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

Launched by XUANWU HOSPITAL, BEIJING · Mar 1, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called intravenous rhTNK-tPA for patients who have suffered an acute ischemic stroke, specifically those whose symptoms started between 4.5 and 24 hours ago. The goal is to see if this treatment is effective for patients with a certain type of stroke that does not involve large blood vessels. If someone is eligible, they will have had a stroke that is disabling but not too severe, and they will need to provide consent to participate in the study.

To be eligible for this trial, participants must be at least 18 years old and have had a stroke that meets specific criteria, including a certain level of disability at the time of evaluation. They cannot have had certain recent treatments or medical conditions that would make the study unsafe for them. Participants will receive the study treatment and will be closely monitored for any effects. This trial is currently recruiting, and it offers hope for new options in treating strokes that occur within the extended time frame after symptoms begin.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Clinical diagnosis of acute ischemic stroke
• • Age≥18 years
• • Pre-stroke mRS score≤1 points
• * Disabling stroke defined as follows:
• • Baseline NIHSS score 6-25 at the time of randomization,
• • Or NIHSS 4-5 with disabling deficit (e.g. hemianopia, aphasia, loss of hand function) as determined by the managing clinician
• • Onset (last-seen-well) time to treatment time between 4.5 and 24 hours
• • Written informed consent from patients or legally responsible representatives
• • 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:
• • Treatment with a thrombolytic within the last 72 hours or intention to receive intravenous thrombolysis
• • Contraindication to thrombolysis
• • Planned or anticipated treatment with endovascular therapy
• • 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
• • Pregnancy or lactating; formal testing needed in women of childbearing potential
• • Brain tumor (with mass effect)
• • Hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
• • Impairment in coagulation due to comorbid disease or anticoagulant use. If on warfarin, international normalized ratio (INR) \>1.7 or prothrombin time \>15s; if use of any direct oral anticoagulant within the last 48 hours; if use of heparin/heparinoid within the last 24 hours
• • Use of glycoprotein Ⅱb-Ⅲa inhibitors within the last 72 hours
• • Baseline platelet count \<100,000/μL
• • Undergoing hemodialysis or peritoneal dialysis; known severe renal insufficiency with glomerular filtration rate \<30ml/min or serum creatinine \>220mmol/L (2.5mg/dl)
• • Suspected aortic dissection
• • Major surgery or biopsy within the last 1 month
• • Any active bleeding within the previous 1 month (including gastrointestinal or urinary bleeding)
• • Known severe, life-threatening allergy (more severe than skin rash) to contrast agents
• • Severe, uncontrolled hypertension (systolic blood pressure \>185mmHg or diastolic blood pressure \>110mmHg)
• • Any terminal illness such that the patient would not be expected to survive more than half a year
• • Current participation in any investigational study that may confound outcome assessment of the study
• • Any condition that, in the judgement of the investigator, is inappropriate for participation in the trial or could impose hazards to the patient (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
• • Acute large vessel occlusion on magnetic resonance/ computed tomography angiography, including internal carotid artery (ICA), middle cerebral artery M1 segment (MCA-M1）, vertebral artery and basilar artery