Advancing Reperfusion Therapy for Ischemic Stroke (ARTS): Tenecteplase in Medium Vessel Occlusion (MeVO) for Acute Ischemic Stroke
ARTS-MeVO
1 other identifier
interventional
596
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2025
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2025
CompletedFirst Posted
Study publicly available on registry
July 2, 2025
CompletedStudy Start
First participant enrolled
July 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
April 1, 2026
March 1, 2026
1.7 years
June 24, 2025
March 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
mRS score ≤ 1 at 90 days
The proportion of patients with an mRS score ≤ 1 at 90 days
90 days
Secondary Outcomes (10)
mRS score
90 days
mRS score ≤ 2
90 days
Early neurological improvement
24 hours
mRS 5-6
90 days
EuroQol 5-Dimension (EQ-5D) index
90 days and 1 year
- +5 more secondary outcomes
Study Arms (2)
Tenecteplase (0.25 mg/kg)
EXPERIMENTALTenecteplase (0.25 mg/kg, max 25 mg)
Standard medical treatment
ACTIVE COMPARATORAspirin combined with clopidogrel, aspirin alone, or clopidogrel alone, etc.
Interventions
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).
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.
Eligibility Criteria
You may qualify if:
- (1)Age≥18 years old;
- (2)Acute ischemic stroke symptom onset within 4.5 - 24 hours; including wake-up stroke and unwitnessed stroke, onset time refers to "last-seen normal time";
- (3)Primary medium vessel occlusions confirmed by CTA/MRA, including distal M2/M3 segments of the middle cerebral artery (MCA), A1/A2/A3 segments of the anterior cerebral artery (ACA), and P1/P2/P3 segments of the posterior cerebral artery (PCA) and responsible for the signs and symptoms of acute ischemic stroke;
- (4)Neuroimaging criteria: a) Perfusion criteria:Target mismatch profile on CT perfusion or MRI+MR perfusion (ischemic core volume \<70mL, mismatch ratio \>1.2, mismatch volume \>10mL); b) If neither MRI or CT perfusion is available at the site : an Alberta Stroke Program Early CT Score \[ASPECTS\] of 8 or more on NCCT /MRI-DWI or PC-ASPECTS of 8 or more on NCCT/MRI-DWI.
- (5)Pre-stroke modified Rankin scale (mRS) score ≤1;
- (6)Baseline National Institutes of Health Stroke Scale (NIHSS) ≥6 or NIHSS 3-5 with disabling symptoms;
- (7)Written informed consent from patients or their legally authorized representatives.
You may not qualify if:
- (1)Allergy to tenecteplase;
- (2)Rapidly improving symptoms at the discretion of the investigator;
- (3)NIHSS consciousness score 1a \>2, or epileptic seizure, hemiplegia after seizures (Todd's palsy) or other neurological/mental illness such that the patient is not able to cooperate or unwilling to cooperate;
- (4)Intention to undergo endovascular treatment.
- (5)Persistent blood pressure elevation (systolic ≥185 mmHg or diastolic ≥110 mmHg), despite blood pressure-lowering treatment;
- (6)Blood glucose \<2.8 or \>22.2 mmol/L (point of care glucose testing is acceptable);
- (7) Active internal bleeding or at high risk of bleeding, e.g., major surgery, trauma or gastrointestinal or urinary tract hemorrhage within the previous 21 days, or arterial puncture at a non-compressible site within the previous 7 days;
- (8)Any known impairment in coagulation due to comorbid disease or anticoagulant use. If on warfarin, then INR \>1.7 or prothrombin time \>15 seconds; use of any direct thrombin inhibitors or direct factor Xa inhibitors during the last 48 hours unless reversal of dabigatran can be achieved with idarucizumab; any full dose heparin/heparinoid during the last 24 hours or with an APTT greater than the upper limit of normal;
- (9)Known defect of platelet function or platelet count below 100,000/mm3 (NB patients taking antiplatelet medication can be included);
- (10)Ischemic stroke or myocardial infarction in previous 3 months, previous intracranial hemorrhage, severe traumatic brain injury or intracranial or intraspinal operation in previous 3 months, or known intracranial neoplasm, arteriovenous malformation, or giant aneurysm;
- (11)Any terminal illness such that the patient would not be expected to survive more than 1 year;
- (12) Unable to perform CTP or PWI;
- (13)Hypodensity in \>1/3 MCA territory on non-contrast CT or hypodensity outside the current perfusion lesion suggesting distal clot migration (secondary MeVO);
- (14)Acute or past intracerebral hemorrhage (ICH) identified by CT or MRI;
- (15)Pregnant women, nursing mothers, or reluctance to use effective contraceptive measures during the period of the trial;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- First Affiliated Hospital of Zhejiang Universitycollaborator
- Beijing Tiantan Hospitallead
- Chinese Stroke Associationcollaborator
Study Sites (7)
Beijing tiantan hospital
Beijing, Beijing Municipality, 100070, China
Jiuquan city people's hospital
Jiuquan, Gansu, 736100, China
Xingtang People's Hospital
Shijiazhuang, Hebei, 050600, China
Jiyuan Traditional Chinese Medicine Hospital
Jiyuan, Henan, 459000, China
The first people hospital of lingbao
Lingbao, Henan, 472500, China
Hai'an People's Hospital
Nantong, Jiangsu, 226600, China
The First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ziqi Xu
First Affiliated Hospital of Zhejiang University
- PRINCIPAL INVESTIGATOR
Yunyun Xiong
Beijing Tiantan Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 24, 2025
First Posted
July 2, 2025
Study Start
July 30, 2025
Primary Completion (Estimated)
March 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
April 1, 2026
Record last verified: 2026-03