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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
488
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
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).
Time frame: At Day 90±7 days
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.
Time frame: 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
Time frame: 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).
Time frame: 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).
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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
...and 35 more locations
Time frame: 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)
Time frame: At Day 90±7 days
All-cause mortality
All-cause mortality at 90 days
Time frame: up to 90 days