Additive Effects of Intra-arterial Tenecteplase for Successful Thrombectomy Due to Acute Basilar Artery Occlusion

Launched by FIRST HOSPITAL OF CHINA MEDICAL UNIVERSITY · Oct 12, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a treatment for patients who have experienced a blockage in the basilar artery, which can lead to serious neurological problems. Researchers want to see if adding a medication called tenecteplase, given through the artery after a procedure to remove the blockage (called thrombectomy), can help improve recovery outcomes for these patients. Previous studies suggest that while many patients may have successful procedures, they still struggle with daily activities afterward. This trial aims to find out if the additional use of tenecteplase can enhance recovery even further.

To participate in this trial, patients need to be between 18 and 80 years old and have a confirmed blockage in the basilar artery, along with certain other health criteria. They should have a moderate level of neurological symptoms before the procedure. Participants will receive either the tenecteplase treatment or a placebo (a non-active substance) after their thrombectomy. Throughout the study, researchers will closely monitor participants to assess their recovery over the next three months. It’s important to note that this trial is not yet recruiting participants, but it aims to provide valuable insights into improving treatment for this serious condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 - 80 yro；
• • 2. Acute symptomatic basilar artery occlusion identified by neuroimaging modalities (CTA/MRA/DSA)；
• • 3. NIHSS ≥ 6 before thrombectomy；
• • 4. Time from symptom onset (or last seen normal) to arterial TNK/placebo is less than 24 hours；
• • 5. pc-ASPECTS ≥ 6 and Pons-midbrain-index ≤ 2
• • 6. Successful recanalization（eTICI 2b-3）at the end of procedure（The maximum will be six passes or six aspirations for the patient）；Patients with an eTICI score 2b/3 on the diagnostic cerebral angiography before the onset of MT are also eligible for the study.
• • 7. Exclusion of parenchymal hemorrhagic transformation (DynaCT/XpertCT) before intra-arterial agent administration；
• • 8. Pre-morbid mRS ≤ 1；
• • 9. Patient or legal proxy is able to understand and willing to provide written inform and consent.
• Exclusion Criteria:
• • 1. Patient received thrombolysis prior to EVT
• • 2. NIHSS score on admission \>25
• • 3. Contraindication to IA TNK as per local national guidelines (except time to therapy)
• • 4. Use of stents during the endovascular procedure requiring dual antiplatelet therapy during the first 24h
• • 5. Female who is pregnant or lactating or has a positive pregnancy test at time of admission
• • 6. Current participation in another investigation drug or device treatment study (except observational study)
• • 7. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
• • 8. Known coagulopathy, INR \>1.7 or use of novel anticoagulants \< 48h from symptom onset
• • 9. Platelets \<100,000
• • 10. Renal Failure as defined by a serum creatinine \>3.0 mg/dl (or 265.2 μmol/l) or glomerular Filtration Rate \[GFR\] \<30.
• • 11. Subject who requires hemodialysis or peritoneal dialysis, or who have a contraindication to an angiogram for whatever reason
• • 12. Any hemorrhage on CT/MRI
• • 13. Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal
• • 14. Suspicion of aortic dissection
• • 15. Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol
• • 16. History of life threatening allergy (more than rash) to TNK or contrast medium
• • 17. SBP \>185 mmHg or DBP \>110 mmHg refractory to treatment
• • 18. Serious, advanced, terminal illness with anticipated life expectancy \<6 months
• • 19. Pre-existing neurological or psychiatric disease that would confound evaluation
• • 20. Presumed vasculitis or septic embolization
• • 21. Unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitor from overseas)
• • 22. Other conditions at investigators' discretion which are not appropriate for participation.