Tenecteplase Thrombolytic Therapy for Acute Ischemic Stroke in China

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to investigate the effectiveness and safety of rhTNK-tPA in acute ischemic stroke patients within 4.5 hours of symptom onset in a real-world clinical setting.

Detailed Description
-----------------
Recombinant human tenecteplase tissue-type plasminogen activator (rhTNK-tPA) has the logistic advantage of a single bolus infusion over recombinant tissue plasminogen activator (rt-PA) which needs a 1-hour infusion. The non-inferiority of rhTNK-tPA compared to rt-PA was proved by two recent randomized controlled clinical trials but the evidence is lacking regarding the real-world effectiveness and safety of rhTNK-tPA. This is a multi-center, observational, retrospective study that enrolled acute ischemic stroke patients treated with rhTNK-tPA thrombolysis in China.

Official Title
-----------------
Tenecteplase Thrombolytic Therapy for Acute Ischemic Stroke in China a Real-world, Multicenter, Retrospective, Controlled Study

Conditions
-----------------
Ischemic Stroke

Intervention / Treatment
-----------------
* Drug: Tenecteplase
* Drug: Alteplase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all acute ischaemic stroke patients who met eligibility for thrombolysis with intravenous alteplase or TNK and presenting within 4·5 hours of symptom onset. Exclusion Criteria: variables with a missing rate > 40%
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tenecteplase<br>acute ischemic stroke patients who receive intravenous thrombolysis with tenecteplase | Drug: Tenecteplase<br>* Thrombolysis wtih rhTNK-tPA<br>* Other names: rhTNK-tPA;|
| alteplase<br>acute ischemic stroke patients who receive intravenous thrombolysis with alteplase | Drug: Alteplase<br>* Thrombolysis wtih rt-PA<br>* Other names: rt-PA;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients with symptomatic intracranial hemorrhage within 36 hours | Clinical deterioration or neurological decline causing an increase in NIHSS score of ≥4 points due to intracranial hemorrhage confirmed by brain imaging | 36 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90 days mRS 0-1 | modified Rankin Scale score measures degree of disability/dependence after a stroke. Patients are graded on the scale of 0-6, with higher scores indicating worse functional outcome. 0 means no symptoms, 6 means death. | at 90±7 days | 
| 90 days mRS shift | a shift analysis of the distribution of modified Rankin Scale score which measures degree of disability/dependence after a stroke. Patients are graded on the scale of 0-6, with higher scores indicating worse functional outcome. 0 means no symptoms, 6 means death. | at 90±7 days | 
| discharge mRS | modified Rankin Scale score measures degree of disability/dependence after a stroke. Patients are graded on the scale of 0-6, with higher scores indicating worse functional outcome. 0 means no symptoms, 6 means death. | at discharge (up to 30 days) | 
| 24 hours NIHSS score | The NIH Stroke Scale/Score (NIHSS) quantifies stroke severity based on weighted evaluation findings. Scores range from 0 to 42, with higher scores indicating greater severity. | at 24 hours after receiving thrombolysis | 
| discharge NIHSS score | The NIH Stroke Scale/Score (NIHSS) quantifies stroke severity based on weighted evaluation findings. Scores range from 0 to 42, with higher scores indicating greater severity. | at discharge (up to 30 days) | 
| Rate of patients with any systematic bleeding | Rate of patients with any systematic bleeding requiring blood infusion during hospital stay reflecting short term safety outcome | during hospital stay (up to 30 days) | 
| Rate of patients with 90 days mortality | Rate of patients with all-cause mortality within 90 days reflecting safety outcome | at 90±7 days | 
| Rate of patients with any intracranial hemorrhage | Rate of patients with any intracranial hemorrhage without significant neurological deterioration on the brain imaging reflecting short term safety outcome | during hospital stay (up to 30 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intravenous thrombolysis, Tenecteplase