Acute Ischemic Stroke Clinical Trial
— OPTIONOfficial title:
Intravenous Thrombolysis With Recombinant Human TNK Tissue-type Plasminogen Activator (rhTNK-tPA) for Acute Non-large Vessel Occlusion in Extended Time Window--A Multicenter, Prospective, Randomized, Open-label, Blinded End-point Trial
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.
Status | Recruiting |
Enrollment | 568 |
Est. completion date | December 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Xuanwu Hospital, Capital Medical University | Beijing |
Lead Sponsor | Collaborator |
---|---|
Xuanwu Hospital, Beijing | Guangzhou Recomgen Biotech Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Incidence of any intracranial hemorrhage | Incidence of any intracranial hemorrhage (Heidelberg criteria) measured at 36 hours | 36 hours | |
Other | Incidence of clinically significant intracranial hemorrhage | Incidence of sICH (Heidelberg criteria) measured at 36 hours | 36 hours | |
Other | Incidence of major bleeding | Incidence of major bleeding defined as GUSTO severe/life threatening or moderate bleeds measured at 90±7 days | 90±7 days | |
Other | All-cause mortality | All-cause mortality at 90±7 days | 90±7 days | |
Primary | Excellent functional outcome | Proportion of subjects with mRS 0-1 at 90±7 days | 90±7 days | |
Secondary | modified Rankin Scale (mRS) score | Ordinal distribution of mRS at 90±7 days; modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death) | 90±7 days | |
Secondary | Good functional outcome | Proportion of subjects with mRS 0-2 at 90±7 days | 90±7 days | |
Secondary | Rate of successful reperfusion | >90% reduction of the Tmax>6s lesion volumes between the baseline and early follow-up at 24 hours (-2/+12 hours) | 24 hours (-2/+12 hours) | |
Secondary | Change of infarct volume from baseline to 24 hours (-2/+12 hours) | The infarct volume is determined on evaluated on CT at 24 hours (-2/+12 hours) | 24 hours (-2/+12 hours) | |
Secondary | Early clinical recovery | Proportion of subjects with NIHSS score=8 improved compared with baseline or with NIHSS 0-1 at 24 hours (-2/+12 hours) | 24 hours (-2/+12 hours) | |
Secondary | Change of National Institutes of Health Stroke Scale (NIHSS) | Change of NIHSS score from baseline to 7 days (±2days) | 7±2 days |
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