Actively Recruiting
Advancing Reperfusion Therapy for Ischemic Stroke (ARTS): Tenecteplase in Medium Vessel Occlusion (MeVO) for Acute Ischemic Stroke
Led by Beijing Tiantan Hospital · Updated on 2026-04-01
596
Participants Needed
7
Research Sites
13 weeks
Total Duration
On this page
Sponsors
B
Beijing Tiantan Hospital
Lead Sponsor
F
First Affiliated Hospital of Zhejiang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying adult patients who have had an acute ischemic stroke caused by blockage in medium-sized brain blood vessels. This trial aims to evaluate the effectiveness and safety of tenecteplase compared to standard medical care in patients treated within 4.5 to 24 hours after stroke symptoms begin. The study focuses on a specific group with confirmed medium vessel occlusions and uses imaging methods to select participants based on brain blood flow and damage. Participants will be randomly assigned to receive either a single intravenous dose of tenecteplase (0.25 mg per kilogram, up to 25 mg) or standard medical treatment, which may include aspirin and/or clopidogrel, following national stroke care guidelines. Treatments will be given between 4.5 and 24 hours after the patient was last seen well. The trial is controlled, randomized, and open-label with blinded evaluation of outcomes. During the study, participants will be monitored through clinical assessments including the National Institutes of Health Stroke Scale and the modified Rankin scale to measure disability at 90 days. Imaging tests such as CT or MRI perfusion scans will be used to evaluate brain blood flow and damage. Researchers will track neurological improvement, adverse events, bleeding events, and quality of life up to one year after treatment. The main outcome is the proportion of patients achieving minimal disability at 90 days post-treatment.
CONDITIONS
Brief Title
Advancing Reperfusion Therapy for Ischemic Stroke (ARTS): Tenecteplase in Medium Vessel Occlusion (MeVO) for Acute Ischemic Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Acute ischemic stroke symptoms started within 4.5 to 24 hours, including wake-up or unwitnessed stroke
- Primary medium vessel occlusions confirmed by CTA or MRA in specific brain artery segments
- Neuroimaging criteria: target mismatch on CT perfusion or MRI, or ASPECTS/PC-ASPECTS score of 8 or more if perfusion imaging is unavailable
- Pre-stroke modified Rankin scale score of 1 or less
- Baseline NIH Stroke Scale (NIHSS) score of 6 or more, or 3-5 with disabling symptoms
- Written informed consent from patient or legal representative
You will not qualify if you...
- Allergy to tenecteplase
- Rapidly improving stroke symptoms
- Severe consciousness impairment, seizures, or mental illness preventing cooperation
- Planned endovascular treatment
- Persistent high blood pressure despite treatment
- Blood glucose below 2.8 or above 22.2 mmol/L
- Active internal bleeding or high bleeding risk within recent weeks
- Known clotting disorders or anticoagulant use with abnormal tests
- Platelet count below 100,000/mm3
- Recent ischemic stroke, heart attack, brain injury, or brain surgery within 3 months
- Terminal illness with expected survival under 1 year
- Unable to perform required perfusion imaging
- Extensive brain tissue damage on CT or MRI
- Current or past brain hemorrhage
- Pregnancy, breastfeeding, or refusal to use contraception
- Unlikely to follow trial protocol or attend follow-up
- Participation in other interventional trials in last 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Single treatment within 4.5 to 24 hours after stroke onset
Participants receive either a single intravenous bolus of tenecteplase or standard medical treatment according to guidelines.
1 treatment visit (in-person)
Duration - Up to 90 days and 1 year after treatment
Participants are monitored for safety and outcomes including neurological improvement and adverse events.
Visits at 24 hours, 36 hours, 90 days, and 1 year post-treatment
Trial Site Locations
Total: 7 locations
1
Beijing tiantan hospital
Beijing, Beijing Municipality, China, 100070
Not Yet Recruiting
2
Jiuquan city people's hospital
Jiuquan, Gansu, China, 736100
Actively Recruiting
3
Xingtang People's Hospital
Shijiazhuang, Hebei, China, 050600
Actively Recruiting
4
Jiyuan Traditional Chinese Medicine Hospital
Jiyuan, Henan, China, 459000
Actively Recruiting
5
The first people hospital of lingbao
Lingbao, Henan, China, 472500
Actively Recruiting
6
Hai'an People's Hospital
Nantong, Jiangsu, China, 226600
Actively Recruiting
7
The First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Not Yet Recruiting
Research Team
Y
Yunyun Xiong
Z
Ziqi Xu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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