Trial Condition(s):

Prevention of atherothrombotic events, Coronary Artery Disease (CAD), Symptomatic peripheral artery disease (Symptomatic PAD)

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)

Bayer Identifier:

21269

ClinicalTrials.gov Identifier:

NCT04298567

EudraCT Number:

Not Available

Recruiting

Trial Purpose

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.

Inclusion Criteria
- 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 Criteria
- 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.

Trial Summary

Enrollment Goal
300
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)+ASA
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many locations

Many locations, India

Status
Recruiting
 

Trial Design