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| ID | Type | Description | Link |
|---|---|---|---|
| UMIN000009376 | Other Identifier | UMIN |
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The efficacy and safety of a novel oral Xa inhibitor for stroke and systemic embolism, namely rivaroxaban, in non-valvular atrial fibrillation patients are evaluated in Japanese clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-valvular atrial fibrillation |
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| Measure | Description | Time Frame |
|---|---|---|
| Combinations of symptomatic stroke (ischemic or hemorrhagic) and systemic embolism | Primary efficacy endpoint | up to March/2016 |
| Clinically significant hemorrhagic events (massive hemorrhage in accordance with the ISTH classification) | Primary safety endpoint | up to March/2016 |
| Measure | Description | Time Frame |
|---|---|---|
| Combinations of symptomatic stroke (ischemic or hemorrhagic), systemic embolism, myocardial infarction and cardiovascular death | Secondary efficacy endpoints | up to March/2016 |
| Symptomatic ischemic stroke |
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Inclusion Criteria:
Patients who meet all the criteria below
Exclusion Criteria:
Patients who meet any of the criteria below
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Non-valvular atrial fibrillation (In the present study, non-valvular atrial fibrillation refers to atrial fibrillation without a history of prosthetic valve replacement or mitral valve stenosis.)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Koji Fukuda, M.D., Ph. D | Contact | +81-22-717-7153 | fukuda@cardio.med.tohoku.ac.jp |
| Name | Affiliation | Role |
|---|---|---|
| Hiroaki Shimokawa, MD, PhD | Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine | Recruiting | Sendai | Miyagi | 980-6574 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37619876 | Derived | Shimizu W, Uchiyama S, Atarashi H, Inoue H, Kitazono T, Yamashita T, Ikeda T, Kamouchi M, Kaikita K, Fukuda K, Origasa H, Shimokawa H. Effectiveness and safety of reduced-dose rivaroxaban for elderly patients with non-valvular atrial fibrillation: A subanalysis of the EXPAND study. Int J Cardiol. 2023 Nov 15;391:131290. doi: 10.1016/j.ijcard.2023.131290. Epub 2023 Aug 22. |
| Label | URL |
|---|---|
| EXPAND study home page | View source |
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Secondary efficacy endpoints
| up to March/2016 |
| Symptomatic hemorrhagic stroke | Secondary efficacy endpoints | up to March/2016 |
| Systemic embolism | Secondary efficacy endpoints | up to March/2016 |
| Acute myocardial infarction/unstable angina pectoris | Secondary efficacy endpoints | up to March/2016 |
| Cardiovascular death | Secondary efficacy endpoints | up to March/2016 |
| Deep vein thrombosis/pulmonary thromboembolism | Secondary efficacy endpoints | up to March/2016 |
| Transient ischemic attack | Secondary efficacy endpoints | up to March/2016 |
| Interventional/surgical treatment | Secondary efficacy endpoints | up to March/2016 |
| All-cause death | Secondary efficacy endpoints | up to March/2016 |
| Clinically insignificant hemorrhagic events (hemorrhagic events other than clinically significant hemorrhagic events) | Secondary safety endpoint | up to March/2016 |