RecruitingPhase 3NCT07047014

Advancing Reperfusion Therapy for Ischemic Stroke (ARTS): Tenecteplase in Medium Vessel Occlusion (MeVO) for Acute Ischemic Stroke


Sponsor

Beijing Tiantan Hospital

Enrollment

596 participants

Start Date

Jul 30, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Standard medical treatment and a drug called Tenecteplase (0.25mg/kg) for people with medium vessel occlusions and stroke, ischemic. The study is currently recruiting participants at 7 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTenecteplase (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).

DRUGStandard 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

View Full Details on ClinicalTrials.gov

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NCT07047014


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