Clinical trial NCT03746275: Study to Gain Insights in Treatment Patterns and Outcomes in Patients With Atherosclerosis Prescribed to Xarelto in Combination With Acetylsalicylic Acid
Official title: Xarelto + Acetylsalicylic Acid: Treatment Patterns and Outcomes in Patients With Atherosclerosis. A Non-interventional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Keywords: Coronary artery disease (CAD)
Peripheral artery disease (PAD)
Major adverse limb events (MALE)
Major adverse cardiac events (MACE)
Atherosclerosis
Atherothrombosis
Thrombosis
Embolism
Thromboembolism
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen, LP
First posted: 2018-11-19
Enrollment: 5798
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults in routine medical practice, multi-national

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Descriptive analysis of patient history of CAD
timeFrame: At baseline
measure: Descriptive analysis of patient history of PAD
timeFrame: At baseline
measure: Descriptive analysis of prior antithrombotic treatment
timeFrame: At baseline
measure: Descriptive analysis of concomitant antithrombotic treatment
timeFrame: Up to 30.5 months
measure: Descriptive analysis of prior secondary prevention therapies
timeFrame: At baseline
measure: Descriptive analysis of concomitant secondary prevention therapies
timeFrame: Up to 30.5 months
measure: Reason for start of rivaroxaban
timeFrame: At baseline
measure: Decision point for start of rivaroxaban
timeFrame: At baseline
measure: Reason for discontinuation of rivaroxaban
timeFrame: Up to 30.5 months
measure: Planned duration of treatment with rivaroxaban
timeFrame: At baseline
measure: Actual duration of treatment with rivaroxaban
timeFrame: Up to 30.5 months
measure: Planned duration of treatment with acetylsalicylic acid
timeFrame: At baseline
measure: Actual duration of treatment with acetylsalicylic acid
timeFrame: Up to 30.5 months
Secondary outcomes:
measure: Occurrence of major adverse cardiac events
timeFrame: Up to 30.5 months
measure: Occurrence of stroke
timeFrame: Up to 30.5 months
measure: Occurrence of myocardial infarction
timeFrame: Up to 30.5 months
measure: Occurrence of cardiovascular death
timeFrame: Up to 30.5 months
measure: Occurrence of major adverse limb events
timeFrame: Up to 30.5 months
measure: Occurrence of acute/severe limb ischemia
timeFrame: Up to 30.5 months
measure: Occurrence of chronic limb ischemia
timeFrame: Up to 30.5 months
measure: Occurrence of major amputation
timeFrame: Up to 30.5 months
measure: Anti-thrombotic treatment pattern after major adverse limb event
timeFrame: Up to 30.5 months
measure: Occurrence of thromboembolic events
timeFrame: Up to 30.5 months
measure: Occurrence of haemorrhagic events
timeFrame: Up to 30.5 months
measure: Occurrence of death from cardiovascular events
timeFrame: Up to 30.5 months
measure: Occurrence of death from any cause
timeFrame: Up to 30.5 months
measure: Occurrence of cardiac revascularization procedures
timeFrame: Up to 30.5 months
measure: Occurrence of peripheral revascularization procedures
timeFrame: Up to 30.5 months
measure: Occurrence of carotid revascularization procedures
timeFrame: Up to 30.5 months
measure: Occurrence of hospitalizations
timeFrame: Up to 30.5 months
measure: Duration of hospitalization
timeFrame: Up to 30.5 months
measure: Total walking distance of PAD patients
timeFrame: Up to 30.5 months
measure: Pain-free walking distance of PAD patients
timeFrame: Up to 30.5 months
Other outcomes:
Locations:
city: Multiple Locations
country: Argentina
facility: Multiple facilities
city: Multiple Locations
country: Brazil
facility: Multiple facilities
city: Multiple Locations
country: Canada
facility: Multiple facilities
city: Multiple Locations
country: Denmark
facility: Multiple facilities
city: Multiple Locations
country: Germany
facility: Multiple facilities
city: Multiple Locations
country: Israel
facility: Multiple facilities
city: Multiple Locations
country: Korea, Republic of
facility: Multiple facilities
city: Multiple Locations
country: Lebanon
facility: Multiple facilities
city: Multiple Locations
country: Luxembourg
facility: Multiple facilities
city: Multiple Locations
country: Mexico
facility: Multiple facilities
city: Multiple Locations
country: Norway
facility: Multiple facilities
city: Multiple Locations
country: Russian Federation
facility: Multiple facilities
city: Multiple Locations
country: Slovenia
facility: Multiple facilities
city: Multiple Locations
country: Sweden
facility: Multiple facilities
city: Multiple Locations
country: Switzerland
facility: Multiple facilities
city: Multiple Locations
country: Thailand
facility: Multiple facilities
city: Multiple Locations
country: United Arab Emirates
facility: Multiple facilities
city: Multiple Locations
country: United Kingdom
facility: Multiple facilities
Study officials:
References:
citation: Fox KAA, Anand SS, Aboyans V, Cowie MR, Debus ES, Zeymer U, Monje D, Vogtlander K, Lawatscheck R, Gay A. Xarelto plus Acetylsalicylic acid: Treatment patterns and Outcomes in patients with Atherosclerosis (XATOA): Rationale and design of a prospective registry study to assess rivaroxaban 2.5 mg twice daily plus aspirin for prevention of atherothrombotic events in coronary artery disease, peripheral artery disease, or both. Am Heart J. 2020 Apr;222:166-173. doi: 10.1016/j.ahj.2020.01.015. Epub 2020 Jan 28.