Intravenous Thrombolysis With rhTNK-tPA for Acute Non-large Vessel Occlusion in Extended Time Window

• Status: Not yet recruiting
• Trial end date: 2024-12-30
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to evaluate the efficacy of IV rhTNK-tPA between 4.5 to 24 hours from symptom onset in patients presenting with a non-large vessel occlusion ischemic stroke.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xuanwu Hospital, Beijing
• Collaborator: Guangzhou Recomgen Biotech Co., Ltd.
• Treatments: Clopidogrel; Platelet Aggregation Inhibitors

Criteria

Inclusion Criteria:

• The clinical diagnosis is acute ischemic stroke (the criteria followed the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018).

• Age≥18 years

• Pre-stroke mRS score≤1 points

• Baseline NIHSS 4-25 (both included) at the time of randomization

• Onset (last-seen-well) time to treatment time between 4.5 and 24 hours

• Informed consent from the patient or surrogate

• The presence of a Target Mismatch on CT perfusion: ischemic core volume<50ml (defined as rCBF<30%), mismatch ratio≥1.2 (Tmax>6 sec lesion/core volume lesion), mismatch volume≥10ml

Exclusion Criteria:

• Treated with intravenous thrombolysis within 72 hours

• Have a clear contraindication for intravenous thrombolysis

• Intended to proceed endovascular treatment

• Rapidly improving symptoms, particularly if in the judgment of the managing clinician that the improvement is likely to result in a NIHSS score<4 at randomization

• Woman of childbearing potential who is known to be pregnant or who has a positive pregnancy test on admission

• Brain tumor (with mass effect)

• Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency

• Coagulation Disorders caused by diseases or anticoagulants: warfarin was used with International Normalized Ratio (INR)>1.7 or PT>15s; heparin was administered within 24 hours; novel oral anticoagulants were used within 48 hours

• Glycoprotein IIb-IIIa inhibitors were used within the past 72 hours

• Baseline platelet count <100×109/L

• Known severe renal insufficiency with eGFR<30ml/min or serum creatinine>2.5mg/dl

• Undergoing hemodialysis or peritoneal dialysis; known severe intolerance to contrast media

• Suspected aortic dissection

• Parenchymal organ surgery or biopsy within the previous 1 month

• Any active bleeding within the previous 1 month (including gastrointestinal or urinary bleeding)

• Known severe allergy (more than a rash) to contrast media uncontrolled by medications

• Refractory hypertension (defined as persistent systolic blood pressure>185mmHg or diastolic blood pressure>110mmHg)

• Expected survival time<0.5 year (such as complicated with malignant tumor, serious heart and lung diseases, etc.)

• Participants in other interventional randomized trials that may confound the outcome assessment

• Other circumstances that the investigator considers inappropriate for participation in the trial or that may pose significant risks to patients (e.g., inability to understand and/or follow the study procedures and/or follow up due to mental disorders, cognitive or emotional disorders)

Specific Neuroimaging Exclusion Criteria:

• Evidence of acute intracranial hemorrhage

• Presence of proximal arterial occlusion on CTA/MRA (e.g., intracranial ICA, MCA-M1 and dominant M2 segments, and vertebrobasilar arteries)

• Ischemic core volume>1/3 of the MCA territory defined on CT/MRI