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NCT07469293Not yet recruitingPhase 3

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

Efficacy and Safety of Intra-arterial Tenecteplase in Acute Ischemic Stroke Patients With Medium Vessel Occlusion Stroke (DATE-MeVO): A Multicenter, Prospective, Randomized Controlled, Open-label, Blinded-Endpoint Clinical Trial

Source: ClinicalTrials.gov · Last updated 20 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
488 (estimated)
First submitted
9 Feb 2026
Start date
25 Mar 2026
Primary completion date
31 Dec 2028
Lead sponsor
Southwest Hospital, China
Diseases
Stroke
NCT number
NCT07469293

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 488
  • From 25 Mar 2026 to the primary completion date, 31 Dec 2028
  • 45 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Already received intravenous thrombolysis;
  • Concurrent malignant tumors or severe systemic diseases with an expected survival time of less than 90 days;
  • Participation in another clinical interventional trial within 30 days prior to randomization or currently participating in another clinical interventional trial;

Other illness

  • Intracranial hemorrhage confirmed by cranial CT or MRI;
  • 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;
  • History of bleeding within the past month (gastrointestinal or urinary tract bleeding);
  • Severe mental disorders or inability to provide informed consent and comply with follow-up due to dementia;

Lab values

  • 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;
  • Chronic hemodialysis or severe renal insufficiency (glomerular filtration rate \< 30 mL/min or serum creatinine \> 220 μmol/L (2.5 mg/dL));

Other

  • Planned mechanical thrombectomy;
  • Intraoperative DSA showing vessel rupture, dissection, or contrast agent extravasation;
  • Pregnant or breastfeeding women;
  • Intracranial aneurysms or arteriovenous malformations;
  • Occlusions in multiple vascular territories confirmed by CTA/MRA;
  • Other reasons that the investigator deems inappropriate for participation in the trial

Who the study is looking for

  • 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

Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (45)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ankang Central Hospital
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AnkangChinaUnknown status
The People's Hospital of Anyang City
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AnyangChinaUnknown status
Affiliated Hospital of Youjiang Medical University for Nationalities
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Baise CityChinaUnknown status
Changchun Central Hospital
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ChangchunChinaUnknown status
Chengdu Second People's Hospital
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ChengduChinaUnknown status
Chongzhou People's Hospital
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ChengduChinaUnknown status
The Thrid Affiliated Hospital of CQMU
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ChongqingChinaUnknown status
The Ninth People'S Hospital of Chongqing
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ChongqingChinaUnknown status
Jiangjin Central Hospital
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ChongqingChinaUnknown status
Yunyang County People's Hospital
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ChongqingChinaUnknown status
Chonggang General Hospital
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ChongqingChinaUnknown status
Chongqing University Fuling Hospital
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ChongqingChinaUnknown status
Dali Nationality Autonomous Prefecture Hospital
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DaliChinaUnknown status
The First Affiliated Hospital of Fujian Medicaluniversity
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FuzhouChinaUnknown status
Guangyuan Central Hospital
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GuangyuanChinaUnknown status
Guilin People's Hospital
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GuilinChinaUnknown status
Qiandongnan Prefecture People's Hospital
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GuizhouChinaUnknown status
Huaibei Miners General Hospital
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HuaibeiChinaUnknown status
The People's Hospital of Jianyang City
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JianyangChinaUnknown status
The 960th Hospital of the PLA Joint Logistics Support Force
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JinanChinaUnknown status
Luoyang Mengjin People's Hospital
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LuoyangChinaUnknown status
Yiyang County People's Hospital
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LuoyangChinaUnknown status
The First Affiliated Hospital of Henan University of Science and Technology
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LuoyangChinaUnknown status
The Affiliated Hospital of Southwest Medical University
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LuzhouChinaUnknown status
The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University
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LuzhouChinaUnknown status
Mianyang 404 Hospital
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MianyangChinaUnknown status
Mudanjiang First People's Hospital
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MudanjiangChinaUnknown status
The People's Hospital Of QianNan
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QiannanChinaUnknown status
The First People's Hospital of Qingzhen
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QingzhenChinaUnknown status
Qujing Central Hospital of Yunnan Province
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QujingChinaUnknown status
Yellow River Sanmenxia Hospital
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SanmenxiaChinaUnknown status
Ninglin People's Hospital
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ShangqiuChinaUnknown status
The First People's Hospital of Shangqiu
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ShangqiuChinaUnknown status
The People's Hospital Of An Jv
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SuiningChinaUnknown status
Yutian Hospital
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TangshanChinaUnknown status
Wuhan Puren Hospital
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WuhanChinaUnknown status
Zhongnan Hospital of Wuhan University
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WuhanChinaUnknown status
Xiangyang No.1 People's Hospital
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XiangyangChinaUnknown status
Yaan People's Hospital
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Ya'anChinaUnknown status
Yichang Central People's Hospital
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YichangChinaUnknown status
Zhengzhou Central Hospital
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ZhengzhouChinaUnknown status
Zhoukou Central Hospital
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ZhoukouChinaUnknown status
Zhumadian Central Hospital
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ZhumadianChinaUnknown status
Zhuzhou Central Hospital
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ZhuzhouChinaUnknown status
Zigong Third People's Hospital
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ZigongChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.