Clinical trial NCT04401761: 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
Official title: Xarelto + Acetylsalicylic Acid: Treatment Patterns and Outcomes Across the Disease Continuum in Patients With CAD and/or PAD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Peripheral Artery Disease
Keywords: Thrombosis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-05-26
Enrollment: 3189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: International population of adult CAD/PAD patients

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.


Eligibility 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.

Primary outcomes:
measure: Health status by questionnaire EQ-5D-5L
timeFrame: Up to 34 months
measure: Descriptive analysis of clinical characteristics of CAD participants
timeFrame: At baseline
measure: Descriptive analysis of clinical characteristics of PAD participants
timeFrame: At baseline
measure: Descriptive analysis of prior antithrombotic treatment
timeFrame: At baseline
measure: Descriptive analysis of concomitant antithrombotic treatment
timeFrame: Upto 34 months
measure: Descriptive analysis of prior secondary prevention therapies
timeFrame: At baseline
measure: Descriptive analysis of concomitant secondary prevention therapies
timeFrame: Up to 34 months
measure: Reason to start rivaroxaban
timeFrame: At baseline
measure: Decision point to start rivaroxaban
timeFrame: At baseline
measure: Reasons for discontinuation of rivaroxaban
timeFrame: Up to 34 months
measure: Planned duration of treatment with rivaroxaban
timeFrame: At baseline
measure: Actual duration of treatment with rivaroxaban
timeFrame: Up to 34 months
measure: Planned duration of treatment with Acetylsalicylic acid (ASA)
timeFrame: At baseline
measure: Actual duration of treatment with ASA
timeFrame: Up to 34 months
Secondary outcomes:
measure: Number of participants with major adverse cardiovascular events (MACE)
timeFrame: Up to 34 months
measure: Number of participants with major adverse limb events (MALE)
timeFrame: Up to 34 months
measure: Number of participants with antithrombotic treatment after MALE
timeFrame: Up to 34 months
measure: Number of participants with MACE or MALE
timeFrame: Up to 34 months
measure: Number of participants with thromboembolic events
timeFrame: Up to 34 months
measure: Number of participants with haemorrhagic events and complications
timeFrame: Up to 34 months
measure: Number of deaths due to cardiovascular events
timeFrame: Up to 34 months
measure: Number of deaths due to any cause
timeFrame: Up to 34 months
measure: Number of participants with cardiac revascularization procedures
timeFrame: Up to 34 months
measure: Number of participants with peripheral revascularization procedures
timeFrame: Up to 34 months
measure: Number of participants with lower limb revascularization procedures.
timeFrame: Up to 34 months
measure: Number of participants with carotid revascularization procedures
timeFrame: Up to 34 months
measure: Number of hospitalizations
timeFrame: Up to 34 months
measure: Duration of hospitalizations
timeFrame: Up to 34 months
measure: Total walking distance per individual for PAD participants
timeFrame: Up to 34 months
measure: Pain free walking distance per individual for PAD participants
timeFrame: Up to 34 months
measure: Patient-reported walking impairment by Walking Impairment Questionnaire (WIQ) for PAD participants
timeFrame: Up to 34 months
Other outcomes:
Locations:
city: Multiple Locations
country: Belgium
facility: Many Locations
city: Multiple Locations
country: China
facility: Many Locations
city: Multiple Locations
country: Colombia
facility: Many Locations
city: Multiple Locations
country: Italy
facility: Many Locations
city: Multiple Locations
country: Korea, Republic of
facility: Many Locations
city: Multiple Locations
country: Russian Federation
facility: Many Locations
city: Multiple Locations
country: Slovenia
facility: Many Locations
city: Multiple Locations
country: Spain
facility: Many Locations
city: Multiple Locations
country: Switzerland
facility: Many Locations
city: Multiple Locations
country: Taiwan
facility: Many Locations
Study officials:
References: