Clinical trial 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)
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prevention of Atherothrombotic Events
Coronary Artery Disease (CAD)
Symptomatic Peripheral Artery Disease (Symptomatic PAD)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-03-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female and male patients with a diagnosis of CAD or symptomatic PAD will be enrolled within 4 weeks after the decision for treatment with rivaroxaban plus ASA has been made by the investigator.

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with haemorrhagic events and complications
timeFrame: Up to 13 months
Secondary outcomes:
measure: Number of participants with major adverse cardiovascular events (MACE)
timeFrame: Up to 13 months
measure: Number of participants with major adverse limb events (MALE)
timeFrame: Up to 13 months
measure: Number of participants with thromboembolic events
timeFrame: Up to 13 months
measure: Number of participants with cardiovascular mortality
timeFrame: Up to 13 months
measure: Number of participants with all-cause mortality
timeFrame: Up to 13 months
measure: Number of participants with cardiac revascularization procedures
timeFrame: Up to 13 months
measure: Number of participants with peripheral revascularization procedures
timeFrame: Up to 13 months
measure: Number of participants with carotid revascularization procedures
timeFrame: Up to 13 months
measure: Duration of hospitalizations
timeFrame: Up to 13 months
measure: Total and pain free walking distance per individual for PAD patients
timeFrame: Change from baseline up to 13 months
measure: Number of participants with history and diagnosis of CAD or PAD
timeFrame: Up to 13 months
measure: Number of participants with individual risk
timeFrame: Up to 13 months
measure: Number of participants with revascularization procedures and prior interventions (PCI, CABG), peripheral revascularization procedures
timeFrame: Up to 13 months
measure: Type of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PAD
timeFrame: Up to 13 months
measure: Dose of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PAD
timeFrame: Up to 13 months
measure: Duration of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PAD
timeFrame: Up to 13 months
measure: Reasons and decision points for introducing rivaroxaban 2.5 mg [BID]
timeFrame: Up to 13 months
measure: Reasons for discontinuation of rivaroxaban 2.5 mg [BID].
timeFrame: Up to 13 months
measure: Planned and actual duration of treatment with rivaroxaban 2.5 mg [BID].
timeFrame: Up to 13 months
measure: Planned and actual duration of treatment with ASA 75 mg [OD]
timeFrame: Up to 13 months
Other outcomes:
Locations:
city: Multiple Locations
country: India
facility: Many locations
Study officials:
References: