Status:
COMPLETED
MRI-guided thrOmbolysis for Stroke bEyond Time Window by TNK
Lead Sponsor:
General Hospital of Shenyang Military Region
Conditions:
Stroke
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 feasibili...
Detailed 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 significant...
Eligibility Criteria
Inclusion
- Patient age 18-80 years;
- The time from onset to treatment: 4.5-24 hours;
- Acute Ischemic stroke confirmed by MRI;
- NIHSS score ：6-25, or NIHSS score≤ 5 but culprit vessel occlusion or severe stenosis ( ICA, MCA-M1/M2, ACA) on CTA/MRA;
- 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;
- the first onset of ischemic stroke or previous stroke with no obvious sequelae (mRS≤1);
- Signed informed consent
Exclusion
- Planned endovascular treatment;
- Serious neurological deficits before onset ( mRS ≥ 2);
- Obvious head injuries or strokes within 3 months;
- Subarachnoid hemorrhage;
- History of intracranial hemorrhage;
- Intracranial tumor, arteriovenous malformation or aneurysm;
- Intracranial or spinal cord surgery within 3 months;
- Arterial puncture at a noncompressible site within the previous seven days;
- Active internal hemorrhage;
- coagulation abnormalities: platelet count of \<100000/mm3 ；
- Aortic arch dissection；
- Heparin therapy within 24 hours;
- Infective endocarditis；
- Oral warfarin is being taken and INR\>1.6 or APTT abnormal；
- oral anticoagulation therapy；
- Systolic pressure ≥185 mmHg or diastolic pressure ≥110 mmHg；
- Blood glucose \< 50 mg/dl (2.7mmol/L)；
- Pregnancy;
- Neurological deficit after epileptic seizures;
- Major surgery within 1 month;
- Gastrointestinal or urinary tract hemorrhage within the previous 30 days;
- Myocardial infarction within 3 months;
- allergy to study drugs;
- Contradictory to MRI examination；
- MRI image not qualified for evaluation；
- Other serious illness；
- Participating in other clinical trials within 3 months;
- patients not suitable for this clinical studies considered by researcher.
Key Trial Info
Start Date :
March 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04752631
Start Date
March 9 2021
End Date
July 24 2022
Last Update
August 2 2022
Active Locations (1)
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1
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, China, 110016