TTT-AIS CHINA: Tenecteplase Thrombolytic Therapy for Acute Ischemic Stroke in China
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Tenecteplase acute ischemic stroke patients who receive intravenous thrombolysis with tenecteplase |
Drug: Tenecteplase
Thrombolysis wtih rhTNK-tPA
Other Names:
|
| alteplase acute ischemic stroke patients who receive intravenous thrombolysis with alteplase |
Drug: Alteplase
Thrombolysis wtih rt-PA
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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.
- 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.
- 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
Eligibility Criteria
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%
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Xin Chen | Shanghai | China |
Sponsors and Collaborators
- Huashan Hospital
- Keshiketeng Banner Traditional Chinese Medicine Mongolian Medicine Hospitalorem Ipsum
- Nanshi Hospital of Nanyang
- The 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 Liqun 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
Investigators
- Principal Investigator: Qiang Dong, Huashan Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20230726