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
- Conditions
- Coronary Artery DiseasePeripheral Artery Disease
- Interventions
- Registration Number
- NCT04401761
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3189
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CAD/PAD-patients Rivaroxaban (BAY59-7939, Xarelto) Adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) who are treated with a combination of rivaroxaban and acetylsalicylic acid. CAD/PAD-patients Acetylsalicylic acid Adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) who are treated with a combination of rivaroxaban and acetylsalicylic acid.
- Primary Outcome Measures
Name Time Method Descriptive analysis of concomitant antithrombotic treatment Upto 34 months Planned duration of treatment with rivaroxaban At baseline Health status by questionnaire EQ-5D-5L 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).
Descriptive analysis of clinical characteristics of CAD participants At baseline Actual duration of treatment with ASA Up to 34 months Descriptive analysis of clinical characteristics of PAD participants At baseline Descriptive analysis of prior antithrombotic treatment At baseline Descriptive analysis of prior secondary prevention therapies At baseline Descriptive analysis of concomitant secondary prevention therapies Up to 34 months Decision point to start rivaroxaban At baseline Time point of start of medication in relation to disease progress and/ or occurrence of ischemic events
Reasons for discontinuation of rivaroxaban Up to 34 months Reason to start rivaroxaban At baseline Reasons include past ischemic events, co-morbidities and medical history.
Actual duration of treatment with rivaroxaban Up to 34 months Planned duration of treatment with Acetylsalicylic acid (ASA) At baseline
- Secondary Outcome Measures
Name Time Method Patient-reported walking impairment by Walking Impairment Questionnaire (WIQ) for PAD participants 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).
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 Number of participants with peripheral revascularization procedures 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 major adverse cardiovascular events (MACE) Up to 34 months Composite endpoint comprising of myocardial infarction, stroke, and cardiovascular death (and single components).
Number of participants with carotid revascularization procedures Up to 34 months Number of participants with lower limb revascularization procedures. Up to 34 months Number of participants with major adverse limb events (MALE) Up to 34 months Major adverse limb events comprise acute limb ischemia and vascular amputation, and antithrombotic treatment \[pattern\] after MALE.
Number of participants with cardiac revascularization procedures Up to 34 months Cardiac revascularization procedure includes Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG)
Number of participants with antithrombotic treatment after MALE Up to 34 months Number of hospitalizations Up to 34 months Number of hospitalizations due to stroke, cardiovascular reasons, MALE, or bleeding complications.
Number of participants with MACE or MALE Up to 34 months Composite endpoint comprising myocardial infarction, ischemic stroke, cardiovascular death, acute limb ischemia, major amputation of vascular etiology.
Number of participants with thromboembolic events Up to 34 months Thromboembolic events include e.g. systemic embolism and venous thromboembolism.
Number of participants with haemorrhagic events and complications 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.
Duration of hospitalizations Up to 34 months Hospitalizations due to stroke, cardiovascular reasons, MALE, or bleeding complications.
Trial Locations
- Locations (1)
Many Locations
🇨🇳Multiple Locations, Taiwan