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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who had an ischemic stroke caused by a blocked medium-sized brain artery, 4.5 to 24 hours after symptoms began. It tests tenecteplase against standard medical care.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Acute ischemic stroke with a blocked medium vessel confirmed by CTA/MRA, with symptoms starting 4.5 to 24 hours ago (counted from the last time the person was seen normal). Brain imaging must show salvageable tissue, or an ASPECTS score of 8 or more if perfusion imaging is not available. Stroke severity (NIHSS) must be 6 or more, or 3-5 with disabling symptoms.
- Earlier treatment
- Before the stroke, daily functioning was good (modified Rankin scale score 1 or less). People who plan to have endovascular treatment cannot join. Anyone in another interventional trial within the previous 3 months cannot join.
- Biomarker or test result
- Perfusion imaging showing an ischemic core under 70mL, a mismatch ratio above 1.2 and a mismatch volume above 10mL.
Main reasons for not taking part
- Allergy to tenecteplase
- Active internal bleeding or high risk of bleeding
- Bleeding problems, or blood thinner use that affects clotting
- Previous brain bleeding, or a stroke or heart attack in the previous 3 months
- Pregnant or nursing women
Read by machine on 12 November 2026.
Where in China
- Beijing Tiantan HospitalBeijing, ChinaContact: Yunyun XiongNot yet recruiting
- The first Affiliated Hospital, School of Medicine, Zhejiang University.Hangzhou, ChinaContact: Yunyun XiongNot yet recruiting
- Jiuquan City People's HospitalJiuquan, ChinaContact: Shibin WenTaking people
- Jiyuan Traditional Chinese Medicine HospitalJiyuan, ChinaContact: Hongqin YangTaking people
- The first people hospital of lingbaoLingbao, ChinaContact: Wei WuTaking people
- Hai'an People's HospitalNantong, ChinaContact: Xiaowei XuTaking people
- Xingtang People's HospitalShijiazhuang, ChinaContact: Yanxin WangTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.