The DATE-AGING study is a prospective, multicenter, randomized controlled trial investigating low-dose tenecteplase in elderly patients with acute ischemic stroke. Its primary objective is to evaluate the safety and efficacy of low-dose tenecteplase in elderly patients within 4.5 hours of acute ischemic stroke onset.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
798
Subjects will be randomized to low-dose group or standard-dose group in a 1:1 ratio. Patients in the low-dose group received tenecteplase (0.175 mg/kg) for intravenous thrombolysis. The upper dose limit is set to 17.5 mg/patient.
Subjects will be randomized to low-dose group or standard-dose group in a 1:1 ratio. Patients in the standard-dose group received tenecteplase (0.25 mg/kg) for intravenous thrombolysis. The upper dose limit is set to 25 mg/patient.
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 major neurological improvement (National Institutes of Health Stroke Scale (NIHSS) score of 0 or improvement of at least 4 points compared with baseline)
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 24 hours
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).
Time frame: At Day 90±7 days
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 Barthel Index Score ≥95
The Barthel Index is an ordinal scale used to measure performance in activities of daily living (ADL). The Barthel Index consists of 10 items. The total score of the Barthel Index ranges from 0 to 100, and higher scores indicate better outcome.
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Southwest Hospital, Chongqing, China
Chongqing, Chongqing Municipality, China
RECRUITINGAnshan Changda Hospital
Anshan, China
NOT_YET_RECRUITINGAnyang People's Hospital
Anyang, China
RECRUITINGHuaxian People's Hospital of Henan
Anyang, China
RECRUITINGBaoshan People's Hospital
Baoshan, China
NOT_YET_RECRUITINGPeople's Hospital of Zhijin County
Bijie, China
NOT_YET_RECRUITINGBishan Hospital
Chongqing, China
NOT_YET_RECRUITINGChongqing Emergency Medical Center
Chongqing, China
NOT_YET_RECRUITINGChongqing University Fuling Hospital
Chongqing, China
RECRUITINGChongqing University Jiangjin Hospital
Chongqing, China
RECRUITING...and 36 more locations
Time frame: up to 90 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
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 36 hours
All-cause mortality
All-cause mortality at 90 days
Time frame: up to 90 days
Percentage of Participants With Modified Rankin Scale (mRS) Score of 5 or 6
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