Efficacy and Safety of Intra-arterial Tenecteplase in Acute Ischemic Stroke Patients With Medium Vessel Occlusion Stroke (DATE-MeVO)

Starting soon · Phase 3

Conditions studied: Acute Ischemic Stroke

In brief

DATE-MeVO is an investigator-initiated, multicenter, prospective, randomized controlled, open-label, blinded endpoint (PROBE) clinical trial aiming at evaluating the efficacy and safety of tenecteplase combined with standard medications in acute ischemic stroke patients with medium vessel occlusion stroke within 24 hours of onset.

Key facts

Study ID

NCT07469293

Run by

Southwest Hospital, China

People needed

488

Starts

2026-03-25

Expected to finish

2028-12-31

Last updated by the study team

2026-03-20

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years old
• Acute isolated intracranial medium vessel occlusion (Distal middle cerebral artery M2; M3 and M4 segments of the middle cerebral artery; A1-A4 segments of the anterior cerebral artery; P1-P3 segments of the posterior cerebral artery), confirmed by imaging, with symptom onset to randomization within 24 hours;
• NlHSS score ≥ 5
• CT scan performed within 24 hours confirming that the ischemic lesion does not involve more than one-third of the territory supplied by the responsible vessel (no evidence of early large infarction)
• Patients with premorbid mRS 0 or 1
• Written informed consent obtained from the participant or a legally authorized representative

You may not qualify if…

• Intracranial hemorrhage confirmed by cranial CT or MRI;
• Already received intravenous thrombolysis;
• Planned mechanical thrombectomy;
• Intraoperative DSA showing vessel rupture, dissection, or contrast agent extravasation;
• Pregnant or breastfeeding women;
• Allergy to contrast agents or tenecteplase;
• Systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg, and failure to control with oral antihypertensive medications;
• Genetic or acquired bleeding disorders, coagulation factor deficiencies; coagulation dysfunction, INR > 1.7, or use of novel oral anticoagulants within 48 hours;
• Blood glucose < 2.8 mmol/L (50 mg/dL) or > 22.2 mmol/L (400 mg/dL), platelet count < 100 × 10\^9/L;
• History of bleeding within the past month (gastrointestinal or urinary tract bleeding);
• Chronic hemodialysis or severe renal insufficiency (glomerular filtration rate < 30 mL/min or serum creatinine > 220 μmol/L (2.5 mg/dL));
• Severe mental disorders or inability to provide informed consent and comply with follow-up due to dementia;
• Concurrent malignant tumors or severe systemic diseases with an expected survival time of less than 90 days;
• Intracranial aneurysms or arteriovenous malformations;
• Participation in another clinical interventional trial within 30 days prior to randomization or currently participating in another clinical interventional trial;
• Occlusions in multiple vascular territories confirmed by CTA/MRA;
• Other reasons that the investigator deems inappropriate for participation in the trial

Where it is running

• Affiliated Hospital of Youjiang Medical University for Nationalities — Baise City, Guangxi, China
• Guilin People'S Hospital — Guilin, Guangxi, China
• The People's Hospital Of QianNan — Qiannan, Guizhou, China
• Chongzhou People's Hospital — Chengdu, Sichuan, China
• Dali Nationality Autonomous Prefecture Hospital — Dali, Yunnan, China
• Qujing Central Hospital of Yunnan Province — Qujing, Yunnan, China
• Ankang Central Hospital — Ankang, China
• The People'S Hospital of Anyang City — Anyang, China
• Changchun Central Hospital — Changchun, China
• Chengdu Second People's Hospital — Chengdu, China
• Chonggang General Hospital — Chongqing, China
• Chongqing University Fuling Hospital — Chongqing, China
• Jiangjin Central Hospital — Chongqing, China
• The Ninth People'S Hospital of Chongqing — Chongqing, China
• The Thrid Affiliated Hospital of CQMU — Chongqing, China
• Yunyang County People'S Hospital — Chongqing, China
• The First Affiliated Hospital of Fujian Medicaluniversity — Fuzhou, China
• Guangyuan Central Hospital — Guangyuan, China
• Qiandongnan Prefecture People's Hospital — Guizhou, China
• Huaibei Miners General Hospital — Huaibei, China
• The People's Hospital of Jianyang City — Jianyang, China
• The 960th Hospital of the PLA Joint Logistics Support Force — Jinan, China
• Luoyang Mengjin People's Hospital — Luoyang, China
• The First Affiliated Hospital of Henan University of Science and Technology — Luoyang, China
• Yiyang County People'S Hospital — Luoyang, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.