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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Nova Scotia Health Authority | OTHER |
| Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network | NETWORK |
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Consented patients undergoing elective total hip and total knee arthroplasty will be randomized to receive either aspirin alone or aspirin and rivaroxaban for prevention of venous thromboembolism.
Aspirin and rivaroxaban prevent venous thromboembolism (VTE) via different mechanisms. Aspirin is significantly cheaper than rivaroxaban. Aspirin in combination with rivaroxaban was shown to be safe and efficacious in a non-inferiority trial (EPCATII) when compared to rivaroxaban alone.
This study will assess if aspirin alone is non-inferior to rivaroxaban and aspirin in the prevention of venous thromboembolism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THA-control arm | Active Comparator | Total Hip Arthroplasty: 5 days of rivaroxaban, followed by 30 days of aspirin |
|
| THA-study arm | Experimental | Total Hip Arthroplasty: 35 days of aspirin |
|
| TKA-control arm | Active Comparator | Total Knee Arthroplasty: 5 days of rivaroxaban, followed by 9 days of aspirin |
|
| TKA-study arm | Experimental | Total Knee Arthroplasty: 14 days of aspirin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban 10 MG and acetylsalicylic acid 81 mg | Drug | Starting post op, rivaroxaban (5 days) followed by aspirin (9 days for TKA; 30 days for THA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Venous thromboembolism | symptomatic proximal deep vein thrombosis or pulmonary embolism | 90 days |
| Bleeding | major and clinically relevant, non-major bleeds | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | all cause death | 90 days |
| Cost-effectiveness | quantitatively describe the costs of symptomatic thromboembolism events and major bleeding episodes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sudeep P Shivakumar, MD | Dalhousie University/Nova Scotia Health Authority | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Elizabeth II HSC | Halifax | Nova Scotia | B3H 3A7 | Canada |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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randomized, controlled, double-blind
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over-encapsulated rivaroxaban/ASA
|
| acetylsalicylic acid 81 mg | Drug | Starting post op, aspirin for 9 days for TKA and 30 days for THA |
|
|
| 90 days |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |