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Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅳ
Sponsor: Beijing Tiantan Hospital
Summary
The purpose of this study is to evaluate the efficacy and safety of intravenous tenecteplase (0.25 mg/kg) compared with standard therapy in patients with acute ischemic stroke presenting with mild symptoms-defined as a National Institutes of Health Stroke Scale (NIHSS) score ≤5 accompanied by persistent unilateral limb weakness or speech impairment within 4.5 hours of onset.
Official title: TNK-tPA Treatment for Acute Minor Ischemic Stroke:A Randomized, Double-blind, Double-dummy Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1386
Start Date
2025-07-09
Completion Date
2026-10-31
Last Updated
2025-07-24
Healthy Volunteers
No
Conditions
Interventions
rhTNK-tPA
rhTNK-tPA 0.25mg/kg, the maximum dose does not exceed 25mg: 1 vial is dissolved in 3ml of sterile water for injection to prepare a medicinal solution with a concentration of 5.33mg/ml. Calculate the total amount of the drug according to the weight of participant, and the maximum dose shall not exceed 25 mg. It is administered as a single bolus intravenous injection, and the injection is completed within 5-10 seconds. Additionally, placebo oral aspirin and clopidogrel are given. Aspirin 100 mg and clopidogrel 300 mg are administered within 6 ± 2 hours following thrombolytic therapy.
Control group (Aspirin combined with clopidogrel)
Dual antiplatelets with aspirin 100mg and clopidogrel 300mg, plus placebo intravenous rhTNK-tPA. Placebo oral aspirin and clopidogrel are administered within 6 ± 2 hours following intravenous placebo.
Locations (1)
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China