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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TNK intra-arterial thrombolysis group | Experimental | Intra-arterial thrombolysis |
|
| Standard medical therapy group | Active Comparator | Only standard medical therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-arterial thrombolysis | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At Day 90±7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xianhua Hou | Contact | 86-13594020663 | houxianhua@tmmu.edu.cn | |
| Lin Chen | Contact | 86-18602300737 | 406019975@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Youjiang Medical University for Nationalities | Baise City | Guangxi | China | |||
The IPD will be available from the Principal Investigator upon reasonable request 6 months after the trial completion.
6 months after the trial completion.
The IPD will be available from the Principal Investigator upon reasonable request 6 months after the trial completion.
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multicenter, prospective, randomized, open label, blinded-endpoint (PROBE)
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| Standard medical treatment | Other | Standard medical treatment |
|
| 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 | 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). | 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). | 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) | At Day 90±7 days |
| All-cause mortality | All-cause mortality at 90 days | up to 90 days |
| Guilin People'S Hospital |
| Guilin |
| Guangxi |
| China |
|
| The People's Hospital Of QianNan | Qiannan | Guizhou | China |
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| Chongzhou People's Hospital | Chengdu | Sichuan | China |
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| Dali Nationality Autonomous Prefecture Hospital | Dali | Yunnan | China |
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| Qujing Central Hospital of Yunnan Province | Qujing | Yunnan | China |
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| Ankang Central Hospital | Ankang | China |
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| The People'S Hospital of Anyang City | Anyang | China |
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| Changchun Central Hospital | Changchun | China |
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| Chengdu Second People's Hospital | Chengdu | China |
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| Chonggang General Hospital | Chongqing | China |
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| Chongqing University Fuling Hospital | Chongqing | China |
| Jiangjin Central Hospital | Chongqing | China |
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| 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 |
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| Guangyuan Central Hospital | Guangyuan | China |
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| Qiandongnan Prefecture People's Hospital | Guizhou | China |
|
| Huaibei Miners General Hospital | Huaibei | China |
|
| The People's Hospital of Jianyang City | Jianyang | China |
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| 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 |
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| Yiyang County People'S Hospital | Luoyang | China |
|
| The Affiliated Hospital of Southwest Medical University | Luzhou | China |
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| 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 |
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| Yutian Hospital | Tangshan | China |
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| Wuhan Puren Hospital | Wuhan | China |
| Zhongnan Hospital of Wuhan University | Wuhan | China |
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| Xiangyang No.1 People's Hospital | Xiangyang | China |
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| Yaan People's Hospital | Ya'an | China |
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| Yichang Central People's Hospital | Yichang | China |
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| Zhengzhou Central Hospital | Zhengzhou | China |
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| Zhoukou Central Hospital | Zhoukou | China |
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| Zhumadian Central Hospital | Zhumadian | China |
| Zhuzhou Central Hospital | Zhuzhou | China |
| Zigong Third People's Hospital | Zigong | China |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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