CHinese Acute Tissue-Based Imaging Selection for Lysis In Stroke -Tenecteplase II

Huashan Hospital224 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

224

Conditions

Stroke

Interventions

TenecteplaseDRUG

Intravenous (IV) tenecteplase 0.25 mg/kg (single bolus; maximum dose 25 mg)

The best treatment selected by local doctors(Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy)DRUG

Best treatment arm

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients presenting with anterior circulation acute ischaemic stroke 2. Time from onset to treatment 4.5h-24h 3. Patient's age is \>= 18 years，\<= 80 4. Pre-stroke mRS score of \<= 2 5. Clinically significant acute neurologic deficit 6. Baseline National Institute of Health stroke scale \>= 6 7. Vessel occlusion or severe stenosis ( ICA, MCA-M1/M2, ACA) on computed tomography angiography (CTA)/MRA 8. 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 9. Informed consent was obtained from patients. Exclusion Criteria: 1. Intracranial hemorrhage or subarachnoid hemorrhage identified by CT or MRI 2. Rapidly improving symptoms (patient with an NIHSS score decrease to \< 4 at randomization) 3. Pre-stroke mRS score of \> 2 4. Contraindication to imaging with CT/magnetic resonance imaging with contrast agents 5. Infarct core \>1/3 middle cerebral artery (MCA) territory 6. Platelet count \< 100x10\^9/L 7. Symptoms were caused by low blood glucose \< 2.7 mmol/l 8. Severe uncontrolled hypertension, i.e. systolic blood pressure \>= 180 mmHg or diastolic blood pressure \>=100 mmHg 9. Current use of warfarin with a prolonged prothrombin time (INR \> 1.7 or prothrombin time \> 15s) 10. Use of low molecular weight heparin within 24 hours 11. Use of non-vitamin K antagonist oral anticoagulants (NOACs) within 48 hours 12. Use of glycoprotein IIb - IIIa inhibitors within 72 hours. 13. Arterial puncture at noncompressible site in previous 7 days 14. Major surgery in previous 14 days which poses risk in the opinion of the investigator 15. Recent gastrointestinal or urinary tract hemorrhage (within previous 21 days) 16. Significant head trauma or prior stroke in previous 3 months 17. History of previous intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation, or aneurysm. Risks were considered by the investigator 18. Hereditary or acquired haemorrhagic diathesis 19. Active internal bleeding 20. Symptoms suggestive or recent acute pancreatitis, active gastrointestinal ulcer 21. Severe liver disease, including liver failure, cirrhosis, portal hypertension and active hepatitis 22. Pregnancy or lactation 23. Various dying diseases with life expectancy ≤3 months 24. Other conditions in which doctors believe that participating in this study may be harmful to the patient 25. Patients participated in any trial in 30 days 26. Allergic to the test drug and its ingredients

Locations (1)

Huashan Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

patients without endovascular therapy obtained >50% reperfusion at 4-6 hours

Without endovascular therapy: \>50% reperfusion on computed tomography perfusion (CTP) at 4-6 hours

Time frame: 4-6 hours

patients with endovascular therapy: mTICI score 2b or better at initial angiogram

With endovascular therapy: mTICI score 2b or better at initial angiogram after thrombolysis before endovascular therapy

Time frame: Before endovascular therapy

no symptomatic intracranial hemorrhage at 24-36 hours

No symptomatic intracranial hemorrhage at 24-36 hours

Time frame: 24-36 hours

Secondary Outcomes

Imaging efficacy outcome: recanalization rate on CT/magnetic resonance angiography

Recanalization rate on CTA/MRA at 4-6 hours

Time frame: 4-6 hours

Imaging efficacy outcome: Infarct volume growth (ml) at 3-5 days on MRI or CT perfusion

Infarct volume growth (ml) at 3-5 days on MRI or CT perfusion

Time frame: 3-5 days

Clinical efficacy outcome: NIHSS change

NIHSS change at 24 hours (plus or minus 2 hours)

Time frame: 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)

percent of excellent functional outcome (modified Rankin scale 0-1) at 90 days (plus or minus 7 days)

Time frame: 90 days (plus or minus 7 days)

Data from ClinicalTrials.gov

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