Study to Gain Insights in Treatment Patterns and Outcomes in Patients With Atherosclerosis Prescribed to Xarelto in Combination With Acetylsalicylic Acid
- Conditions
- Atherosclerosis
- Interventions
- Registration Number
- NCT03746275
- Lead Sponsor
- Bayer
- Brief Summary
In this study researchers want to gain more information on treatment patterns of patients treated with Xarelto in combination with acetylsalicylic acid (ASA). Both drugs reduce the risk of blood clots via different pathways. The study will enroll adult patients suffering from coronary artery disease (narrowing or blockage of vessels that supply the heart with blood) or peripheral artery disease (narrowing or blockage of vessels that supply the legs or head with blood). The study will focus on information on when and why physicians are starting to treat patients with Xarelto in addition to ASA, treatment duration, reasons to discontinue treatment and previous therapies. The study will also look into treatment outcomes for patients being treated with a combination of Xarelto and ASA by their physicians.
- Detailed Description
The study aims to collect real-world data on treatment patterns and decision points for treatment in patients with coronary artery disease (CAD) and/ or peripheral artery disease (PAD) treated with rivaroxaban 2.5 mg \[twice daily\] for the prevention of major cardiovascular events in adult patients with CAD at high risk of ischemic events and/ or documented PAD and to describe outcomes of an antithrombotic regime based on dual pathway inhibition (vascular dose of rivaroxaban 2.5 mg \[twice daily\] plus low-dose ASA \[once daily\]) across the broad range of patient risk profiles encountered in routine clinical practice.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5798
- Adults with diagnosis Coronary Artery Disease (CAD) or Peripheral Artery Disease (PAD).
- Treatment according to local marketing authorization, rivaroxaban 2.5 mg twice daily started within 4 weeks prior to enrolment. Only in those countries with a marketing authorization of rivaroxaban in the acute coronary syndrome (ACS) indication, 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 will be treated with chronic anticoagulation therapy other than rivaroxaban 2.5 mg given for CAD/PAD.
- Participation in an interventional trial.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CAD/PAD-patients Rivaroxaban (BAY59-7939, Xarelto) Adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) from Europe, Asia, Latin America and Canada, who are treated with a combination of rivaroxaban and acetylsalicylic acid to prevent atherothrombotic events CAD/PAD-patients Acetylsalicylic acid Adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) from Europe, Asia, Latin America and Canada, who are treated with a combination of rivaroxaban and acetylsalicylic acid to prevent atherothrombotic events
- Primary Outcome Measures
Name Time Method Descriptive analysis of patient history of CAD At baseline Descriptive analysis of prior antithrombotic treatment At baseline Descriptive analysis of concomitant secondary prevention therapies Up to 30.5 months Decision point for start of rivaroxaban At baseline Time point of start of medication in relation to disease progress and/ or occurrence of ischemic events.
Planned duration of treatment with acetylsalicylic acid At baseline Descriptive analysis of patient history of PAD At baseline Descriptive analysis of concomitant antithrombotic treatment Up to 30.5 months Descriptive analysis of prior secondary prevention therapies At baseline Reason for start of rivaroxaban At baseline Reasons include past ischemic events, co-morbidities and medical history.
Reason for discontinuation of rivaroxaban Up to 30.5 months Planned duration of treatment with rivaroxaban At baseline Actual duration of treatment with rivaroxaban Up to 30.5 months Actual duration of treatment with acetylsalicylic acid Up to 30.5 months
- Secondary Outcome Measures
Name Time Method Occurrence of major adverse cardiac events Up to 30.5 months Composite measure of stroke, myocardial infarction and cardiovascular death
Occurrence of myocardial infarction Up to 30.5 months Occurrence of cardiovascular death Up to 30.5 months Occurrence of chronic limb ischemia Up to 30.5 months Occurrence of death from cardiovascular events Up to 30.5 months Occurrence of death from any cause Up to 30.5 months Occurrence of cardiac revascularization procedures Up to 30.5 months Includes percutaneous coronary intervention and coronary artery bypass grafting.
Occurrence of peripheral revascularization procedures Up to 30.5 months Occurrence of carotid revascularization procedures Up to 30.5 months Occurrence of acute/severe limb ischemia Up to 30.5 months Occurrence of major adverse limb events Up to 30.5 months Major adverse limb events comprise acute/severe limb ischemia including major amputation and chronic limb ischemia.
Anti-thrombotic treatment pattern after major adverse limb event Up to 30.5 months Treatment pattern comprises drug name, dose and duration of treatment.
Occurrence of thromboembolic events Up to 30.5 months Thromboembolic events include systemic embolism and venous thromboembolism.
Occurrence of haemorrhagic events Up to 30.5 months A haemorrhagic event is any event related to bleeding.
Occurrence of hospitalizations Up to 30.5 months Hospitalizations due to stroke, cardiovascular reasons, major adverse limb events or bleeding complications.
Duration of hospitalization Up to 30.5 months Time in days of hospitalization due to stroke, cardiovascular reasons, major adverse limb events or bleeding complications.
Total walking distance of PAD patients Up to 30.5 months Pain-free walking distance of PAD patients Up to 30.5 months Occurrence of stroke Up to 30.5 months Occurrence of major amputation Up to 30.5 months
Trial Locations
- Locations (1)
Multiple facilities
🇬🇧Multiple Locations, United Kingdom