Tenecteplase Thrombolytic Therapy for Acute Ischemic Stroke in China
- Registration Number
- NCT06078995
- Lead Sponsor
- Huashan Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1200
- all acute ischaemic stroke patients who met eligibility for thrombolysis with intravenous alteplase or TNK and presenting within 4·5 hours of symptom onset.
- variables with a missing rate > 40%
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Tenecteplase Tenecteplase acute ischemic stroke patients who receive intravenous thrombolysis with tenecteplase alteplase Alteplase acute ischemic stroke patients who receive intravenous thrombolysis with alteplase
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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
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.
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.
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
Trial Locations
- Locations (1)
Xin Chen
🇨🇳Shanghai, China