CHinese Acute Tissue-Based Imaging Selection for Lysis In Stroke -Tenecteplase II
- Conditions
- Stroke
- Interventions
- Drug: The best treatment selected by local doctors(Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy)
- Registration Number
- NCT04516993
- Lead Sponsor
- Huashan Hospital
- Brief Summary
To explore the efficacy and safety of tenecteplase for acute ischemic stroke patients (onset time 4.5-24h) of large vessel occlusion using early combined CT/MR imaging outcomes
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 224
- Patients presenting with anterior circulation acute ischaemic stroke
- Time from onset to treatment 4.5h-24h
- Patient's age is >= 18 years，<= 80
- Pre-stroke mRS score of <= 2
- Clinically significant acute neurologic deficit
- Baseline National Institute of Health stroke scale >= 6
- Vessel occlusion or severe stenosis ( ICA, MCA-M1/M2, ACA) on computed tomography angiography (CTA)/MRA
- Multimodal CT/magnetic resonance imaging: perfusion lesion volume (DT > 3 s) to infarct core volume ratio (rCBF<30% or diffusion-weighted imaging lesion) >1.2, absolute difference >10 ml, and ischemic core volume <70ml
- Informed consent was obtained from patients.
- Intracranial hemorrhage or subarachnoid hemorrhage identified by CT or MRI
- Rapidly improving symptoms (patient with an NIHSS score decrease to < 4 at randomization)
- Pre-stroke mRS score of > 2
- Contraindication to imaging with CT/magnetic resonance imaging with contrast agents
- Infarct core >1/3 middle cerebral artery (MCA) territory
- Platelet count < 100x10^9/L
- Symptoms were caused by low blood glucose < 2.7 mmol/l
- Severe uncontrolled hypertension, i.e. systolic blood pressure >= 180 mmHg or diastolic blood pressure >=100 mmHg
- Current use of warfarin with a prolonged prothrombin time (INR > 1.7 or prothrombin time > 15s)
- Use of low molecular weight heparin within 24 hours
- Use of non-vitamin K antagonist oral anticoagulants (NOACs) within 48 hours
- Use of glycoprotein IIb - IIIa inhibitors within 72 hours.
- Arterial puncture at noncompressible site in previous 7 days
- Major surgery in previous 14 days which poses risk in the opinion of the investigator
- Recent gastrointestinal or urinary tract hemorrhage (within previous 21 days)
- Significant head trauma or prior stroke in previous 3 months
- History of previous intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation, or aneurysm. Risks were considered by the investigator
- Hereditary or acquired haemorrhagic diathesis
- Active internal bleeding
- Symptoms suggestive or recent acute pancreatitis, active gastrointestinal ulcer
- Severe liver disease, including liver failure, cirrhosis, portal hypertension and active hepatitis
- Pregnancy or lactation
- Various dying diseases with life expectancy ≤3 months
- Other conditions in which doctors believe that participating in this study may be harmful to the patient
- Patients participated in any trial in 30 days
- Allergic to the test drug and its ingredients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Best treatment arm (e.g. Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy) The best treatment selected by local doctors(Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy) The best treatment selected by local doctors Tenecteplase arm Tenecteplase -
- Primary Outcome Measures
Name Time Method patients without endovascular therapy obtained >50% reperfusion at 4-6 hours 4-6 hours Without endovascular therapy: \>50% reperfusion on computed tomography perfusion (CTP) at 4-6 hours
patients with endovascular therapy: mTICI score 2b or better at initial angiogram Before endovascular therapy With endovascular therapy: mTICI score 2b or better at initial angiogram after thrombolysis before endovascular therapy
no symptomatic intracranial hemorrhage at 24-36 hours 24-36 hours No symptomatic intracranial hemorrhage at 24-36 hours
- Secondary Outcome Measures
Name Time Method Clinical safety outcome: Rate of systemic bleeding 90 days (plus or minus 7 days) Rate of systemic bleeding within 90 days (plus or minus 7 days)
Imaging safety outcome: Intracranial hemorrhage of any volume at 24-36 hours 24-36 hours Intracranial hemorrhage of any volume at 24-36 hours
Imaging safety outcome: parenchymal hematoma 2 at 24-36 hours 24-36 hours Parenchymal hematoma 2 at 24-36 hours
Imaging safety outcome: Symptomatic intracranial hemorrhage at 24-36 hours 24-36 hours Symptomatic intracranial hemorrhage at 24-36 hours
Clinical safety outcome: death within 90 days 90 days (plus or minus 7 days) Death within 90 days (plus or minus 7 days)
Imaging efficacy outcome: recanalization rate on CT/magnetic resonance angiography 4-6 hours Recanalization rate on CTA/MRA at 4-6 hours
Imaging efficacy outcome: Infarct volume growth (ml) at 3-5 days on MRI or CT perfusion 3-5 days Infarct volume growth (ml) at 3-5 days on MRI or CT perfusion
Clinical efficacy outcome: percent of good functional outcome (modified Rankin scale 0-2) at 90 days (plus or minus 7 days) 90 days (plus or minus 7 days) percent of good functional outcome (modified Rankin scale 0-2) at 90 days (plus or minus 7 days)
Clinical efficacy outcome: incident event 90 days (plus or minus 7 days) Incident vascular event within 90 days (ischemic stroke/ hemorrhagic stroke/ cardiac infarct/ cardiac or brain revascularization (including Carotid Endarterectomy, Intracranial and Extracranial Artery Intervention, Intracranial and extracranial artery bypass, and Coronary artery intervention or bypass graft))
Clinical efficacy outcome: NIHSS change 24 hours (plus or minus 2 hours) NIHSS change at 24 hours (plus or minus 2 hours)
Clinical efficacy outcome: percent of excellent functional outcome (modified Rankin scale 0-1) at 90 days (plus or minus 7 days) 90 days (plus or minus 7 days) percent of excellent functional outcome (modified Rankin scale 0-1) at 90 days (plus or minus 7 days)
Clinical efficacy outcome: NIHSS change at 7 days 7 days (plus or minus 2 days) NIHSS change at 7 days (plus or minus 2 days)
Barthel index 90 days (plus or minus 7 days) Barthel index at 90 days (plus or minus 7 days). The Barthel Index is a scale that indicates the ability to perform a selection of activities of daily living. It comprises 10 items (tasks), with total scores ranging from 0 (worst mobility in activities of daily living) to 100 (full mobility in activities of daily living) and it has adequate clinimetric (quality of clinical measurements) properties in stroke rehabilitation. In the index, the 10 items have these scoring combinations: a) 0 and 5, b) 0, 5 and 10, or c) 0, 5, 10 and 15. These items in the Barthel Index address a patient's ability in feeding, bathing, grooming, dressing, bowel and bladder control, toileting, chair transfer, ambulation and stair climbing.
Imaging efficacy outcome: patients without endovascular therapy obtained >50% reperfusion at 4-6 hours 4-6 hours Without endovascular therapy: \>50% reperfusion on computed tomography perfusion (CTP) at 4-6 hours without Parenchymal hematoma 2
Imaging efficacy outcome: patients with endovascular therapy: mTICI score 2b or better at initial angiogram Before endovascular therapy With endovascular therapy: mTICI score 2b or better at initial angiogram after thrombolysis before endovascular therapy Parenchymal hematoma 2
Imaging efficacy outcome: recanalization rate on CT/magnetic resonance angiography at 3-5 days 3-5 days Recanalization rate on CTA/MRA at 3-5 days
Clinical efficacy outcome: vascular death within 90 days 90 days (plus or minus 7 days) Vascular death within 90 days (plus or minus 7 days) (stroke, cardiac infarct, pulmonary embolism)
Clinical efficacy outcome: major neurological improvement at 24-36 hours ( NIHSS reduction ≥8 or return to 0-1)major neurological improvement at 24-36 hours ( NIHSS reduction ≥8 or return to 0-1) 24-36 hours Major neurological improvement at 24-36 hours ( NIHSS reduction \>8 or return to 0-1)
Trial Locations
- Locations (1)
Huashan Hospital
🇨🇳Shanghai, Shanghai, China