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| Name | Class |
|---|---|
| International Society on Thrombosis and Haemostasis | UNKNOWN |
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This registry, currently being established will ensure consistency of data collection and provide safety information in non high-risk APS patients currently on DOACs.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban | Drug | Rivaroxaban 10 mg or 15 mg or 20 mg OD Dabigatran 110 mg or 150 mg BID Apixaban 2.5 mg or 5 mg or 10 mg BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Recurrent Thrombosis | Rate of Recurrent Thrombosis either arterial, venous or microvascular confirmed by a relevant exam | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Bleeding | Rate of Bleeding either severe or major or clinically relevant non-major bleeding according to ISTH classification | 6 months |
| Rate of Non-Criteria Manifestations | Rate of Non-Criteria Manifestations according to Sydney criteria |
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Inclusion Criteria:
Exclusion Criteria:
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Thrombotic APS patients according to revised Sapporo-Sydney criteria
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Virginie Dufrost, MD, MSc | Contact | +33383157828 | v.dufrost@chru-nancy.Fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stéphane Zuily | Recruiting | Nancy | 54500 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30103045 | Background | Dufrost V, Risse J, Reshetnyak T, Satybaldyeva M, Du Y, Yan XX, Salta S, Gerotziafas G, Jing ZC, Elalamy I, Wahl D, Zuily S. Increased risk of thrombosis in antiphospholipid syndrome patients treated with direct oral anticoagulants. Results from an international patient-level data meta-analysis. Autoimmun Rev. 2018 Oct;17(10):1011-1021. doi: 10.1016/j.autrev.2018.04.009. Epub 2018 Aug 11. | |
| 28741234 |
| Label | URL |
|---|---|
| ISTH SSC LA/aPL project | View source |
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| ID | Term |
|---|---|
| D016736 | Antiphospholipid Syndrome |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D000069604 | Dabigatran |
| C522181 | apixaban |
| C552171 | edoxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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| 6 months |
| Adherence to treatment | Rate of patients who have a good adherence to oral anticoagulants assessed by the Girerd questionnaire | 6 months |
| Background |
| Dufrost V, Risse J, Wahl D, Zuily S. Direct Oral Anticoagulants Use in Antiphospholipid Syndrome: Are These Drugs an Effective and Safe Alternative to Warfarin? A Systematic Review of the Literature: Response to Comment. Curr Rheumatol Rep. 2017 Aug;19(8):52. doi: 10.1007/s11926-017-0676-2. No abstract available. |
| OBSTINATE webpage | View source |
| D002318 |
| Cardiovascular Diseases |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |