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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,200
Thrombolysis wtih rhTNK-tPA
Thrombolysis wtih rt-PA
Xin Chen
Shanghai, China
RECRUITINGRate 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
Time frame: 36 hours
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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
Time frame: 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
Time frame: 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
Time frame: during hospital stay (up to 30 days)