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)

• ClinicalTrials.gov Identifier: NCT04401761
• Recruitment Status: Recruiting
• First Posted: May 26, 2020
• Last Update Posted: March 20, 2023
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Coronary Artery Disease; Peripheral Artery Disease	Drug: Rivaroxaban (BAY59-7939, Xarelto); Drug: Acetylsalicylic acid

Study Design

• Study Type: Observational
• Estimated Enrollment: 3189 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Xarelto + Acetylsalicylic Acid: Treatment Patterns and Outcomes Across the Disease Continuum in Patients With CAD and/or PAD
• Actual Study Start Date: May 28, 2020
• Estimated Primary Completion Date: June 30, 2023
• Estimated Study Completion Date: September 30, 2023

Groups and Cohorts

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 Name: Xarelto; Drug: Acetylsalicylic acid; 75 - 100 mg once daily at the discretion of the investigator; Other Name: Aspirin

Outcome Measures

Primary Outcome Measures :

1. Health status by questionnaire EQ-5D-5L [ Time Frame: Up to 34 months ]
   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).
2. Descriptive analysis of clinical characteristics of CAD participants [ Time Frame: At baseline ]
3. Descriptive analysis of clinical characteristics of PAD participants [ Time Frame: At baseline ]
4. Descriptive analysis of prior antithrombotic treatment [ Time Frame: At baseline ]
5. Descriptive analysis of concomitant antithrombotic treatment [ Time Frame: Upto 34 months ]
6. Descriptive analysis of prior secondary prevention therapies [ Time Frame: At baseline ]
7. Descriptive analysis of concomitant secondary prevention therapies [ Time Frame: Up to 34 months ]
8. Reason to start rivaroxaban [ Time Frame: At baseline ]
   Reasons include past ischemic events, co-morbidities and medical history.
9. Decision point to start rivaroxaban [ Time Frame: At baseline ]
   Time point of start of medication in relation to disease progress and/ or occurrence of ischemic events
10. Reasons for discontinuation of rivaroxaban [ Time Frame: Up to 34 months ]
11. Planned duration of treatment with rivaroxaban [ Time Frame: At baseline ]
12. Actual duration of treatment with rivaroxaban [ Time Frame: Up to 34 months ]
13. Planned duration of treatment with Acetylsalicylic acid (ASA) [ Time Frame: At baseline ]
14. Actual duration of treatment with ASA [ Time Frame: Up to 34 months ]

Secondary Outcome Measures :

1. Number of participants with major adverse cardiovascular events (MACE) [ Time Frame: Up to 34 months ]
   Composite endpoint comprising of myocardial infarction, stroke, and cardiovascular death (and single components).
2. Number of participants with major adverse limb events (MALE) [ Time Frame: Up to 34 months ]
   Major adverse limb events comprise acute limb ischemia and vascular amputation, and antithrombotic treatment [pattern] after MALE.
3. Number of participants with antithrombotic treatment after MALE [ Time Frame: Up to 34 months ]
4. Number of participants with MACE or MALE [ Time Frame: Up to 34 months ]
   Composite endpoint comprising myocardial infarction, ischemic stroke, cardiovascular death, acute limb ischemia, major amputation of vascular etiology.
5. Number of participants with thromboembolic events [ Time Frame: Up to 34 months ]
   Thromboembolic events include e.g. systemic embolism and venous thromboembolism.
6. Number of participants with haemorrhagic events and complications [ Time Frame: Up to 34 months ]
   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.
7. Number of deaths due to cardiovascular events [ Time Frame: Up to 34 months ]
8. Number of deaths due to any cause [ Time Frame: Up to 34 months ]
9. Number of participants with cardiac revascularization procedures [ Time Frame: Up to 34 months ]
   Cardiac revascularization procedure includes Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG)
10. Number of participants with peripheral revascularization procedures [ Time Frame: Up to 34 months ]
11. Number of participants with lower limb revascularization procedures. [ Time Frame: Up to 34 months ]
12. Number of participants with carotid revascularization procedures [ Time Frame: Up to 34 months ]
13. Number of hospitalizations [ Time Frame: Up to 34 months ]
    Number of hospitalizations due to stroke, cardiovascular reasons, MALE, or bleeding complications.
14. Duration of hospitalizations [ Time Frame: Up to 34 months ]
    Hospitalizations due to stroke, cardiovascular reasons, MALE, or bleeding complications.
15. Total walking distance per individual for PAD participants [ Time Frame: Up to 34 months ]
16. Pain free walking distance per individual for PAD participants [ Time Frame: Up to 34 months ]
17. Patient-reported walking impairment by Walking Impairment Questionnaire (WIQ) for PAD participants [ Time Frame: Up to 34 months ]
    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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Sampling Method: Non-Probability Sample

Study Population

International population of adult CAD/PAD patients

Criteria

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.

Contacts and Locations

Contacts

Contact: Bayer Clinical Trials Contact; (+)1-888-84 22937; clinical-trials-contact@bayer.com

Locations

Belgium

Many Locations; Recruiting

Multiple Locations, Belgium

Brazil

Many Locations; Not yet recruiting

Multiple Locations, Brazil

Canada

Many Locations; Not yet recruiting

Multiple Locations, Canada

China

Many Locations; Recruiting

Multiple Locations, China

Colombia

Many Locations; Recruiting

Multiple Locations, Colombia

Italy

Many Locations; Completed

Multiple Locations, Italy

Korea, Republic of

Many Locations; Recruiting

Multiple Locations, Korea, Republic of

Russian Federation

Many Locations; Active, not recruiting

Multiple Locations, Russian Federation

Saudi Arabia

Many Locations; Not yet recruiting

Multiple Locations, Saudi Arabia

Slovenia

Many Locations; Active, not recruiting

Multiple Locations, Slovenia

Spain

Many Locations; Recruiting

Multiple Locations, Spain

Switzerland

Many Locations; Completed

Multiple Locations, Switzerland

Taiwan

Many Locations; Recruiting

Multiple Locations, Taiwan

United Kingdom

Many Locations; Not yet recruiting

Multiple Locations, United Kingdom

Sponsors and Collaborators

Bayer

More Information

Additional Information:

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. 

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT04401761
• Other Study ID Numbers: 21283
• First Posted: May 26, 2020
• Last Update Posted: March 20, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:

Thrombosis

Additional relevant MeSH terms:

Coronary Artery Disease; Peripheral Arterial Disease; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Atherosclerosis; Peripheral Vascular Diseases; Aspirin; Rivaroxaban; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Antipyretics; Factor Xa Inhibitors; Antithrombins