Status:
COMPLETED
Study to Learn More About the Safety and Effectiveness of Rivaroxaban (Xarelto) When Given Together With Acetylsalicylic Acid to Indian People With Narrowing of the Arteries of the Heart (CAD) and/or With Reduced Blood Flow in the Arteries of the Legs and Arms With Symptoms (Symptomatic PAD)
Lead Sponsor:
Bayer
Conditions:
Prevention of Atherothrombotic Events
Coronary Artery Disease (CAD)
Eligibility:
All Genders
18+ years
Brief Summary
This is an observational study in which data from Indian people with coronary artery disease and / or symptomatic peripheral artery disease who will be receiving the drug rivaroxaban (Xarelto) are stu...
Eligibility Criteria
Inclusion
- Adult (≥18 years) patient.
- Diagnosis of CAD or PAD.
- Treatment with Rivaroxaban 2.5mg tablet, co administered with acetylsalicylic acid (ASA), for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events within 4 weeks prior to enrolment. also patients already on rivaroxaban treatment for ACS, who are subsequently fulfilling criteria for CAD, are allowed to be enrolled within 4 weeks of this decision being made.
- Patients who are willing to participate in this study (signed informed consent).
Exclusion
- Contra-indications according to the local marketing authorization.
- Patients who will be treated with chronic anticoagulation therapy other than rivaroxaban 2.5mg given for CAD/PAD.
- Participation in an interventional trial.
Key Trial Info
Start Date :
February 25 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 6 2024
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04298567
Start Date
February 25 2022
End Date
June 6 2024
Last Update
June 28 2024
Active Locations (1)
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1
Many locations
Multiple Locations, India