MRI-guided thrOmbolysis for Stroke bEyond Time Window by TNK

Stroke Clinical Trial

— ROSE-TNK  

Official title:

MRI-guided thrOmbolysis for Stroke bEyond Time Window by TNK (ROSE-TNK): a Prospective, Randomized, Blinded Assessment of Outcome and Open Label Multi-center Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04752631
• Other study ID #: Y(2020)067
• Status: Completed
• Phase: Phase 4
• Start date: March 9, 2021
• Est. completion date: July 24, 2022

Study information

• Verified date: July 2022
• Source: General Hospital of Shenyang Military Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In patients with acute stroke with an unknown time of onset, intravenous alteplase guided by a mismatch between diffusion-weighted imaging and FLAIR in the region of ischemia resulted in a significantly better functional outcome at 90 days. This trial will enroll acute ischemic stroke patients within 4.5 to 24 hours of onset. All the patients had an ischemic lesion that was visible on MRI diffusion-weighted imaging but no parenchymal hyperintensity on fluid-attenuated inversion recovery (FLAIR), which indicated that the stroke had a ischemic penumbra. Randomization will be 1:1 to TNK-tPA (experimental) or standard treatment (control), in compliance with guidelines for acute stroke. Clinical outcome was assessed by disability on the basis of the modified Rankin scale at 90 days follow-up, which will be performed by a blinded assessor.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 24, 2022
• Est. primary completion date: July 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• Tenecteplase
The participants received TNK-tPA thrombolytic therapy

Locations

Country	Name	City	State
China	Department of Neurology, General Hospital of Northern Theater Command	Shenyang

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

References & Publications (1)

Thomalla G, Simonsen CZ, Boutitie F, Andersen G, Berthezene Y, Cheng B, Cheripelli B, Cho TH, Fazekas F, Fiehler J, Ford I, Galinovic I, Gellissen S, Golsari A, Gregori J, Günther M, Guibernau J, Häusler KG, Hennerici M, Kemmling A, Marstrand J, Modrau B, Neeb L, Perez de la Ossa N, Puig J, Ringleb P, Roy P, Scheel E, Schonewille W, Serena J, Sunaert S, Villringer K, Wouters A, Thijs V, Ebinger M, Endres M, Fiebach JB, Lemmens R, Muir KW, Nighoghossian N, Pedraza S, Gerloff C; WAKE-UP Investigators. MRI-Guided Thrombolysis for Stroke with Unknown Time of Onset. N Engl J Med. 2018 Aug 16;379(7):611-622. doi: 10.1056/NEJMoa1804355. Epub 2018 May 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of symptomatic intracranial hemorrhage (sICH)	sICH was defined as 4 or more increase in NIHSS caused by hemorrhage	48 hours
Other	Proportion of intraparenchymal hemorrhage (PH1 and PH2)	Proportion of PH1 and PH2 within 48 hours after the treatment	48 hours
Other	proportion of hemorrhagic transformation	Intracranial hemorrhage assessed by MRI/CT	7 Days
Other	any bleeding events	proportion of any bleeding events	7 Days
Primary	Proportion of modified Rankin Scale (mRS) 0-1	the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome	90 Days
Secondary	Proportion of modified Rankin Scale (mRS) 0-2	the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome	90 Days
Secondary	Distribution of the modified Rankin Scale (mRS)	the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome	90 Days
Secondary	Changes in National Institute of Health stroke scale (NIHSS)	the minimum and maximum values of NIHSS are 42 and 0, respectively; higher NIHSS mean a worse outcome	24 hours and 1 week
Secondary	vascular events	The incidence of stroke and other vascular events	90 Days
Secondary	proportion of death	death due to any cause	14 days