NCT04298567

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)

A Phase IV Study to Investigate the Safety and Effectiveness of Rivaroxaban(Xarelto) 2.5mg [BID]+Acetylsalicylic Acid(ASA) 75mg [OD] in Indian Patients With Coronary and/or Symptomatic Peripheral Artery Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 300 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 studied. Coronary artery disease (CAD) is a condition where the arteries that bring blood and oxygen to the heart become hardened and narrow. Peripheral artery disease (PAD) is a condition with reduced blood flow in the arteries of the legs and arms. People with CAD and / or PAD with symptoms may receive rivaroxaban from their doctors to prevent problems (for example, stoke) caused by blood clots and hardening of the arteries. In this study researcher want to gather more information on the safety and the effectiveness of rivaroxaban when given together with the drug acetylsalicylic acid (also known as "aspirin") to people with CAD and / or PAD with symptoms in the routine practice in India. Researchers are especially interested whether patients under treatment experience any events such as minor or major bleedings, stroke, sickness of the heart or blood vessels. In addition, information on why and when treating doctors decide to start or stop the treatment with rivaroxaban and acetylsalicylic acid is of interest to the researchers. The study plans to enroll about 300 male or female patients who are at least 18 years old and are already treated with the two drugs or at least with rivaroxaban.

Conditions

• Prevention of Atherothrombotic Events
• Coronary Artery Disease (CAD)
• Symptomatic Peripheral Artery Disease (Symptomatic PAD)

Interventions

Type	Name	Description
DRUG	Rivaroxaban (Xarelto,Bay 59-7939)	Rivaroxaban (2.5 mg \[BID\])
DRUG	Acetylsalicylic acid(ASA)	ASA (75mg \[QD\]; dose according to local label.

Timeline

• Start date: 2022-02-25
• Primary completion: 2024-03-28
• Completion: 2024-06-06
• First posted: 2020-03-06
• Last updated: 2024-06-28

Locations

1 site across 1 country: India