Health Condition 1: I259- Chronic ischemic heart disease, unspecified
Conditions
Interventions
Intervention1: Rivaroxaban plus antiplatelet therapy: Tablet rivaroxaban 2.5 mg oral twice daily along with aspirin (75-100 mg) oral once daily for 1 year
Control Intervention1: NIL: NIL
Control Inte
Sponsors
Emcure Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >18 years, either gender having a diagnosis of coronary artery disease and meeting the following additional criteria a. Taking antiplatelet therapy for coronary artery disease or peripheral artery disease b. Having �2 vascular beds affected or eligible to take an oral anticoagulant therapy 2. Willing to provide written informed consent and for follow up of one year from the date of registration.
Exclusion criteria
Exclusion criteria: 1. Patients having a diagnosis of atrial fibrillation (valvular or non-valvular) prior to or at the time of index acute coronary event or diagnosis. 2. Patients on high doses of newer oral anticoagulants - ââ?°Â¥10mg per day. 3. Patients on vitamin K antagonist for any reason. 4. Patients not likely to cooperate for data collection and follow up ââ?¬â?? investigatorââ?¬•s decision.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of net clinical benefit between rivaroxaban with antiplatelet therapy group and antiplatelet therapy alone group. Net Clinical Benefit will be a composite of effectiveness (reduction in incidence of cardiovascular death, stroke, MI) and safety (life threatening or fatal bleeding)Timepoint: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in quality of life from baseline to 1 year assessed using SF-36 questionnaire.Timepoint: 1 year;Effectiveness of rivaroxaban with antiplatelet therapy vs antiplatelet therapy alone in reducing the compose outcomes (stroke, myocardial infarction, cardiovascular death)Timepoint: 1 year;Incidence of major bleeding between rivaroxaban with antiplatelet therapy vs antiplatelet therapy aloneTimepoint: 1 year;Net clinical benefit will be compared between the 2 groups (rivaroxaban with antiplatelet therapyvs antiplatelet therapy alone) based on age group (less than 65 years vs more than 65 years); prior PCI, presence,or absence of comorbidities such as heart failure, diabetes mellitus, MI.Timepoint: 1 year;Non inferiorityof rivaroxaban (Exafib) vs rivaroxaban (reference drug) on net clinical benefitTimepoint: 1 year | — |
Countries
India
Contacts
Public ContactDr Dhammadeep Dabhade
Emcure Pharmaceuticals Limited
Outcome results
None listed