The EXTEND-TNK Registry is a prospective, multicenter, observational cohort study designed to evaluate the effectiveness and safety of intravenous tenecteplase administered beyond 4.5 hours after last known well in patients with acute ischemic stroke (AIS) in routine clinical practice across China.
This prospective, multicenter, observational cohort registry enrolls adult patients (≥18 years) with acute ischemic stroke who receive intravenous tenecteplase more than 4.5 hours after last known well. Patient selection, imaging strategies, thrombolytic dosing, and concomitant therapies are determined by treating physicians according to local clinical practice, without study-mandated intervention. The primary outcome is the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-1 at 90±14 days. This registry describes real-world patient characteristics, treatment patterns, and outcomes of extended time window intravenous tenecteplase, and explores factors associated with clinical outcomes to inform patient selection and future clinical practice.
Study Type
OBSERVATIONAL
Enrollment
3,000
Intravenous tenecteplase 0.25 mg/kg (maximum 25 mg) administered as a single IV bolus over 5-10 seconds. In this observational cohort, tenecteplase is the only thrombolytic agent included and there is no active comparator.
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Liuyang Jili Hospital
Guankou, Hunan, China
The modified Rankin Scale score (mRS) 0-1
The proportion of mRS score 0-1 or a return to baseline if the pre-stroke mRS score ≥2 at 90±14 days. The modified Rankin Scale is a 7-point ordinal scale ranging from 0 to 6, with higher scores indicating greater disability (0 = no symptoms; 6 = death).
Time frame: 90±14 days
Level of disability
The shift analysis of the mRS scores at 90±14 days. The modified Rankin Scale is a 7-point ordinal scale ranging from 0 to 6, with higher scores indicating greater disability (0 = no symptoms; 6 = death).
Time frame: 90±14 days
The modified Rankin Scale score (mRS) 0-2
The proportion of mRS score 0-2 at 90±14 days
Time frame: 90±14 days
The modified Rankin Scale score (mRS) 0-3
The proportion of mRS score 0-3 at 90±14 days
Time frame: 90±14 days
Change in neurologic deficit (NIHSS score) at 24 hours
Change in neurologic deficit (NIHSS score) from baseline to 24±12 hours after intravenous thrombolysis. The National Institutes of Health Stroke Scale (NIHSS) ranges from 0 to 42, with higher scores indicating more severe neurologic deficit.
Time frame: 24±12 hours
Change in neurologic deficit (NIHSS score) at 7 days or discharge
Change in neurologic deficit (NIHSS score) from baseline to 7 ± 1 days or at discharge, if earlier. The National Institutes of Health Stroke Scale (NIHSS) ranges from 0 to 42, with higher scores indicating more severe neurologic deficit.
Time frame: 7±1 days
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The modified Rankin Scale score (mRS) 0-1 at 1 year
The proportion of mRS score 0-1 at 1 year ± 60 days
Time frame: 1 year ± 60 days
Stroke recurrence within 90 days
Stroke recurrence and time to recurrence within 90 days
Time frame: 90±14 days
Stroke recurrence within 1 year
Stroke recurrence and time to recurrence within 1 year
Time frame: 1 year ± 60 days