Ischemic Stroke
Conditions
Keywords
intravenous thrombolysis, Tenecteplase
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.
Interventions
DRUGTenecteplase
Thrombolysis wtih rhTNK-tPA
DRUGAlteplase
Thrombolysis wtih rt-PA
Sponsors
Keshiketeng Banner Traditional Chinese Medicine Mongolian Medicine Hospitalorem Ipsum
Nanshi Hospital of Nanyang
First Affiliated Hospital of Ningbo University
Jilin Liuhe Hospital
Shenyang Fifth People's hospital
Shanghai East Hospita
Shanghai 10th People's Hospital
Shanghai Fifth People's Hospital
Shanghai Pudong Gongli hospital
Shanghai Neuromedical Center
Shanghai Fourth People's Hospital
Shanghai Pudong People's Hospital
Shanghai Putuo District Center Hospital
Shenyang Fushun general hospital of mining bureau
Yantai Affliated Hosiptal of Binzhou Medical University
Shanghai Ninth People's Hospital Huangpu Branch
Shanghai Deji Hospital
Ruijin Hospital Luwan Branch
Huashan Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of patients with symptomatic intracranial hemorrhage within 36 hours | 36 hours | Clinical deterioration or neurological decline causing an increase in NIHSS score of ≥4 points due to intracranial hemorrhage confirmed by brain imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 90 days mRS shift | at 90±7 days | 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. |
| discharge mRS | at discharge (up to 30 days) | 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. |
| 24 hours NIHSS score | at 24 hours after receiving thrombolysis | 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. |
| 90 days mRS 0-1 | at 90±7 days | 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. |
| Rate of patients with any systematic bleeding | during hospital stay (up to 30 days) | Rate of patients with any systematic bleeding requiring blood infusion during hospital stay reflecting short term safety outcome |
| Rate of patients with 90 days mortality | at 90±7 days | Rate of patients with all-cause mortality within 90 days reflecting safety outcome |
| Rate of patients with any intracranial hemorrhage | during hospital stay (up to 30 days) | Rate of patients with any intracranial hemorrhage without significant neurological deterioration on the brain imaging reflecting short term safety outcome |
| discharge NIHSS score | at discharge (up to 30 days) | 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. |
Countries
China
Contacts
Primary ContactQiang Dong, M.D. Ph.D.
Outcome results
None listed