Tenecteplase versus alteplase before mechanical thrombectomy for acute large-vessel ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

TNK-LVO is a phase III, multicenter, prospective, randomized, open-label, blinded-endpoint trial comparing intravenous tenecteplase (0.25 mg/kg) versus intravenous alteplase (0.9 mg/kg), each followed by mechanical thrombectomy for acute large-vessel occlusion stroke within 4.5 hours of last known well. Patients are randomized 1:1 at participating hospitals after imaging confirmation of occlusion in the ICA, M1/M2, ACA, PCA, or basilar artery and must have a prestroke mRS ≤2. The primary endpoint is functional independence (modified Rankin Scale ≤2) at 90 days, with blinded outcome adjudication. Safety monitoring includes imaging and hemorrhage assessments and protocol guidance to minimize delays to puncture and thrombectomy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age is ≥18 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 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).
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.

Where it's running

• Xuanwu Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Xiuhai Guo, MD — Xuanwu Hospital, Beijing
• Study coordinator: Lu Wang, MD
• Email: wanglu3261999@163.com
• Phone: 13161090533

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Effectiveness of a new neurorehabilitation technology for stroke recovery

  This study is testing a new rehabilitation technology that uses robots and virtual reality to see if it can help stroke patients recover better than regular therapy.

  Recruiting Neurotechnika · Samara, Samara Oblast · NCT06753006

• HR-MRI–Directed Tirofiban Therapy for Late-Window ICAS-LAA Stroke

  We’re testing whether tirofiban plus dual antiplatelet therapy, guided by high-resolution MRI of the brain’s blood vessels, can help people with intracranial large-artery atherosclerosis strokes that begin more than 24 hours after onset.

  Recruiting Phase 3 Weifang Medical University · Weifang, China/Shandong Province · NCT07379190

• Emergency Stroke Unit for treating acute strokes

  This study is testing a new Emergency Stroke Unit that uses a mobile MRI to see if it can help treat stroke patients faster and improve their recovery.

  Recruiting Chinese University of Hong Kong · Hong Kong · NCT06728592

• Carotid artery stenting during treatment of acute stroke

  This study is testing if adding carotid artery stenting during a stroke treatment can help improve blood flow to the brain and lower the chances of having another stroke for patients with blocked carotid arteries.

  Recruiting Phase 3 University Medical Center Groningen · Groningen · NCT06511089

• Monitoring brain-derived tau levels in acute ischemic stroke patients

  This study is testing how brain-derived tau levels change in stroke patients over 48 hours to see if it can help understand their condition and improve treatment decisions.

  Recruiting Ludwig-Maximilians - University of Munich · Munich, Bavaria · NCT06121336

• Using the Atalante exoskeleton to help stroke patients walk again

  This study is testing if using the Atalante exoskeleton can help stroke patients walk better compared to regular therapy.

  Recruiting at 4 sites Wandercraft · Créteil and 4 other locations · NCT06107010

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.