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

Coronary Artery Disease Clinical Trial

— XATOC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04401761
• Other study ID #: 21283
• Status: Completed
• Start date: May 28, 2020
• Est. completion date: September 29, 2023

Study information

• Verified date: October 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3189
• Est. completion date: September 29, 2023
• Est. primary completion date: June 30, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Drug:
• Rivaroxaban (BAY59-7939, Xarelto)
2.5 mg twice daily
• Acetylsalicylic acid
75 - 100 mg once daily at the discretion of the investigator

Locations

Country	Name	City	State
Belgium	Many Locations	Multiple Locations
China	Many Locations	Multiple Locations
Colombia	Many Locations	Multiple Locations
Italy	Many Locations	Multiple Locations
Korea, Republic of	Many Locations	Multiple Locations
Russian Federation	Many Locations	Multiple Locations
Slovenia	Many Locations	Multiple Locations
Spain	Many Locations	Multiple Locations
Switzerland	Many Locations	Multiple Locations
Taiwan	Many Locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Belgium,  China,  Colombia,  Italy,  Korea, Republic of,  Russian Federation,  Slovenia,  Spain,  Switzerland,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Descriptive analysis of clinical characteristics of CAD participants		At baseline
Primary	Descriptive analysis of clinical characteristics of PAD participants		At baseline
Primary	Descriptive analysis of prior antithrombotic treatment		At baseline
Primary	Descriptive analysis of concomitant antithrombotic treatment		Upto 34 months
Primary	Descriptive analysis of prior secondary prevention therapies		At baseline
Primary	Descriptive analysis of concomitant secondary prevention therapies		Up to 34 months
Primary	Reason to start rivaroxaban	Reasons include past ischemic events, co-morbidities and medical history.	At baseline
Primary	Decision point to start rivaroxaban	Time point of start of medication in relation to disease progress and/ or occurrence of ischemic events	At baseline
Primary	Reasons for discontinuation of rivaroxaban		Up to 34 months
Primary	Planned duration of treatment with rivaroxaban		At baseline
Primary	Actual duration of treatment with rivaroxaban		Up to 34 months
Primary	Planned duration of treatment with Acetylsalicylic acid (ASA)		At baseline
Primary	Actual duration of treatment with ASA		Up to 34 months
Secondary	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
Secondary	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
Secondary	Number of participants with antithrombotic treatment after MALE		Up to 34 months
Secondary	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
Secondary	Number of participants with thromboembolic events	Thromboembolic events include e.g. systemic embolism and venous thromboembolism.	Up to 34 months
Secondary	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
Secondary	Number of deaths due to cardiovascular events		Up to 34 months
Secondary	Number of deaths due to any cause		Up to 34 months
Secondary	Number of participants with cardiac revascularization procedures	Cardiac revascularization procedure includes Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG)	Up to 34 months
Secondary	Number of participants with peripheral revascularization procedures		Up to 34 months
Secondary	Number of participants with lower limb revascularization procedures.		Up to 34 months
Secondary	Number of participants with carotid revascularization procedures		Up to 34 months
Secondary	Number of hospitalizations	Number of hospitalizations due to stroke, cardiovascular reasons, MALE, or bleeding complications.	Up to 34 months
Secondary	Duration of hospitalizations	Hospitalizations due to stroke, cardiovascular reasons, MALE, or bleeding complications.	Up to 34 months
Secondary	Total walking distance per individual for PAD participants		Up to 34 months
Secondary	Pain free walking distance per individual for PAD participants		Up to 34 months
Secondary	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

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