Tests tenecteplase in stroke caused by blocked medium-sized brain blood vessels
Tests tenecteplase against standard care in adults with acute ischemic stroke.
Plain-language title generated from the registry record
Registry title: Advancing Reperfusion Therapy for Ischemic Stroke (ARTS): Tenecteplase in Medium Vessel Occlusion (MeVO) for Acute Ischemic Stroke
Key facts
- Where
- Beijing, Hangzhou, Jiuquan, Jiyuan, Lingbao, Nantong, and Shijiazhuang, ChinaSee the 7 sites
- Phase
- Phase 3
Where in China
- Beijing Tiantan HospitalBeijing, ChinaNot yet recruiting
- The first Affiliated Hospital, School of Medicine, Zhejiang University.Hangzhou, ChinaNot yet recruiting
- Jiuquan City People's HospitalJiuquan, ChinaTaking people
- Jiyuan Traditional Chinese Medicine HospitalJiyuan, ChinaTaking people
- The first people hospital of lingbaoLingbao, ChinaTaking people
- Hai'an People's HospitalNantong, ChinaTaking people
- Xingtang People's HospitalShijiazhuang, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Beijing Tiantan Hospital
- Trial code
- NCT07047014
- Record updated
- 1 April 2026
- Original description
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.Read full original descriptionShow less
Advancing Reperfusion Therapy for Ischemic Stroke (ARTS): Tenecteplase in Medium Vessel Occlusion (MeVO) for Acute Ischemic Stroke
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.
Inclusion: (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.
Exclusion: (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; (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; (17) Participation in other interventional clinical trials within the previous 3 months; (1)Allergy to tenecteplase; (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; (11)Any terminal illness such that the patient would not be expected to survive more than 1 year; (14)Acute or past intracerebral hemorrhage (ICH) identified by CT or MRI; (6)Blood glucose <2.8 or >22.2 mmol/L (point of care glucose testing is acceptable); (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); (2)Rapidly improving symptoms at the discretion of the investigator; (4)Intention to undergo endovascular treatment; (5)Persistent blood pressure elevation (systolic ≥185 mmHg or diastolic ≥110 mmHg), despite blood pressure-lowering treatment; (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); (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.