Health Condition 1: I999- Unspecified disorder of circulatory system
Conditions
Interventions
Intervention1: Rivaroxaban plus antiplatelet
therapy: Tablet rivaroxaban 2.5 mg twice
daily along with aspirin (75-100
mg) once daily for 1 year of duration
Control Intervention1: Antiplatelet therapy
Sponsors
Dr Viveka Kumar
Eligibility
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide written informed consent 2. Age >18 years, either gender and known case stable coronary artery disease (CAD) 3. Patient at high risk for atherothrombosis 4. Patient eligible for dual pathway therapy (Rivaroxaban plus Aspirin) based on clinical judgement and receiving the same
Exclusion criteria
Exclusion criteria: 1. Clinically considered high risk of bleeding 2. Presence of gastrointestinal bleed 3. Stroke within 1 month or any history of hemorrhagic or lacunar stroke 4. Severe heart failure with known ejection fraction 5. Estimated glomerular filtration rate (eGFR) 6. Clinically requiring dual antiplatelet therapy, other non-aspirin antiplatelet therapy, or oral anticoagulant therapy 7. History of hypersensitivity or known contraindication for rivaroxaban, aspirin, or excipients, if applicable. 8. Systemic treatment with strong inhibitors of both CYP 3A4 and p-glycoprotein (P-gp) (e.g., systemic azole antimycotics, such as ketoconazole, and human immunodeficiency virus [HIV]-protease inhibitors, such as ritonavir), or strong inducers of CYP 3A4, i.e. rifampicin, rifabutin, phenobarbital, phenytoin, and carbamazepine. 9. Subjects who are pregnant, breastfeeding, or are of childbearing potential, and sexually active and not practicing an effective method of birth control
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage risk reduction in the risk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with CADTimepoint: 1 Year | — |
Secondary
| Measure | Time frame |
|---|---|
| The primary safety outcome will be a composite of: ï?? Fatal bleeding, and/or ï?? Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, or bleeding into the surgical site requiring re-operation, and/or ï?? Bleeding leading to hospitalization ï?? Hospitalization ï?? Adverse events Timepoint: 1 Year | — |
Countries
India
Contacts
Public ContactDr Viveka Kumar
Max Super Speciality Hospital
Outcome results
None listed