Overview

MRI-guided thrOmbolysis for Stroke bEyond Time Window by TNK

Status:
Recruiting
Trial end date:
2022-07-01
Target enrollment:
0
Participant gender:
All
Summary
This is an open label multicentre trial, evaluating the utility of MRI-guided thrombolysis for stroke beyond time window by Tenecteplase (TNK-tPA). This exploratory study was to describe the feasibility and outcome of thrombolytic therapy with TNK-tPA in 4.5-24 hours after stroke guided by a mismatch between diffusion-weighted imaging and FLAIR in the region of ischemia.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
General Hospital of Shenyang Military Region
Treatments:
Tenecteplase
Criteria
Inclusion Criteria:

1. Patient age 18-80 years;

2. The time from onset to treatment: 4.5-24 hours;

3. Acute Ischemic stroke confirmed by MRI;

4. NIHSS score ：6-25, or NIHSS score≤ 5 but culprit vessel occlusion or severe stenosis (
ICA, MCA-M1/M2, ACA) on CTA/MRA;

5. Imaging requirements: (1) DWI infarct region: no more than 1/3 of middle cerebral
artery territory or 1/2 of the anterior cerebral artery territory or 1/2 of the
posterior cerebral artery territory; (2) DWI infarct volume <70 ml; (2) presence of
DWI/Flair mismatch: DWI high signal and Flair visually normal;

6. the first onset of ischemic stroke or previous stroke with no obvious sequelae
(mRS≤1);

7. Signed informed consent

Exclusion Criteria:

1. Planned endovascular treatment;

2. Serious neurological deficits before onset ( mRS ≥ 2);

3. Obvious head injuries or strokes within 3 months;

4. Subarachnoid hemorrhage;

5. History of intracranial hemorrhage;

6. Intracranial tumor, arteriovenous malformation or aneurysm;

7. Intracranial or spinal cord surgery within 3 months;

8. Arterial puncture at a noncompressible site within the previous seven days;

9. Active internal hemorrhage;

10. coagulation abnormalities: platelet count of <100000/mm3 ；

11. Aortic arch dissection；

12. Heparin therapy within 24 hours;

13. Infective endocarditis；

14. Oral warfarin is being taken and INR>1.6 or APTT abnormal；

15. oral anticoagulation therapy；

16. Systolic pressure ≥185 mmHg or diastolic pressure ≥110 mmHg；

17. Blood glucose < 50 mg/dl (2.7mmol/L)；

18. Pregnancy;

19. Neurological deficit after epileptic seizures;

20. Major surgery within 1 month;

21. Gastrointestinal or urinary tract hemorrhage within the previous 30 days;

22. Myocardial infarction within 3 months;

23. allergy to study drugs;

24. Contradictory to MRI examination；

25. MRI image not qualified for evaluation；

26. Other serious illness；

27. Participating in other clinical trials within 3 months;

28. patients not suitable for this clinical studies considered by researcher.