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| Name | Class |
|---|---|
| Keshiketeng Banner Traditional Chinese Medicine Mongolian Medicine Hospitalorem Ipsum | UNKNOWN |
| Nanshi Hospital of Nanyang | UNKNOWN |
| First Affiliated Hospital of Ningbo University | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenecteplase | acute ischemic stroke patients who receive intravenous thrombolysis with tenecteplase |
| |
| alteplase | acute ischemic stroke patients who receive intravenous thrombolysis with alteplase |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenecteplase | Drug | Thrombolysis wtih rhTNK-tPA |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate 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 | 36 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 90±7 days |
| 90 days mRS shift |
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Inclusion Criteria:
Exclusion Criteria:
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acute ischemic stroke patients treated with rhTNK-tPA or rt-PA in China.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiang Dong, M.D. Ph.D. | Contact | 86-021-52887142 | qiang_dong163@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Qiang Dong | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xin Chen | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077785 | Tenecteplase |
| D010959 | Tissue Plasminogen Activator |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| Jilin Liuhe Hospital | UNKNOWN |
| Shenyang Fifth People's hospital | UNKNOWN |
| Shanghai East Hospita | UNKNOWN |
| Shanghai 10th People's Hospital | OTHER |
| Shanghai Fifth People's Hospital | UNKNOWN |
| Shanghai Pudong Gongli hospital | UNKNOWN |
| Shanghai Neuromedical Center | UNKNOWN |
| Shanghai Fourth People's Hospital | UNKNOWN |
| Shanghai Pudong People's Hospital | UNKNOWN |
| Shanghai Putuo District Center Hospital | OTHER |
| Shenyang Fushun general hospital of mining bureau | UNKNOWN |
| Yantai Affliated Hosiptal of Binzhou Medical University | UNKNOWN |
| Shanghai Ninth People's Hospital Huangpu Branch | UNKNOWN |
| Shanghai Deji Hospital | UNKNOWN |
| Ruijin Hospital Luwan Branch | OTHER |
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| Alteplase | Drug | Thrombolysis wtih rt-PA |
|
|
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. |
| 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. | 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. | 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. | 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 | 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 | 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 | during hospital stay (up to 30 days) |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |