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

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Huashan Hospital
• Collaborators: Shanghai 10th People's Hospital; Shanghai 5th People's Hospital; Shanghai 6th People's Hospital; Shanghai East Hospital; ShuGuang Hospital
• Treatments: Tenecteplase

Criteria

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

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