Study to Gain Insights in Treatment Patterns and Outcomes in Patients With Atherosclerosis Prescribed to Xarelto in Combination With Acetylsalicylic Acid

Atherosclerosis Clinical Trial

— XATOA  

Official title:

Xarelto + Acetylsalicylic Acid: Treatment Patterns and Outcomes in Patients With Atherosclerosis. A Non-interventional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03746275
• Other study ID #: 20280
• Status: Completed
• Start date: November 13, 2018
• Est. completion date: July 13, 2021

Study information

• Verified date: April 2022
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 5798
• Est. completion date: July 13, 2021
• Est. primary completion date: June 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Drug:
• Rivaroxaban (BAY59-7939, Xarelto)
2.5 mg twice daily
• Acetylsalicylic acid
75 - 100 mg once daily according to local label

Locations

Country	Name	City	State
Argentina	Multiple facilities	Multiple Locations
Brazil	Multiple facilities	Multiple Locations
Canada	Multiple facilities	Multiple Locations
Denmark	Multiple facilities	Multiple Locations
Germany	Multiple facilities	Multiple Locations
Israel	Multiple facilities	Multiple Locations
Korea, Republic of	Multiple facilities	Multiple Locations
Lebanon	Multiple facilities	Multiple Locations
Luxembourg	Multiple facilities	Multiple Locations
Mexico	Multiple facilities	Multiple Locations
Norway	Multiple facilities	Multiple Locations
Russian Federation	Multiple facilities	Multiple Locations
Slovenia	Multiple facilities	Multiple Locations
Sweden	Multiple facilities	Multiple Locations
Switzerland	Multiple facilities	Multiple Locations
Thailand	Multiple facilities	Multiple Locations
United Arab Emirates	Multiple facilities	Multiple Locations
United Kingdom	Multiple facilities	Multiple Locations

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen, LP

Countries where clinical trial is conducted

Argentina,  Brazil,  Canada,  Denmark,  Germany,  Israel,  Korea, Republic of,  Lebanon,  Luxembourg,  Mexico,  Norway,  Russian Federation,  Slovenia,  Sweden,  Switzerland,  Thailand,  United Arab Emirates,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Descriptive analysis of patient history of CAD		At baseline
Primary	Descriptive analysis of patient history of PAD		At baseline
Primary	Descriptive analysis of prior antithrombotic treatment		At baseline
Primary	Descriptive analysis of concomitant antithrombotic treatment		Up to 30.5 months
Primary	Descriptive analysis of prior secondary prevention therapies		At baseline
Primary	Descriptive analysis of concomitant secondary prevention therapies		Up to 30.5 months
Primary	Reason for start of rivaroxaban	Reasons include past ischemic events, co-morbidities and medical history.	At baseline
Primary	Decision point for start of rivaroxaban	Time point of start of medication in relation to disease progress and/ or occurrence of ischemic events.	At baseline
Primary	Reason for discontinuation of rivaroxaban		Up to 30.5 months
Primary	Planned duration of treatment with rivaroxaban		At baseline
Primary	Actual duration of treatment with rivaroxaban		Up to 30.5 months
Primary	Planned duration of treatment with acetylsalicylic acid		At baseline
Primary	Actual duration of treatment with acetylsalicylic acid		Up to 30.5 months
Secondary	Occurrence of major adverse cardiac events	Composite measure of stroke, myocardial infarction and cardiovascular death	Up to 30.5 months
Secondary	Occurrence of stroke		Up to 30.5 months
Secondary	Occurrence of myocardial infarction		Up to 30.5 months
Secondary	Occurrence of cardiovascular death		Up to 30.5 months
Secondary	Occurrence of major adverse limb events	Major adverse limb events comprise acute/severe limb ischemia including major amputation and chronic limb ischemia.	Up to 30.5 months
Secondary	Occurrence of acute/severe limb ischemia		Up to 30.5 months
Secondary	Occurrence of chronic limb ischemia		Up to 30.5 months
Secondary	Occurrence of major amputation		Up to 30.5 months
Secondary	Anti-thrombotic treatment pattern after major adverse limb event	Treatment pattern comprises drug name, dose and duration of treatment.	Up to 30.5 months
Secondary	Occurrence of thromboembolic events	Thromboembolic events include systemic embolism and venous thromboembolism.	Up to 30.5 months
Secondary	Occurrence of haemorrhagic events	A haemorrhagic event is any event related to bleeding.	Up to 30.5 months
Secondary	Occurrence of death from cardiovascular events		Up to 30.5 months
Secondary	Occurrence of death from any cause		Up to 30.5 months
Secondary	Occurrence of cardiac revascularization procedures	Includes percutaneous coronary intervention and coronary artery bypass grafting.	Up to 30.5 months
Secondary	Occurrence of peripheral revascularization procedures		Up to 30.5 months
Secondary	Occurrence of carotid revascularization procedures		Up to 30.5 months
Secondary	Occurrence of hospitalizations	Hospitalizations due to stroke, cardiovascular reasons, major adverse limb events or bleeding complications.	Up to 30.5 months
Secondary	Duration of hospitalization	Time in days of hospitalization due to stroke, cardiovascular reasons, major adverse limb events or bleeding complications.	Up to 30.5 months
Secondary	Total walking distance of PAD patients		Up to 30.5 months
Secondary	Pain-free walking distance of PAD patients		Up to 30.5 months

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