Search / Trial NCT06221371

Endovascular Treatment With or Without Preceding Intravenous Tenecteplase (TNK) in Patients With Late-window acUte Ischemic Stroke Due to Middle Cerebral Artery Occlusion

Launched by BEIJING TIANTAN HOSPITAL · Jan 15, 2024

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Trial Information

Current as of October 08, 2024

Recruiting

Keywords

Endovascular Treatment Thrombolysis Tenecteplase Middle Cerebral Artery Occlusion

Description

After being informed about the study and potential risks, patients who meet the inclusion criteria will be randomized to endovascular treatment with preceding intravenous rhTNK-tPA (0.25mg/kg, maximum 25mg) or without preceding intravenous rhTNK-tPA in a 1:1 ratio. Written informed consent will be needed.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Age≥18 years old.
  • 2. Acute ischemic stroke symptom onset between 4.5 to 24 hours prior to enrollment including wake-up stroke and unwitnessed stroke; Onset time refers to 'last seen well time'.
  • 3. MCA-M1 or M2 occlusions confirmed by Computer Tomography Angiography (CTA)/Magnetic Resonance Angiography (MRA) that was responsible for signs and symptoms of acute ischemic stroke.
  • 4. Neuroimaging: target mismatch profile on CT perfusion (CTP) or MRI + perfusion weighted imaging (PWI) (analyzed by perfusion analysis software with Class II and above medical device certificates) \[ischemic core volume (defined as CBF\<30%) \<70mL, mismatch ratio≥1.8, mismatch volume≥15mL\].
  • 5. Pre-stroke mRS score ≤2.
  • 6. Baseline NIHSS 6-25 (both included).
  • 7. Written informed consent from patients or their legally authorized representative.
  • Exclusion Criteria:
  • 1. Patients who decline interventional therapy or intravenous thrombolysis (IVT).
  • 2. Patients allergic to Recombinant Human TNK Tissue-type Plasminogen Activator for Injection (rhTNK-tPA).
  • 3. Rapidly improving symptoms at the discretion of the investigators.
  • 4. NIHSS consciousness score 1a\>2, or epileptic seizure, hemiplegia after seizures or combined with other nervous/mental illness not able to cooperate or unwilling to cooperate.
  • 5. Persistent blood pressure elevation (systolic \> 185 mmHg or diastolic \> 110 mmHg), despite blood pressure lowering treatment.
  • 6. Blood glucose \< 2.8 or \> 22.2 mmol/L (on random glucose testing is acceptable).
  • 7. Active internal bleeding or at high risk of bleeding, e.g.: Major surgery, trauma or gastrointestinal or urinary tract hemorrhage within the previous 21 days, or arterial puncture at a non-compressible site within the previous 7 days.
  • 8. Any known impairment in coagulation, e.g.: If on vitamin K antagonists, then INR\>1.7 or prothrombin time \>15 seconds; if use of any direct thrombin inhibitors or new oral anticoagulants (NOACs) during the last 48 hours unless reversal of effect can be achieved with idarucizumab; values in sensitivity laboratory tests exceed the upper limit of normal \[including activated partial thromboplastin time (aPTT), international normalized ratio (INR), platelet count, thrombin time (TT), or appropriate factor Xa activity assays, etc.\]; if on heparin during the last 24 hours or with an elevated aPTT greater than the upper limit of normal.
  • 9. Known defect of platelet function or platelet count below 100\*109/L (patients on antiplatelet agents can be included).
  • 10. Ischemic stroke or myocardial infarction in previous 3 months, previous intracranial hemorrhage, severe traumatic brain injury, intracranial or intraspinal operation in previous 3 months, or known intracranial neoplasm (neuroectodermal tumor excluded like meningioma), arteriovenous malformation or giant aneurysm.
  • 11. Patients who would not be expected to survive more than 1 year.
  • 12. Unable to perform CTP or PWI.
  • 13. Large infarct on non-contrast CT brain or MRI (infarct size \>1/3 MCA territory).
  • 14. Acute or past intracerebral hemorrhage (ICH) identified by CT or MRI, including cerebral parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, and subdural/extradural hematoma.
  • 15. Multiple arterial occlusions (bilateral MCA occlusion, MCA occlusion accompanied by basilar artery occlusion).
  • 16. Pregnant women, nursing mothers, or reluctant to take contraceptive measures during the trial period.
  • 17. Unlikely to adhere to the trial protocol or follow-up.
  • 18. Any condition that, in the investigator's judgment, could pose a hazard to the patient if study therapy is initiated or could impact the patient's ability to participate in the study.
  • 19. Participation in any other interventional clinical trials within the previous 3 months.

About Beijing Tiantan Hospital

Beijing Tiantan Hospital, affiliated with Capital Medical University, is a leading medical institution in China renowned for its expertise in neurology, neurosurgery, and various other specialties. As a prominent clinical trial sponsor, the hospital is committed to advancing medical research and improving patient outcomes through innovative studies. With a focus on high-quality clinical trials, Beijing Tiantan Hospital adheres to rigorous ethical standards and regulatory requirements, fostering collaboration with academic institutions and industry partners to facilitate the development of cutting-edge therapies and interventions. Its state-of-the-art facilities and experienced research team enable the hospital to play a pivotal role in the global medical research landscape.

Locations

Linyi, Shandong, China

Beijing, Beijing, China

Qingdao, Shandong, China

Xi'an, Shaanxi, China

Nanjing, Jiangsu, China

Heze, Shandong, China

Liaocheng, Shandong, China

Rizhao, Shandong, China

Rizhao, Shandong, China

Linfen, Shanxi, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0