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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extended time window intravenous tenecteplase |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenecteplase | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 90±14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 90±14 days |
| The modified Rankin Scale score (mRS) 0-2 |
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic intracranial hemorrhage | Rate of symptomatic intracranial hemorrhage within 36 hours after intravenous thrombolysis (European Cooperative Acute Stroke Study [ECASS] III classification) | 36 hours |
| Any intracranial hemorrhage |
Inclusion Criteria:
Exclusion Criteria:
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Adult patients (≥18 years) with acute ischemic stroke who receive intravenous tenecteplase more than 4.5 hours after last known well as part of standard clinical care.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingyi Bao | Contact | 86-20-81332619 | baomy@mail2.sysu.edu.cn | |
| Xinguang Yang | Contact | yangxinguang0926@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yamei Tang | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Principal Investigator |
| Yong He | Liuyang Jili Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | China | |||
| Liuyang Jili Hospital |
The IPD will be available from the Principal Investigators (Prof. Yamei Tang and Prof. Yong He) upon reasonable request.
6 months after the trial completion.
The IPD will be available from the Principal Investigators (Prof. Yamei Tang and Prof. Yong He) upon reasonable request.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077785 | Tenecteplase |
| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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The proportion of mRS score 0-2 at 90±14 days |
| 90±14 days |
| The modified Rankin Scale score (mRS) 0-3 | The proportion of mRS score 0-3 at 90±14 days | 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. | 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. | 7±1 days |
| The modified Rankin Scale score (mRS) 0-1 at 1 year | The proportion of mRS score 0-1 at 1 year ± 60 days | 1 year ± 60 days |
| Stroke recurrence within 90 days | Stroke recurrence and time to recurrence within 90 days | 90±14 days |
| Stroke recurrence within 1 year | Stroke recurrence and time to recurrence within 1 year | 1 year ± 60 days |
Rate of any intracranial hemorrhage within 36 hours after intravenous thrombolysis
| 36 hours |
| Serious adverse events during hospitalization | Safety will be assessed according to common terminology criteria for adverse events (CTCAE) | 7±1 days |
| Mortality within 90 days | All-cause mortality within 90 days | 90±14 days |
| Mortality within 1 year | All-cause mortality within 1 year | 1 year ± 60 days |
| Guankou |
| Hunan |
| China |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |