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

Launched by XUANWU HOSPITAL, BEIJING · Oct 23, 2024

Keywords

ClinConnect Summary

This clinical trial is designed to compare two treatments for patients who have experienced an acute large vessel occlusion stroke, which is a type of stroke caused by a blockage in a major blood vessel in the brain. The researchers want to find out if using a drug called tenecteplase, along with a procedure to remove the blockage (mechanical thrombectomy), is more effective than using another drug called alteplase with the same procedure. The trial will include adults aged 18 to 80 who have had stroke symptoms for less than 4.5 hours and meet specific health criteria.

If you or a loved one are considering participating in this trial, it's important to know that certain conditions must be met. For example, participants should not have had a prior brain bleed or major surgery recently, and they should be able to give informed consent. The trial is not yet recruiting participants, but if selected, individuals can expect to receive either of the two treatments while being closely monitored for safety and effectiveness. This study aims to provide valuable information that could improve treatment options for stroke patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age is 18-80 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 on CTA of the ICA, ACA, PCA, M1, M2 or basilar.
• • 4. Prestroke mRS score ≤2.
• • 5. Informed consent from the patient or legally authorised representative.
• Exclusion Criteria:
• • 1. ICH, subarachnoid haemorrhage or other brain haemorrhage identified by CT.
• • 2. NIHSS consciousness score (NIHSS 1a) \>2.
• • 3. Contraindication to imaging with contrast agents.
• • 4. Intraventricular haemorrhage, subarachnoid haemorrhage, subdural/external haematoma, etc) in previous 3 months.
• • 5. Severe brain trauma or ischaemic stroke in previous 3 months.
• • 6. Intracranial or intraspinal surgery in previous 3 months.
• • 7. Major surgery within the previous 14 days.
• • 8. Gastrointestinal or urinary tract haemorrhage within the previous 21 days.
• • 9. Known malignant intracranial neoplasm, giant intracranial aneurysm or arteriovenous malformation.
• • 10. Known active visceral bleeding.
• • 11. Known aortic arch dissection.
• • 12. Arterial puncture at a non-compressible site within the previous 7 days.
• • 13. Persistent blood pressure elevation (systolic ≥180 mm Hg or diastolic ≥100 mm Hg), despite blood pressure lowering treatment.
• • 14. Known defect of platelet or clotting function, platelet count below 100×109/L (note that patients on antiplatelet agents can be included).
• • 15. Use of heparins during the last 48 hours.
• • 16. Any known defect in coagulation, for example, current use of oral warfarin anticoagulant with an international normalised ratio \>1.7 or prothrombin time \>15 s.
• • 17. Use of direct thrombin inhibitors or direct factor Xa inhibitors during the last 48 hours.
• • 18. Blood glucose \<2.8 mmol/L or \>22.22 mmol/L (point-of-care glucose testing is acceptable).
• • 19. Hypodensity in \>1/3 middle cerebral artery territory on non-contrast computer tomography (NCCT).
• • 20. Rapidly improving symptoms at the discretion of the investigator.
• • 21. Participation in another clinical trial within the previous 3 months.
• • 22. Any terminal illness such that patient would not be expected to survive \>1 year.