Trial Condition(s):
Atherosclerosis
Study to gain insights in treatment patterns and outcomes in patients with atherosclerosis prescribed to Xarelto in combination with acetylsalicylic acid (XATOA)
Bayer Identifier:
20280
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
Inclusion Criteria
- 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.Exclusion Criteria
- Patients who will be treated with chronic anticoagulation therapy other than rivaroxaban 2.5 mg given for CAD/PAD.
- Participation in an interventional trial.Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Multiple facilities Many locations, Germany | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Multiple facilities Many locations, United Kingdom | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Multiple facilities Many locations, Canada | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Multiple facilities Many locations, Mexico | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Multiple facilities Many locations, Sweden | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Multiple facilities Many locations, Denmark | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Multiple facilities Many locations, Norway | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Multiple facilities Many locations, Israel | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Multiple facilities Many locations, Argentina | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Multiple facilities Many locations, Brazil | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Multiple facilities Many locations, Russia | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Multiple facilities Many locations, South Korea | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Multiple facilities Many locations, Thailand | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Multiple facilities Many locations, Luxembourg | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Multiple facilities Many locations, Switzerland | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Multiple facilities Many locations, Lebanon | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Multiple facilities Many locations, United Arab Emirates | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Multiple facilities Many locations, Slovenia | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Xarelto + Acetylsalicylic acid: Treatment patterns and Outcomes in patients with Atherosclerosis. A non-interventional study
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Descriptive analysis of patient history of CADTimeframe: At baseline
- Descriptive analysis of patient history of PADTimeframe: At baseline
- Descriptive analysis of prior antithrombotic treatmentTimeframe: At baseline
- Descriptive analysis of concomitant antithrombotic treatmentTimeframe: Up to 30.5 months
- Descriptive analysis of prior secondary prevention therapiesTimeframe: At baseline
- Descriptive analysis of concomitant secondary prevention therapiesTimeframe: Up to 30.5 months
- Reason for start of rivaroxabanReasons include past ischemic events, co-morbidities and medical history.Timeframe: At baseline
- Decision point for start of rivaroxabanTime point of start of medication in relation to disease progress and/ or occurrence of ischemic events.Timeframe: At baseline
- Reason for discontinuation of rivaroxabanTimeframe: Up to 30.5 months
- Planned duration of treatment with rivaroxabanTimeframe: At baseline
- Actual duration of treatment with rivaroxabanTimeframe: Up to 30.5 months
- Planned duration of treatment with acetylsalicylic acidTimeframe: At baseline
- Actual duration of treatment with acetylsalicylic acidTimeframe: Up to 30.5 months
Secondary Outcome
- Occurrence of major adverse cardiac eventsComposite measure of stroke, myocardial infarction and cardiovascular deathTimeframe: Up to 30.5 months
- Occurrence of strokeTimeframe: Up to 30.5 months
- Occurrence of myocardial infarctionTimeframe: Up to 30.5 months
- Occurrence of cardiovascular deathTimeframe: Up to 30.5 months
- Occurrence of major adverse limb eventsMajor adverse limb events comprise acute/severe limb ischemia including major amputation and chronic limb ischemia.Timeframe: Up to 30.5 months
- Occurrence of acute/severe limb ischemiaTimeframe: Up to 30.5 months
- Occurrence of chronic limb ischemiaTimeframe: Up to 30.5 months
- Occurrence of major amputationTimeframe: Up to 30.5 months
- Anti-thrombotic treatment pattern after major adverse limb eventTreatment pattern comprises drug name, dose and duration of treatment.Timeframe: Up to 30.5 months
- Occurrence of thromboembolic eventsThromboembolic events include systemic embolism and venous thromboembolism.Timeframe: Up to 30.5 months
- Occurrence of haemorrhagic eventsA haemorrhagic event is any event related to bleeding.Timeframe: Up to 30.5 months
- Occurrence of death from cardiovascular eventsTimeframe: Up to 30.5 months
- Occurrence of death from any causeTimeframe: Up to 30.5 months
- Occurrence of cardiac revascularization proceduresIncludes percutaneous coronary intervention and coronary artery bypass grafting.Timeframe: Up to 30.5 months
- Occurrence of peripheral revascularization proceduresTimeframe: Up to 30.5 months
- Occurrence of carotid revascularization proceduresTimeframe: Up to 30.5 months
- Occurrence of hospitalizationsHospitalizations due to stroke, cardiovascular reasons, major adverse limb events or bleeding complications.Timeframe: Up to 30.5 months
- Duration of hospitalizationTime in days of hospitalization due to stroke, cardiovascular reasons, major adverse limb events or bleeding complications.Timeframe: Up to 30.5 months
- Total walking distance of PAD patientsTimeframe: Up to 30.5 months
- Pain-free walking distance of PAD patientsTimeframe: Up to 30.5 months
Additional Information
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