EXtending the Time Window for Thrombolysis in Posterior Circulation Stroke Without Early CT Signs
- Conditions
- Stroke, Acute Ischemic
- Registration Number
- NCT05429476
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 234
Inclusion Criteria:<br><br> 1. Patients presenting with clinical signs of acute ischemic stroke between 4.5 and 24<br> hours from stroke onset, or wake-up stroke and unwitnessed stroke (if within 4.5 to<br> 24 hours from the last known well time).<br><br> 2. Patients aged > 18 years (or as per local requirements).<br><br> 3. NIHSS = 1.<br><br> 4. Patients with a posterior circulation ASPECT score (PC-ASPECTS) = 7. If MRI is<br> performed first and the PC-ASPECTS on diffusion-weighted imaging (DWI) is = 7, a<br> non-contrast head CT is not required. If PC-ASPECTS on DWI is < 7, the subsequent<br> non-contrast CT must show a PC-ASPECTS = 7 for inclusion.<br><br> 5. Posterior circulation stroke confirmation criteria: If MRI is performed, infarction<br> confirmed by DWI is sufficient. If CT is performed, the non-contrast CT scan must<br> not refute posterior circulation stroke, and clinical signs and symptoms must<br> support the diagnosis, as confirmed by experienced clinicians. If clinical symptoms<br> are atypical, CTA showing symptomatic stenosis or occlusion of large posterior<br> circulation vessels, or CT perfusion showing symptomatic hypoperfusion, can provide<br> additional evidence, though advanced imaging is not mandatory.<br><br> 6. Pre-stroke mRS score < 2.<br><br> 7. Informed consent has been obtained from the patient, a family member, or a legally<br> responsible person, depending on local ethics requirements.<br><br>Exclusion Criteria:<br><br> 1. Intended to proceed to endovascular treatment.<br><br> 2. Contraindications for alteplase:<br><br> Allergy to alteplase. Rapidly improving symptoms at the discretion of the<br> investigator. The presence of epileptic seizures, hemiplegia after seizures (Todd's<br> palsy), or other neurological/mental illnesses that prevent cooperation or<br> willingness to participate.<br><br> Persistent blood pressure elevation (systolic =180 mmHg or diastolic =100 mmHg)<br> despite treatment.<br><br> Blood glucose levels outside the acceptable range (<2.8 or >22.2 mmol/L), with<br> point-of-care glucose testing considered valid.<br><br> High risk of bleeding due to active internal bleeding, major surgery, trauma,<br> gastrointestinal, or urinary tract hemorrhage within the previous 21 days, or<br> arterial puncture at a non-compressible site within the previous 7 days.<br><br> Known impairments in coagulation due to comorbid disease or anticoagulant use,<br> including an INR >1.7 or prothrombin time >15 seconds for those on warfarin, recent<br> use of direct thrombin inhibitors or direct factor Xa inhibitors without reversal<br> capability, or full-dose heparin/heparinoid within the last 24 hours with an aPTT<br> above normal limits.<br><br> Known defect in platelet function or a platelet count below 100,000/mm³. History of<br> ischemic stroke, myocardial infarction, intracranial hemorrhage, severe traumatic<br> brain injury, or intraspinal operation within the previous 3 months, or known<br> intracranial neoplasm, arteriovenous malformation, or giant aneurysm.<br><br> Acute or past intracerebral hemorrhage identified by CT or MRI. Infarction of the<br> anterior circulation confirmed by MRI, or vascular examination indicating occlusion<br> of large anterior circulation vessels, or perfusion imaging showing hypoperfusion<br> changes in the anterior circulation area.<br><br> Pregnancy, nursing, or unwillingness to use effective contraceptive measures during<br> the trial period.<br><br> Likelihood of non-adherence to the trial protocol or follow-up. Any condition that,<br> in the judgment of the investigator, could impose hazards if study therapy is<br> initiated or affect patient participation in the study.<br><br> Participation in other interventional clinical trials within the previous 3 months.<br><br> 3. Life expectancy of less than three months.<br><br> 4. The judgment is left to the discretion of the investigator.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Independent recovery assessed by ratio of modefied Rankin Scale (mRS) score of 0-2 (%) at 90 ± 7 days
- Secondary Outcome Measures
Name Time Method Ordinal distribution of modefied Rankin Scale (mRS) score at 90 ± 7 days;Excellent recovery assessed by the ratio of modefied Rankin Scale (mRS) score of 0-1 (%) at 90 ± 7 days;The ratio of modefied Rankin Scale (mRS) score of 0 (%) at 90 ± 7 days;Clinical response rate at 24-36 hours defined as an improvement on NIHSS score = 8 points compared with the initial deficit or a score = 1;Symptomatic Intracerebral Hemorrhage (sICH) at 24-36 hours;Parenchymal hematoma type 2 (PH2) at 24-36 hours;Mortality within 90 days;Adverse events (AEs)/ serious adverse events (SAEs) within 90 days