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RECRUITING
NCT07047014
PHASE3

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

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

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).

DRUG

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