NCT06658197 Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke
| NCT ID | NCT06658197 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Xuanwu Hospital, Beijing |
| Condition | Stroke, Ischemic |
| Study Type | INTERVENTIONAL |
| Enrollment | 850 participants |
| Start Date | 2025-12-25 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 850 participants in total. It began in 2025-12-25 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Xiuhai Guo, MD
PRINCIPAL INVESTIGATOR
Xuanwu Hospital, Beijing
Frequently Asked Questions
Who can join the NCT06658197 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke, Ischemic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06658197 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 850 participants.
Is NCT06658197 currently recruiting?
Yes, NCT06658197 is actively recruiting participants. Contact the research team at wanglu3261999@163.com for enrollment information.
Where is the NCT06658197 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06658197 clinical trial?
NCT06658197 is sponsored by Xuanwu Hospital, Beijing. The principal investigator is Xiuhai Guo, MD at Xuanwu Hospital, Beijing. The trial plans to enroll 850 participants.
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