Tenecteplase REperfusion in Acute Ischemic sTroke Registry（TREAT）

Study Overview
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Brief Summary
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The aim of the study was to establish tenecteplase thrombolysis database and to investigate the effectiveness and safety of rhTNK-tPA in acute ischemic stroke patients.

Detailed Description
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Tenecteplase (TNK), as a newer fibrinolytic agent, has practical delivery advantages over alteplase that would make it a potential alternative. Several randomized controlled clinical trials demonstrated the noninferiority of TNK but the evidence on the effectiveness and safety of TNK in the real-world is insufficient. This is a multi-center, prospective, registry cohort study that enrolled acute ischemic stroke patients treated with TNK thrombolysis in China.

Official Title
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Tenecteplase REperfusion in Acute Ischemic sTroke Registry

Conditions
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Stroke, Ischemic

Intervention / Treatment
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* Drug: rhTNK-tPA Thrombolysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older than 18 years; Diagnosed as acute ischemic stroke； Time intervals ≤ 4.5 hours from stroke onset to thrombolysis with TNK(Perfusion imaging completed including CTA+CTP or MRA+PWI+DWI before thrombolysis if the time intervals from stroke onset to thrombolysis was ≥4.5 hours)； Thrombolysis with rhTNK-tPA and derivatives. Exclusion Criteria: Unlikely to adhere to the study protocol or follow-up ( life expectancy ≤ 3 months)； Already participated in other interventional trials.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| rhTNK-tPA Thrombolysis<br> | Drug: rhTNK-tPA Thrombolysis<br>* rhTNK-tPA Thrombolysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excellent functional outcome at 90 days | proportion of mRS score 0-1 at 3 months. The modified Rankin Scale (mRS) has a minimum value of 0 and maximum value of 6. Higher value indicated worse functional outcome | 3 months after thrombolysis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Favorable functional outcome | proportion of mRS score 0-2 at 3 months | 3 months after thrombolysis | 
| Walk independence | proportion of mRS score 0-3 at 3 months | 3 months after thrombolysis | 
| Ordinal distribution of mRS at 90 days | Number of participants with the ordinal distribution of mRS at 90 days | 3 months after thrombolysis | 
| Neurological improvement at 24 hours | NIHSS score <=1 or improvement of NIHSS score>=4 compared with baseline NIHSS. National Institution Health Stroke Scale (NIHSS) has a minimum value of 0 and maximum value of 45. Higher value indicated worse severity of neurological impairment. | 24 hours after thrombolysis | 
| NIHSS score at discharge | NIHSS score at 5-7 days or at discharge | 5-7days after thrombolysis or at discharge | 
| EQ-5D score at 90 days | EQ-5D score at 3 months. EuroQol Five Dimensions Questionnaire scale (EQ-5D score) has a minimum value of 0 and maximum value of 100. Lower value indicated worse functional outcome | 3 months after thrombolysis | 
| Barthel(BI) at 90 days | Global function of daily living defined as BI ≥ 95 at 90 days | 3 months after thrombolysis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thrombolysis, tenecteplase