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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06221371
Other study ID # CSA2023YJ003
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date December 16, 2023
Est. completion date May 2025

Study information

Verified date May 2024
Source Beijing Tiantan Hospital
Contact Yunyun Xiong, MD
Phone 15710088948
Email xiongyunyun@bjtth.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the safety and efficacy of endovascular treatment with or without preceding intravenous Tenecteplase in patients with late-window (4.5-24 hours of symptom onset) acute ischemic stroke due to middle cerebral artery (MCA) M1 or M2 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 390
Est. completion date May 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
rhTNK-tPA
rhTNK-tPA (0.25 mg/kg, maximum dose 25mg) is given as a single, intravenous bolus (injection over 5 to 10 seconds) immediately upon randomization. EVT should be performed as soon as possible after rhTNK-tPA administration.
Device:
direct EVT
During the study period, NMPA-approved stents are permitted. EVT included thrombectomy with stent retrievers, thromboaspiration, intraarterial thrombolysis, balloon angioplasty, stenting, or a combination of these approaches at the discretion of the interventional team.

Locations

Country Name City State
China Beijing Tiantan Hospital, Capital Medical University Beijing Beijing
China Heze Municipal Hospital Heze Shandong
China Liaocheng Third People's Hospital Liaocheng Shandong
China Linfen Central Hospital Linfen Shanxi
China Linyi People's Hospital Linyi Shandong
China Eastern Theater General Hospital Nanjing Jiangsu
China Qingdao Central Hospital Qingdao Shandong
China Rizhao People's Hospital Rizhao Shandong
China Rizhao Traditional Chinese Medicine Hospital Rizhao Shandong
China First Affiliated Hospital of Xi 'an Jiaotong University Xi'an Shaanxi

Sponsors (2)

Lead Sponsor Collaborator
Beijing Tiantan Hospital Linyi People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The modified Rankin Scale score (mRS) 0 to 2 at 90 days The proportion of the modified Rankin Scale score (mRS) 0 to 2 at 90 days 90 days
Secondary mRS at 90 days (shift analysis) Ordinal distribution of mRS at 90 days 90 days
Secondary mRS 0-1 at 90 days The proportion of mRS 0 - 1 at 90 days 90 days
Secondary mRS 0-3 at 90 days The proportion of mRS 0 - 3 at 90 days 90 days
Secondary mRS 5-6 at 90 days The proportion of mRS 5 - 6 at 90 days 90 days
Secondary NIHSS=1 or a decrease of 8 points or more from baseline at 72h after randomization NIHSS=1 or a decrease of 8 points or more from baseline at 72h after randomization 72 hours
Secondary Change of stroke severity at 7 days after randomization from baseline Change of stroke severity (NIHSS score) at 7 days after randomization from baseline 7 days
Secondary Successful recanalization prior to EVT by DSA Successful recanalization prior to EVT by DSA (defined as eTICI score of 2b50-3) 0 hours (at treatment time)
Secondary Complete recanalization according to CTA or MRA performed 24 hours after randomization Complete recanalization according to CTA or MRA performed 24 hours after randomization (AoL recanalization score) 24 hours
Secondary Good reperfusion at 24h after randomization Good reperfusion at 24h after randomization (Tmax>6s improved by 90% compared with before) 24 hours