Intravenous Thrombolysis With rhTNK-tPA for Acute Non-large Vessel Occlusion in Extended Time Window (NCT05752916) | Clinical Trial Compass
CompletedPhase 4
Intravenous Thrombolysis With rhTNK-tPA for Acute Non-large Vessel Occlusion in Extended Time Window
China570 participantsStarted 2023-06-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 o…