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.
Study Type
OBSERVATIONAL
Enrollment
300
Rivaroxaban (2.5 mg \[BID\])
ASA (75mg \[QD\]; dose according to local label.
Many locations
Multiple Locations, India
Number of participants with haemorrhagic events and complications
Consisting of minor and major bleeding events. The major bleeding complications are collected according to the International Society on Thrombosis and Haemostasis (ISTH) criteria as a composite of fatal bleeding, symptomatic bleeding into a critical organ (such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome), bleeding into surgical site requiring reoperation, bleeding leading to hospitalization.
Time frame: Up to 13 months
Number of participants with major adverse cardiovascular events (MACE)
MACE: composite of MI, stroke, and cardiovascular death (and single components)
Time frame: Up to 13 months
Number of participants with major adverse limb events (MALE)
MALE: Major adverse limb events, incl. major amputation (and single components), and antithrombotic treatment patterns after MALE
Time frame: Up to 13 months
Number of participants with thromboembolic events
Thromboembolic events includes systemic embolism, venous thromboembolism
Time frame: Up to 13 months
Number of participants with cardiovascular mortality
Time frame: Up to 13 months
Number of participants with all-cause mortality
Time frame: Up to 13 months
Number of participants with cardiac revascularization procedures
Cardiac revascularization procedure includes Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG)
Time frame: Up to 13 months
Number of participants with peripheral revascularization procedures
Time frame: Up to 13 months
Number of participants with carotid revascularization procedures
Time frame: Up to 13 months
Duration of hospitalizations
Hospitalizations includes stroke, cardiovascular reasons, MALE, or bleeding complications.
Time frame: Up to 13 months
Total and pain free walking distance per individual for PAD patients
Time frame: Change from baseline up to 13 months
Number of participants with history and diagnosis of CAD or PAD
History and diagnosis of CAD, incl. history of myocardial infarction and vessel status. History and diagnosis of PAD, incl. ankle-brachial index (ABI).
Time frame: Up to 13 months
Number of participants with individual risk
Individual Risk classification: Co-morbidities (e.g. worsening symptoms, diabetes mellitus, chronic heart failure (CHF) renal impairment (eGFR \<60 ml/min), Cerebrovascular disease(, ≥ 2 peripheral vascular beds affected, intermittent claudication, ABI \<0.9, smoking, hypertension, hyperlipidaemia, carotid stenosis), and routinely collected key laboratory data.
Time frame: Up to 13 months
Number of participants with revascularization procedures and prior interventions (PCI, CABG), peripheral revascularization procedures
Time frame: Up to 13 months
Type of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PAD
Time frame: Up to 13 months
Dose of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PAD
Time frame: Up to 13 months
Duration of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PAD
Time frame: Up to 13 months
Reasons and decision points for introducing rivaroxaban 2.5 mg [BID]
BID: twice per day dosing
Time frame: Up to 13 months
Reasons for discontinuation of rivaroxaban 2.5 mg [BID].
Time frame: Up to 13 months
Planned and actual duration of treatment with rivaroxaban 2.5 mg [BID].
Time frame: Up to 13 months
Planned and actual duration of treatment with ASA 75 mg [OD]
QD:once per day dosing
Time frame: Up to 13 months
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