Acute Ischemic StrokePhase 3NCT07469293
Efficacy and Safety of Intra-arterial Tenecteplase in Acute Ischemic Stroke Patients With Medium Vessel Occlusion Stroke (DATE-MeVO)
A Phase 3 study testing Intra-arterial thrombolysis and Standard medical treatment in people with Acute Ischemic Stroke, run by Southwest Hospital, China at 45 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Intra-arterial thrombolysis and Standard medical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 488 participants
- Where
- 45 sitesChina
- Study dates
- 25 Mar 2026to 31 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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
Trial locations and contacts
45 sites in 1 country. Contact the study team or a site near you to ask about taking part.
45 sites in 1 country
China45 sites
Ankang Central Hospital
Ankang
Chu Xingjv, +86 15319843133
The People'S Hospital of Anyang City
Anyang
Zhang Jiangang
Affiliated Hospital of Youjiang Medical University for Nationalities
Baise City, Guangxi
Changchun Central Hospital
Changchun
Wang Lesheng, +86 13596227220
Chongzhou People's Hospital
Chengdu, Sichuan
Wu Youlin, +86 18628172896
Chengdu Second People's Hospital
Chengdu
Wu Changchuan, +86 15388151282
Chonggang General Hospital
Chongqing
Ding Chawen, +86 17764830950
Chongqing University Fuling Hospital
Chongqing
Jiangjin Central Hospital
Chongqing
Zhang Zuowen, +86 15823472901
The Ninth People'S Hospital of Chongqing
Chongqing
Huang Shuchun, +86 18708533468
The Thrid Affiliated Hospital of CQMU
Chongqing
Cheng Saiyu, +86 13527598096
Yunyang County People'S Hospital
Chongqing
Cai Tieying, +86 13896311415
Dali Nationality Autonomous Prefecture Hospital
Dali, Yunnan
Han Shibo, +86 18908722303
The First Affiliated Hospital of Fujian Medicaluniversity
Fuzhou
Zhao Wenlong, +86 18060893376
Guangyuan Central Hospital
Guangyuan
Pu Tianqiang, +86 18227306608
Guilin People'S Hospital
Guilin, Guangxi
Pan Honghua, +86 18978337949
Qiandongnan Prefecture People's Hospital
Guizhou
Shen Jian, +86 15985527337
Huaibei Miners General Hospital
Huaibei
Ma Xinan, +86 15805619166
The People's Hospital of Jianyang City
Jianyang
Tang Jie, +86 15123825598
The 960th Hospital of the PLA Joint Logistics Support Force
Jinan
Luoyang Mengjin People's Hospital
Luoyang
Zhao Haojin, +86 18937982836
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang
Shen Ruile, +86 15703790088
Yiyang County People'S Hospital
Luoyang
Zhao Jingjing, +86 18103797861
The Affiliated Hospital of Southwest Medical University
Luzhou
Yuan Zhengzhou, +86 18111209050
The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University
Luzhou
Guo Zhaoyun, +86 13440011005
Mianyang 404 Hospital
Mianyang
Luo Jun, +86 13518319060
Mudanjiang First People's Hospital
Mudanjiang
Yu Pengfei, +86 13604609208
The People's Hospital Of QianNan
Qiannan, Guizhou
Jiang Maojun, +86 15185516184
The First People's Hospital of Qingzhen
Qingzhen
Fu Hang, +86 15338501820
Qujing Central Hospital of Yunnan Province
Qujing, Yunnan
Chen Boyu, +86 18064858755
Yellow River Sanmenxia Hospital
Sanmenxia
Wu Xiaofeng, +86 13639893979
Ninglin People's Hospital
Shangqiu
Ju Zhixiang
The First People'S Hospital of Shangqiu
Shangqiu
The People's Hospital Of An Jv
Suining
Liao Jiasheng, +86 18398444888
Yutian Hospital
Tangshan
Li Haijun, +86 13111464171
Wuhan Puren Hospital
Wuhan
Zhongnan Hospital of Wuhan University
Wuhan
Mei Bin, +86 13037196699
Xiangyang No.1 People's Hospital
Xiangyang
Zhou Peiyang, +86 13597491119
Yaan People's Hospital
Ya'an
Wang Jian, +86 13550064528
Yichang Central People's Hospital
Yichang
Zhou Jinghua, +86 15971663190
Zhengzhou Central Hospital
Zhengzhou
Zhou You, +86 15713891958
Zhoukou Central Hospital
Zhoukou
Li Shuai, +86 18595389709
Zhumadian Central Hospital
Zhumadian
Zhuzhou Central Hospital
Zhuzhou
Zigong Third People's Hospital
Zigong
About this study
Official title: 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
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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Intra-arterial thrombolysis, Standard medical treatment
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-arterial thrombolysisProcedure or surgery
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 treatmentOther
Standard medical treatment
| Study group | Role | What they receive |
|---|---|---|
| TNK intra-arterial thrombolysis group | Experimental | Intra-arterial thrombolysis Receives: Procedure: Intra-arterial thrombolysis |
| Standard medical therapy group | Active comparator | Only standard medical therapy Receives: Other: Standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Modified Rankin Scale (mRS) Score of 0 or 1
Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death).
Measured: At Day 90±7 days
Secondary outcomes (6)
Percentage of Participants With Symptomatic Intracerebral Haemorrhage (sICH)
sICH via criteria adapted from the European Cooperative Acute Stroke Study (ECASS III), defined as any apparent extravascular blood in the brain or within the cranium that is associated with clinical deterioration defined by an NIHSS score increase of four points or more from baseline.
Measured: up to 48 hours
Improvement in NIHSS between baseline and 5-7 days
National Institutes of Health Stroke Scale (NIHSS) is a 11-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 6 grades with 0 as normal, and there is an allowance for untestable items.Total NIHSS score (0-42) = sum of 11 individual item scores, higher total scores meaning more severe deficits
Measured: at 5-7 days from randomization
Distribution of Modified Rankin Scale (mRS)
Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death).
Measured: At Day 90±7 days
Percentage of Participants With Modified Rankin Scale (mRS) Score of 0-2
Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death).
Measured: At Day 90±7 days
EQ-5D-5L score
Health-related quality of life (the score on the EuroQol Group 5-Dimension 5-Level [EQ-5D-5L] questionnaire, range,-0.39 to 1, with higher scores indicating better quality of life)
Measured: At Day 90±7 days
All-cause mortality
All-cause mortality at 90 days
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start25 Mar 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicenter, prospective, randomized, open label, blinded-endpoint (PROBE)
- Masking
- None (open label)
- Enrolment
- 488 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenhua Zhou, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469293
- Sponsor's protocol ID
- 2025.8.10V1.0
- Status last verified
- Mar 2026
- First submitted
- 9 Feb 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will be available from the Principal Investigator upon reasonable request 6 months after the trial completion.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07469293
- Acronym / sponsor ID
- 2025.8.10V1.0
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 488 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- 25 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- multicenter, prospective, randomized, open label, blinded-endpoint (PROBE)
| Arm | Type | Receives |
|---|---|---|
| TNK intra-arterial thrombolysis group | Experimental | Procedure: Intra-arterial thrombolysisIntra-arterial thrombolysis |
| Standard medical therapy group | Active comparator | Other: Standard medical treatmentOnly standard medical therapy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-arterial thrombolysisA 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. | Procedure or surgery | TNK intra-arterial thrombolysis group |
| Standard medical treatmentStandard medical treatment | Other | Standard medical therapy group |
Primary outcome
Percentage of Participants With Modified Rankin Scale (mRS) Score of 0 or 1
Time frame: At Day 90±7 days
Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death).
6 secondary outcomes
Percentage of Participants With Symptomatic Intracerebral Haemorrhage (sICH)
Time frame: up to 48 hours
Improvement in NIHSS between baseline and 5-7 days
Time frame: at 5-7 days from randomization
Distribution of Modified Rankin Scale (mRS)
Time frame: At Day 90±7 days
Percentage of Participants With Modified Rankin Scale (mRS) Score of 0-2
Time frame: At Day 90±7 days
EQ-5D-5L score
Time frame: At Day 90±7 days
All-cause mortality
Time frame: up to 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: Yes. The IPD will be available from the Principal Investigator upon reasonable request 6 months after the trial completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intra-arterial thrombolysis and Standard medical treatment in people with Acute Ischemic Stroke, run by Southwest Hospital, China at 45 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xianhua Hou (86-13594020663, houxianhua@tmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Modified Rankin Scale (mRS) Score of 0 or 1 (time frame: At Day 90±7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.