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

NCT03746275 | Completed

• 1 other identifier: 20280
• Study Type: observational
• Target: 5,798
• Locations: 18 countries
• Sites: 18

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.

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

Outcome Measures

Primary Outcomes (13)

• Descriptive analysis of patient history of CAD

  At baseline

• Descriptive analysis of patient history of PAD

  At baseline

• Descriptive analysis of prior antithrombotic treatment

  At baseline

• Descriptive analysis of concomitant antithrombotic treatment

  Up to 30.5 months

• Descriptive analysis of prior secondary prevention therapies

  At baseline

• Descriptive analysis of concomitant secondary prevention therapies

  Up to 30.5 months

• Reason for start of rivaroxaban

  Reasons include past ischemic events, co-morbidities and medical history.

  At baseline

• 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

• 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

• Planned duration of treatment with acetylsalicylic acid

  At baseline

• Actual duration of treatment with acetylsalicylic acid

  Up to 30.5 months

Secondary Outcomes (20)

• Occurrence of major adverse cardiac events

  Up to 30.5 months

• Occurrence of stroke

  Up to 30.5 months

• Occurrence of myocardial infarction

  Up to 30.5 months

• Occurrence of cardiovascular death

  Up to 30.5 months

• Occurrence of major adverse limb events

  Up to 30.5 months

Study Arms (1)

CAD/PAD-patients

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

Drug: Rivaroxaban (BAY59-7939, Xarelto); Drug: Acetylsalicylic acid

Interventions

Rivaroxaban (BAY59-7939, Xarelto) DRUG

2.5 mg twice daily

Also known as: Xarelto

CAD/PAD-patients

Acetylsalicylic acid DRUG

75 - 100 mg once daily according to local label

Also known as: Aspirin

CAD/PAD-patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults in routine medical practice, multi-national

You may qualify if:

• 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.

You may not qualify if:

• Patients who will be treated with chronic anticoagulation therapy other than rivaroxaban 2.5 mg given for CAD/PAD.
• Participation in an interventional trial.

Sponsors & Collaborators

• Bayer: lead
• Janssen, LP: collaborator

Study Sites (18)

Multiple facilities

Multiple Locations, Argentina

Location

Multiple facilities

Multiple Locations, Brazil

Location

Multiple facilities

Multiple Locations, Canada

Location

Multiple facilities

Multiple Locations, Denmark

Location

Multiple facilities

Multiple Locations, Germany

Location

Multiple facilities

Multiple Locations, Israel

Location

Multiple facilities

Multiple Locations, Lebanon

Location

Multiple facilities

Multiple Locations, Luxembourg

Location

Multiple facilities

Multiple Locations, Mexico

Location

Multiple facilities

Multiple Locations, Norway

Location

Multiple facilities

Multiple Locations, Russia

Location

Multiple facilities

Multiple Locations, Slovenia

Location

Multiple facilities

Multiple Locations, South Korea

Location

Multiple facilities

Multiple Locations, Sweden

Location

Multiple facilities

Multiple Locations, Switzerland

Location

Multiple facilities

Multiple Locations, Thailand

Location

Multiple facilities

Multiple Locations, United Arab Emirates

Location

Multiple facilities

Multiple Locations, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 32092505 DERIVED

Related Links

• Click here to find results for studies related to Bayer products

MeSH Terms

Conditions

Atherosclerosis; Coronary Artery Disease; Peripheral Arterial Disease; Cardiovascular Diseases; Thrombosis; Embolism; Thromboembolism

Interventions

Rivaroxaban; Aspirin

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Peripheral Vascular Diseases; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: November 19, 2018
• Study Start: November 13, 2018
• Primary Completion: June 8, 2021
• Study Completion: July 13, 2021
• Last Updated: May 2, 2022

Record last verified: 2022-04

Locations

LU (1); NO (1); LE (1); RU (1); AR (1); BR (1); SL (1); ME (1); CA (1); SE (1); DE (1); CH (1); TH (1); AE (1); KR (1); GB (1); IL (1); DK (1)