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Advancing Reperfusion Therapy for Ischemic Stroke (ARTS): Tenecteplase in Medium Vessel Occlusion (MeVO) for Acute Ischemic Stroke
Sponsor: Beijing Tiantan Hospital
Summary
Results from recent several trials provided data showing limits to the effectiveness of thrombectomy for ischemic stroke due to medium vessel occlusions.The benefit-risk profile of thrombolysis for these patients has never been investigated. We initiated a multicenter, prospective, randomized, open label, blinded-endpoint (PROBE) controlled trial to evaluate the efficacy and safety of tenecteplase (0.25mg/kg, maximum dose 25mg) compared to standard medical care for patients with acute ischemic stroke due to medium vessel occlusion (MeVO) within 4.5 to 24 hours from symptom onset.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
596
Start Date
2025-07-30
Completion Date
2027-06-30
Last Updated
2026-04-01
Healthy Volunteers
No
Conditions
Interventions
Tenecteplase (0.25mg/kg)
Each vial of tenecteplase is reconstituted with 3 ml sterile water for injection and adjusted to a concentration of 5.33 mg/ml. Calculate the total amount of drug according to the subject's actual body weight and measure the required drug volume. The maximum dose should not exceed 25mg. Tenecteplase should be given as a single, intravenous bolus (within 5-10 seconds).
Standard medical treatment
Aspirin combined with clopidogrel, aspirin alone, or clopidogrel alone after randomization at the discretion of site researchers according to Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2023.
Locations (7)
Beijing tiantan hospital
Beijing, Beijing Municipality, China
Jiuquan city people's hospital
Jiuquan, Gansu, China
Xingtang People's Hospital
Shijiazhuang, Hebei, China
Jiyuan Traditional Chinese Medicine Hospital
Jiyuan, Henan, China
The first people hospital of lingbao
Lingbao, Henan, China
Hai'an People's Hospital
Nantong, Jiangsu, China
The First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China