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The primary purpose of this study is to evaluate whether treatment with oral anticoagulation or oral anticoagulation and aspirin is better than aspirin alone in cardiovascular outcomes and saphenous graft patency in patients submitted to coronary artery bypass graft.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Anticoagulation+Antiplatelet | Experimental | Rivaroxaban 2.5 mg twice daily and Aspirin 100 mg once daily. |
|
| Oral Anticoagulation | Experimental | Rivaroxaban 20 mg once daily |
|
| Antiplatet | Active Comparator | Aspirin 100 mg once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban | Drug | Rivaroxaban 2.5 mg or Rivaroxaban 20 mg or no oral anticoagulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| MACE | Time from randomization to the first occurrence of either myocardial infarction, stroke, or cardiovascular death | 5 years |
| Graft Patency | Time from randomization to the first occurence of saphenous graft oclusion | 5 years |
| Major Bleeding | Time from randomization to the first occurrence of major bleeding (modified International Society on Thrombosis and Haemostasis) | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| MACE, cardiovascular death | Time from randomization to first occurrence of either coronary heart disease death, myocardial infarction, ischemic stroke, acute limb ischemia | 5 years |
| All-cause mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luis Paiva, MD | Contact | +351917952197 | luisvpaiva@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Hospitalar e Universitário de Coimbra | Coimbra | Portugal |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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Time from randomization to first occurrence of all-cause mortality
| 5 years |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |