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Clinical Trials in China / NCT07469293
Starting soon Phase 3

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

NCT07469293 · tracked via the Priya Life Science China tracker
Sponsor
Southwest Hospital, China
Phase
Phase 3
Started
2026-03-25
Last updated
2026-03-20

Condition(s) studied

Acute Ischemic Stroke

Investigational drug(s) / intervention(s)

Intra-arterial thrombolysisStandard medical treatment

Intra-arterial thrombolysis: A standardized microcatheter-based technique was used to administer recombinant TNK-tPA directly into the thrombus. The total dose (0.0625 mg/kg, max 6.25 mg) was delivered in three equal parts: distally, within the mid-clot, and proximally. Angiographic reassessment at 5 minutes determined if a second identical dose was required (max cumulative dose: 0.125 mg/kg). The procedure was continuously monitored and could be terminated immediately for safety concerns.

Standard medical treatment: Standard medical treatment

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥18 years old 2. 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; 3. NlHSS score ≥ 5 4. 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) 5. Patients with premorbid mRS 0 or 1 6. Written informed consent obtained from the participant or a legally authorized representative Exclusion Criteria: 1. Intracranial hemorrhage confirmed by cranial CT or MRI; 2. Already received intravenous thrombolysis; 3. Planned mechanical thrombectomy; 4. Intraoperative DSA showing vessel rupture, dissection, or contrast agent extravasation; 5. Pregnant or breastfeeding women; 6. Allergy to contrast agents or tenecteplase; 7. Systolic blood pressure \> 185 mmHg or diastolic blood pressure \> 110 mmHg, and failure to control with oral antihypertensive medications; 8. Genetic or acquired bleeding disorders, coagulation factor deficiencies; coagulation dysfunction, INR \> 1.7, or use of novel oral anticoagulants within 48 hours; 9. Blood glucose \< 2.8 mmol/L (50 mg/dL) or \> 22.2 mmol/L (400 mg/dL), platelet count \< 100 × 10\^9/L; 10. History of bleeding within the past month (gastrointestinal or urinary tract bleeding); 11. Chronic hemodialysis or severe renal insufficiency (glomerular filtration rate \< 30 mL/min or serum creatinine \> 220 μmol/L (2.5 mg/dL)); 12. Severe mental disorders or inability to provide informed consent and comply with follow-up due to dementia; 13. Concurrent malignant tumors or severe systemic diseases with an expected survival time of less than 90 days; 14. Intracranial aneurysms or arteriovenous malformations; 15. Participation in another clinical interventional trial within 30 days prior to randomization or currently participating in another clinical interventional trial; 16. Occlusions in multiple vascular territories confirmed by CTA/MRA; 17. Other reasons that the investigator deems inappropriate for participation in the trial

Primary outcome measure(s)

Trial sites (45)

FacilityCityRegionStatus
Affiliated Hospital of Youjiang Medical University for Nationalities Baise City Guangxi
Guilin People'S Hospital Guilin Guangxi
The People's Hospital Of QianNan Qiannan Guizhou
Chongzhou People's Hospital Chengdu Sichuan
Dali Nationality Autonomous Prefecture Hospital Dali Yunnan
Qujing Central Hospital of Yunnan Province Qujing Yunnan
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
The Affiliated Hospital of Southwest Medical University Luzhou China
The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University Luzhou China
Mianyang 404 Hospital Mianyang China
Mudanjiang First People's Hospital Mudanjiang China
The First People's Hospital of Qingzhen Qingzhen China
Yellow River Sanmenxia Hospital Sanmenxia China
Ninglin People's Hospital Shangqiu China
The First People'S Hospital of Shangqiu Shangqiu China
The People's Hospital Of An Jv Suining China
Yutian Hospital Tangshan China
Wuhan Puren Hospital Wuhan China
Zhongnan Hospital of Wuhan University Wuhan China
Xiangyang No.1 People's Hospital Xiangyang China
Yaan People's Hospital Ya'an China
Yichang Central People's Hospital Yichang China

+ 5 more sites — see the full list on the official registry below.

More Southwest Hospital, China trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07469293 on ClinicalTrials.gov ↗ ← All trials in China