An observational study in Coronary Artery Disease and Peripheral Artery Disease, sponsored by Bayer. Completed at 10 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-25.
Sponsored by Bayer · Observational
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.
5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.
This study's enrollment of 3,189 is above the median of 335 across 1,978 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Bayer is the lead sponsor of 1,674 studies on the registry; 54 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 130 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
International population of adult CAD/PAD patients
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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) · Drug: Acetylsalicylic acid
2.5 mg twice daily
Also known as: Xarelto
75 - 100 mg once daily at the discretion of the investigator
Also known as: Aspirin
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).
Time frame: Up to 34 months
Descriptive analysis of clinical characteristics of CAD participants
Time frame: At baseline
Descriptive analysis of clinical characteristics of PAD participants
Time frame: At baseline
Descriptive analysis of prior antithrombotic treatment
Time frame: At baseline
Descriptive analysis of concomitant antithrombotic treatment
Time frame: Upto 34 months
Descriptive analysis of prior secondary prevention therapies
Time frame: At baseline
Descriptive analysis of concomitant secondary prevention therapies
Time frame: Up to 34 months
Reason to start rivaroxaban
Reasons include past ischemic events, co-morbidities and medical history.
Time frame: At baseline
Decision point to start rivaroxaban
Time point of start of medication in relation to disease progress and/ or occurrence of ischemic events
Time frame: At baseline
Reasons for discontinuation of rivaroxaban
Time frame: Up to 34 months
Planned duration of treatment with rivaroxaban
Time frame: At baseline
Actual duration of treatment with rivaroxaban
Time frame: Up to 34 months
Planned duration of treatment with Acetylsalicylic acid (ASA)
Time frame: At baseline
Actual duration of treatment with ASA
Time frame: Up to 34 months
Number of participants with major adverse cardiovascular events (MACE)
Composite endpoint comprising of myocardial infarction, stroke, and cardiovascular death (and single components).
Time frame: 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.
Time frame: Up to 34 months
Number of participants with antithrombotic treatment after MALE
Time frame: 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.
Time frame: Up to 34 months
Number of participants with thromboembolic events
Thromboembolic events include e.g. systemic embolism and venous thromboembolism.
Time frame: 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.
Time frame: Up to 34 months
Number of deaths due to cardiovascular events
Time frame: Up to 34 months
Number of deaths due to any cause
Time frame: Up to 34 months
Number of participants with cardiac revascularization procedures
Cardiac revascularization procedure includes Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG)
Time frame: Up to 34 months
Number of participants with peripheral revascularization procedures
Time frame: Up to 34 months
Number of participants with lower limb revascularization procedures.
Time frame: Up to 34 months
Number of participants with carotid revascularization procedures
Time frame: Up to 34 months
Number of hospitalizations
Number of hospitalizations due to stroke, cardiovascular reasons, MALE, or bleeding complications.
Time frame: Up to 34 months
Duration of hospitalizations
Hospitalizations due to stroke, cardiovascular reasons, MALE, or bleeding complications.
Time frame: Up to 34 months
Total walking distance per individual for PAD participants
Time frame: Up to 34 months
Pain free walking distance per individual for PAD participants
Time frame: 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).
Time frame: Up to 34 months
Plan to share: No — 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.
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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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