Study on use of rivaroxaban along with aspirin in the management of coronary heart disease problem

Not Applicable

Conditions: Health Condition 1: I999- Unspecified disorder of circulatory system

Registration Number: CTRI/2021/08/035826

Lead Sponsor: Dr Viveka Kumar

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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 <30% or New York Heart Association (NYHA) class III or IV symptoms

5.Estimated glomerular filtration rate (eGFR) <15 mL/min

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

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage risk reduction in the risk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with CADTimepoint: 1 Year

Secondary Outcome Measures

Name	Time	Method
The primary safety outcome will be a composite of: <br/ ><br>ï??Fatal bleeding, and/or <br/ ><br>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 <br/ ><br>ï??Bleeding leading to hospitalization <br/ ><br>ï??Hospitalization <br/ ><br>ï??Adverse events <br/ ><br>Timepoint: 1 Year