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

Launched by BEIJING TIANTAN HOSPITAL · Jun 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment for a type of stroke called an acute ischemic stroke, where a medium-sized blood vessel in the brain gets blocked. Researchers want to see if a medicine called tenecteplase can safely and effectively help patients recover better compared to the usual care. The treatment would be given within 4.5 to 24 hours after stroke symptoms start, including strokes that happen during sleep or when the exact time of onset isn’t known.

Adults 18 years and older who have had a stroke caused by a blockage in specific medium-sized brain arteries may be eligible to participate. To join, patients need to have certain brain scans showing the blockage and meet other health criteria, like having moderate stroke symptoms and being generally independent before the stroke. Participants in the trial will be randomly assigned to receive either tenecteplase or standard treatment, and their recovery and safety will be closely monitored. This study is important because it aims to find better treatment options for strokes that affect medium-sized vessels, a group for which current therapies have some limitations. The trial is not yet open for enrollment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • (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)Pre-stroke modified Rankin scale (mRS) score ≤1; (5)Baseline National Institutes of Health Stroke Scale (NIHSS) ≥6 or NIHSS 3-5 with disabling symptoms; (6)Neuroimaging criteria: Target mismatch profile on CT perfusion or MRI+MR perfusion (ischemic core volume \<70mL, mismatch rate \>1.2, mismatch volume \>10mL); (7)Written informed consent from patients or their legally authorized representatives.
• Exclusion Criteria:
• • (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; (16)Unlikely to adhere to the trial protocol or follow-up; (17) Participation in other interventional clinical trials within the previous 3 months.