Coronary Artery Disease, Saphenous Vein Graft Patency
Conditions
Brief summary
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.
Interventions
DRUGRivaroxaban
Rivaroxaban 2.5 mg or Rivaroxaban 20 mg or no oral anticoagulation
Sponsors
Unidade Local de Saúde de Coimbra, EPE
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients referred to coronary artery bypass graft and at least one saphenous vein graft
Exclusion criteria
* Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy or oral anticoagulant therapy * Stroke within 1 month or any history of hemorrhagic or lacunar stroke * Estimated glomerular filtration rate (eGFR)\<15 mL/min
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACE | 5 years | Time from randomization to the first occurrence of either myocardial infarction, stroke, or cardiovascular death |
| Graft Patency | 5 years | Time from randomization to the first occurence of saphenous graft oclusion |
| Major Bleeding | 5 years | Time from randomization to the first occurrence of major bleeding (modified International Society on Thrombosis and Haemostasis) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MACE, cardiovascular death | 5 years | Time from randomization to first occurrence of either coronary heart disease death, myocardial infarction, ischemic stroke, acute limb ischemia |
| All-cause mortality | 5 years | Time from randomization to first occurrence of all-cause mortality |
Countries
Portugal
Contacts
Primary ContactLuis Paiva, MD
Outcome results
None listed