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The benefit of intravenous tenecteplase in very old patients with acute ischemic stroke (AIS) remain uncertain. This real-world study aims to evaluate the effectiveness and safety of intravenous tenecteplase in AIS patients aged 80 years or older within 4.5 hours of symptom onset.
The study is an investigator-initiated, multicenter, prospective, observational, real-world registry designed to evaluate the effectiveness and safety of intravenous tenecteplase in AIS patients aged 80 years or older within 4.5 hours of symptom onset. The primary outcome is excellent outcome, as defined by a score of 0 or 1 on modified Rankin Scale (mRS) at 90 days. The study is anticipated to enroll at least 392 participants, with no less than 196 participants in the tenecteplase group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Standard medical treatment |
| |
| Tenecteplase group | Intravenous tenecteplase thrombolysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg) | Drug | Tenecteplase is administered as a single intravenous bolus at a dose of 0.25 mg/kg, with a maximum of 25 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Excellent outcome | The proportion of modified Rankin Scale (mRS) score of 0-1 at 90 days | 90 (±14) days |
| Measure | Description | Time Frame |
|---|---|---|
| Level of disability | Ordinal shift analysis of the mRS with 5-6 merged at 90 days. | 90 (±14) days |
| Functional independence | The proportion of mRS score of 0-2 at 90 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic intracranial hemorrhage | Incidence of symptomatic intracranial hemorrhage within 36 hours from enrollment (Heidelberg criteria). | 24 (±12) hours |
| Any intracranial hemorrhage | Incidence of any intracranial hemorrhage within 36 hours from enrollment (Heidelberg classification). |
Inclusion Criteria:
Exclusion Criteria:
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This study will consecutively screen patients with acute ischemic stroke (AIS) who are over 80 years of age and arrive at the hospital within 4.5 hours of symptom onset.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dong Pan, MD, PhD | Contact | 86-156 2648 3251 | dongpan012@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuan Wu, MD, PhD | First Affiliated Hospital of Guangxi Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | 530021 | China |
Data supporting the findings of the study are available on reasonable request after approval of a proposal from the principal investigator.
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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 |
| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Standard medical care | Other | Standard medical treatment should adhere to clinical guidelines and usual care at site, including antiplatelet therapy, anticoagulant therapy, lipid-lowering therapy, antihypertensive drugs, etc., as determined by the local investigators. |
|
| 90 (±14) days |
| Early neurological improvement | The proportion of NIHSS 0-1 or ≥4 points reduction at 24 hours. | 24 (±12) hours |
| Change in stroke severity | The change of NIHSS score from enrollment to 7 days or at discharge (whichever comes first). | 7 (±1) days or at discharge |
| Quality of life measured by EQ-5D-5L | EQ-5D-5L scale score at 90 days. | 90 (±14) days |
| 24 (±12) hours |
| Extracranial bleeding | Incidence of moderate-to-severe extracranial bleeding (GUSTO criteria) within 36 hours from enrollment. | 24 (±12) hours |
| Mortality | All cause death within 90 days. | 90 days |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006867 |
| Hydrolases |
| 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 |