Status:
NOT_YET_RECRUITING
Intravenous Thrombolytic Therapy for Acute Ischemic Stroke Patients with Low NIHSS and Non-disabling Deficits
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Thrombosis
Acute Ischemic Stroke (AIS)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Minor stroke is considered an acute ischemic stroke (AIS) that has a National Institute of Health Stroke Scale (NIHSS) score ≤ 5 points. About 1/3 patients with mild stroke have poor prognosis, whethe...
Eligibility Criteria
Inclusion
- Patients with clinical signs of acute ischemic stroke within 4.5 hours of onset or awakening with stroke (if within 4.5 hours from the midpoint of sleep).
- Patinet's age is \>18 years
- Patients with NIHSS ≤ 5, a limb-related NIHSS item score of 0, and with any of the following NIHSS item ≥2: Best Gaze, Visual, Facial palsy, Limb ataxia, Sensory, Best language, Dysarthria, Extinction and Inattention.
Exclusion
- (1) Plan to receive endovascular treatment; (2) Pre-stroke mRS score \> 2 (3) Contraindications for IVT：
- Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, epidural hematoma, etc.)
- Previous history of intracranial hemorrhage
- Severe head trauma or stroke history within the last 3 months
- Intracranial tumors, giant intracranial aneurysms
- Intracranial or spinal surgery within the recent 3 months
- Major surgical procedures within the last 2 weeks
- Gastrointestinal or urinary tract bleeding within the last 3 weeks
- Active visceral bleeding
- Aortic arch dissection
- Arterial puncture in a site within the last 1 week that is not easy to compress and stop bleeding
- Elevated blood pressure: Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg
- Acute bleeding tendency, including platelet count \< 100 × 10⁹/L or other conditions
- Received low-molecular-weight heparin treatment within 24 hours
- Oral anticoagulants (warfarin) with INR \> 1.7 or PT \> 15 s; Receiving heparin treatment with aPTT above the upper limit of the normal range within the last 24 hours of onset, Receiving thrombin inhibitors and factor Xa inhibitors within the last 48 hours of onset.
- Blood sugar \< 2.8 or \> 22.22 mmol/L
- Head CT or MRI indicates large-area infarction (infarction area ≥ 1/3 of the middle cerebral artery supply area) (4) The judgment is left to the discretion of the investigator
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT06115070
Start Date
March 1 2025
End Date
December 31 2028
Last Update
March 6 2025
Active Locations (1)
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1
Second Affiliated Hospital of Zhejiang University, School of Medicine
Hangzhou, China