NCT07047014 Advancing Reperfusion Therapy for Ischemic Stroke (ARTS): Tenecteplase in Medium Vessel Occlusion (MeVO) for Acute Ischemic Stroke
| NCT ID | NCT07047014 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Beijing Tiantan Hospital |
| Condition | Stroke, Ischemic |
| Study Type | INTERVENTIONAL |
| Enrollment | 596 participants |
| Start Date | 2025-07-30 |
| Primary Completion | 2027-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 596 participants in total. It began in 2025-07-30 with a primary completion date of 2027-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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)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 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.
Contact & Investigator
Ziqi Xu
PRINCIPAL INVESTIGATOR
First Affiliated Hospital of Zhejiang University
Frequently Asked Questions
Who can join the NCT07047014 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke, Ischemic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07047014 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 596 participants.
Is NCT07047014 currently recruiting?
Yes, NCT07047014 is actively recruiting participants. Contact the research team at xiongyunyun@bjtth.org for enrollment information.
Where is the NCT07047014 trial being conducted?
This trial is being conducted at Beijing, China, Jiuquan, China, Shijiazhuang, China, Jiyuan, China and 3 additional locations.
Who is sponsoring the NCT07047014 clinical trial?
NCT07047014 is sponsored by Beijing Tiantan Hospital. The principal investigator is Ziqi Xu at First Affiliated Hospital of Zhejiang University. The trial plans to enroll 596 participants.
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