A Study to Collect Data on the Treatment Pattern of Xarelto + Acetylsalicylic Acid in the Routine Clinical Practice in Patients Who Are Suffering From a Condition That Narrows the Blood Vessels Supplying the Heart and / or a Condition That Most Commonly Narrows the Blood Vessel in the Legs (XATOC)

Xarelto + Acetylsalicylic Acid: Treatment Patterns and Outcomes Across the Disease Continuum in Patients With CAD and/or PAD

The study will focus on effectiveness and safety of rivaroxaban (Xarelto) when given together with acetylsalicylic acid (combination therapy) to patients suffering from coronary artery disease (a condition that affects the blood vessels supplying the heart) and / or peripheral artery disease (a condition that affects the blood vessels of the lower limbs) in the routine clinical practice. The study will help to collect data for prevention cardiovascular death, myocardial infarction (MI), stroke and major adverse limb events in adult patients. The study will focus on information on when and why physicians are starting to treat patients with combination therapy, treatment duration, reasons to discontinue treatment and previous therapies. The study will also investigate treatment outcomes for patients being treated with a combination therapy by their physicians.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Peripheral Artery Disease
• Intervention / Treatment: Drug: Rivaroxaban (BAY59-7939, Xarelto); Drug: Acetylsalicylic acid

• Study Type: Observational
• Enrollment (Actual): 3189

Contacts and Locations

• Study Contact: Name: Bayer Clinical Trials Contact; Phone Number: (+)1-888-84 22937; Email: clinical-trials-contact@bayer.com

Study Locations

• Belgium
  • Multiple Locations, Belgium
    • Many Locations
• China
  • Multiple Locations, China
    • Many Locations
• Colombia
  • Multiple Locations, Colombia
    • Many Locations
• Italy
  • Multiple Locations, Italy
    • Many Locations
• Korea, Republic of
  • Multiple Locations, Korea, Republic of
    • Many Locations
• Russian Federation
  • Multiple Locations, Russian Federation
    • Many Locations
• Slovenia
  • Multiple Locations, Slovenia
    • Many Locations
• Spain
  • Multiple Locations, Spain
    • Many Locations
• Switzerland
  • Multiple Locations, Switzerland
    • Many Locations
• Taiwan
  • Multiple Locations, Taiwan
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

International population of adult CAD/PAD patients

Description

Inclusion Criteria:

• Adult (≥18 years) patient (except Taiwan ≥ 20 years old).
• Diagnosis of CAD or symptomatic PAD.
• Treatment according to local marketing authorization, rivaroxaban 2.5 mg [BID] plus Acetylsalicylic acid (ASA) 75-100 mg [OD] started up to 4 weeks before or after the ICF is signed.
• Only in those countries with a marketing authorization of rivaroxaban in the Acute Coronary Syndrome (ACS) indication, patients already on rivaroxaban treatment for ACS for more than 4 weeks, who are subsequently fulfilling criteria for CAD, are also allowed to be enrolled.

Exclusion Criteria:

• Contra-indications according to the local marketing authorization.
• Patients who will be treated with chronic anticoagulation therapy other than rivaroxaban 2.5 mg given for CAD/PAD.
• Participation in an interventional trial.
• Enrolment in the XATOA study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CAD/PAD-patients; Adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) who are treated with a combination of rivaroxaban and acetylsalicylic acid.	Drug: Rivaroxaban (BAY59-7939, Xarelto); 2.5 mg twice daily; Other Names: Xarelto; Drug: Acetylsalicylic acid; 75 - 100 mg once daily at the discretion of the investigator; Other Names: Aspirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Descriptive analysis of prior antithrombotic treatment		At baseline
Descriptive analysis of prior secondary prevention therapies		At baseline
Planned duration of treatment with rivaroxaban		At baseline
Health status by questionnaire EQ-5D-5L	Self-reported health-related quality of life is measured with EQ-5D at the initial visit and at each follow-up visit. Items are scored from 1 (no problems) to 5 (extreme problems) leading to a total score from 0 (worst imaginable health) to 100 (best imaginable health).	Up to 34 months
Descriptive analysis of clinical characteristics of CAD participants		At baseline
Descriptive analysis of clinical characteristics of PAD participants		At baseline
Descriptive analysis of concomitant antithrombotic treatment		Upto 34 months
Descriptive analysis of concomitant secondary prevention therapies		Up to 34 months
Reason to start rivaroxaban	Reasons include past ischemic events, co-morbidities and medical history.	At baseline
Decision point to start rivaroxaban	Time point of start of medication in relation to disease progress and/ or occurrence of ischemic events	At baseline
Reasons for discontinuation of rivaroxaban		Up to 34 months
Actual duration of treatment with rivaroxaban		Up to 34 months
Planned duration of treatment with Acetylsalicylic acid (ASA)		At baseline
Actual duration of treatment with ASA		Up to 34 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with major adverse cardiovascular events (MACE)	Composite endpoint comprising of myocardial infarction, stroke, and cardiovascular death (and single components).	Up to 34 months
Number of participants with major adverse limb events (MALE)	Major adverse limb events comprise acute limb ischemia and vascular amputation, and antithrombotic treatment [pattern] after MALE.	Up to 34 months
Number of participants with antithrombotic treatment after MALE		Up to 34 months
Number of participants with MACE or MALE	Composite endpoint comprising myocardial infarction, ischemic stroke, cardiovascular death, acute limb ischemia, major amputation of vascular etiology.	Up to 34 months
Number of participants with thromboembolic events	Thromboembolic events include e.g. systemic embolism and venous thromboembolism.	Up to 34 months
Number of participants with haemorrhagic events and complications	The major bleeding complications will be collected according to the International Society on Thrombosis and Haemostasis (ISTH) criteria, modified ISTH criteria, and Thrombolysis in Myocardial Infarction (TIMI) criteria.	Up to 34 months
Number of deaths due to cardiovascular events		Up to 34 months
Number of deaths due to any cause		Up to 34 months
Number of participants with cardiac revascularization procedures	Cardiac revascularization procedure includes Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG)	Up to 34 months
Number of participants with peripheral revascularization procedures		Up to 34 months
Number of participants with lower limb revascularization procedures.		Up to 34 months
Number of participants with carotid revascularization procedures		Up to 34 months
Number of hospitalizations	Number of hospitalizations due to stroke, cardiovascular reasons, MALE, or bleeding complications.	Up to 34 months
Duration of hospitalizations	Hospitalizations due to stroke, cardiovascular reasons, MALE, or bleeding complications.	Up to 34 months
Total walking distance per individual for PAD participants		Up to 34 months
Pain free walking distance per individual for PAD participants		Up to 34 months
Patient-reported walking impairment by Walking Impairment Questionnaire (WIQ) for PAD participants	The WIQ is a validated questionnaire that measures patient-reported walking limitations in distance, stair climbing and speed. Final score ranges from 0 (unable to walk) to 4 (no difficulty to walk).	Up to 34 months

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2020
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): September 29, 2023

Study Registration Dates

• First Submitted: May 22, 2020
• First Submitted That Met QC Criteria: May 22, 2020
• First Posted (Actual): May 26, 2020

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Thrombosis
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Coronary Disease; Peripheral Vascular Diseases; Coronary Artery Disease; Peripheral Arterial Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Aspirin; Rivaroxaban
• Other Study ID Numbers: 21283

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No