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)
- Conditions
- Symptomatic Peripheral Artery Disease (Symptomatic PAD)Prevention of Atherothrombotic EventsCoronary Artery Disease (CAD)
- Interventions
- Drug: Acetylsalicylic acid(ASA)
- Registration Number
- NCT04298567
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- 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).
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Treatment Rivaroxaban (Xarelto,Bay 59-7939) 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 2.5mg \[BID\] plus ASA 75mg \[OD\] has been made by the investigator. Treatment Acetylsalicylic acid(ASA) 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 2.5mg \[BID\] plus ASA 75mg \[OD\] has been made by the investigator.
- Primary Outcome Measures
Name Time Method Number of participants with haemorrhagic events and complications Up to 13 months 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.
- Secondary Outcome Measures
Name Time Method Planned and actual duration of treatment with rivaroxaban 2.5 mg [BID]. Up to 13 months Number of participants with major adverse cardiovascular events (MACE) Up to 13 months MACE: composite of MI, stroke, and cardiovascular death (and single components)
Number of participants with carotid revascularization procedures Up to 13 months Duration of hospitalizations Up to 13 months Hospitalizations includes stroke, cardiovascular reasons, MALE, or bleeding complications.
Number of participants with history and diagnosis of CAD or PAD Up to 13 months History and diagnosis of CAD, incl. history of myocardial infarction and vessel status.
History and diagnosis of PAD, incl. ankle-brachial index (ABI).Dose of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PAD Up to 13 months Reasons and decision points for introducing rivaroxaban 2.5 mg [BID] Up to 13 months BID: twice per day dosing
Number of participants with major adverse limb events (MALE) Up to 13 months MALE: Major adverse limb events, incl. major amputation (and single components), and antithrombotic treatment patterns after MALE
Number of participants with all-cause mortality Up to 13 months Number of participants with peripheral revascularization procedures Up to 13 months Type of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PAD Up to 13 months Reasons for discontinuation of rivaroxaban 2.5 mg [BID]. Up to 13 months Number of participants with revascularization procedures and prior interventions (PCI, CABG), peripheral revascularization procedures Up to 13 months Planned and actual duration of treatment with ASA 75 mg [OD] Up to 13 months QD:once per day dosing
Number of participants with thromboembolic events Up to 13 months Thromboembolic events includes systemic embolism, venous thromboembolism
Number of participants with cardiovascular mortality Up to 13 months Number of participants with cardiac revascularization procedures Up to 13 months Cardiac revascularization procedure includes Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG)
Total and pain free walking distance per individual for PAD patients Change from baseline up to 13 months Number of participants with individual risk Up to 13 months 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.
Duration of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PAD Up to 13 months
Trial Locations
- Locations (1)
Many locations
🇮🇳Multiple Locations, India