intracranial hemorrhage.
  • History of severe head trauma or stroke within the past 3 months.
  • Gastrointestinal or urinary tract bleeding within the past 3 weeks.
  • Active visceral bleeding.
  • Uncontrolled hypertension despite active antihypertensive treatment: Systolic Blood Pressure \> 180 mmHg or Diastolic Blood Pressure \> 100 mmHg.
  • 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.
  • Known allergy to the active ingredients (Alteplase, Tenecteplase) or any excipients.

Lab values

  • Acute hemorrhagic tendency, including platelet count \< 100 × 10⁹/L or other conditions.
  • For patients on oral anticoagulants: INR \> 1.7 or PT \> 15 seconds.
  • Blood glucose \< 2.8 mmol/L or \> 22.2 mmol/L.

Other

  • Contraindication to imaging examinations involving contrast agent injection.
  • Patients presenting with clinical symptoms of coma (NIHSS Score Item 1a = 3).
  • Intracranial tumor, arteriovenous malformation, or giant intracranial aneurysm.
  • Aortic arch dissection.
  • Arterial puncture at a non-compressible site within the past week.
  • 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.
  • Pregnant women.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Xuanwu Hospital, Capital Medical University
Coordinator of this site? Confirm its status
BeijingChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.