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

NCT04401761 | Completed

• 1 other identifier: 21283
• Study Type: observational
• Target: 3,189
• Locations: 10 countries
• Sites: 10

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.

Conditions

Coronary Artery Disease; Peripheral Artery Disease

Keywords

Thrombosis

Outcome Measures

Primary Outcomes (14)

• 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

• Descriptive analysis of clinical characteristics of CAD participants

  At baseline

• Descriptive analysis of clinical characteristics of PAD participants

  At baseline

• Descriptive analysis of prior antithrombotic treatment

  At baseline

• Descriptive analysis of concomitant antithrombotic treatment

  Upto 34 months

• Descriptive analysis of prior secondary prevention therapies

  At baseline

• Descriptive analysis of concomitant secondary prevention therapies

  Up to 34 months

• Reason to start rivaroxaban

  Reasons include past ischemic events, co-morbidities and medical history.

  At baseline

• Decision point to start rivaroxaban

  Time point of start of medication in relation to disease progress and/ or occurrence of ischemic events

  At baseline

• Reasons for discontinuation of rivaroxaban

  Up to 34 months

• Planned duration of treatment with rivaroxaban

  At baseline

• Actual duration of treatment with rivaroxaban

  Up to 34 months

• Planned duration of treatment with Acetylsalicylic acid (ASA)

  At baseline

• Actual duration of treatment with ASA

  Up to 34 months

Secondary Outcomes (17)

• Number of participants with major adverse cardiovascular events (MACE)

  Up to 34 months

• Number of participants with major adverse limb events (MALE)

  Up to 34 months

• Number of participants with antithrombotic treatment after MALE

  Up to 34 months

• Number of participants with MACE or MALE

  Up to 34 months

• Number of participants with thromboembolic events

  Up to 34 months

Study Arms (1)

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); Drug: Acetylsalicylic acid

Interventions

Rivaroxaban (BAY59-7939, Xarelto) DRUG

2.5 mg twice daily

Also known as: Xarelto

CAD/PAD-patients

Acetylsalicylic acid DRUG

75 - 100 mg once daily at the discretion of the investigator

Also known as: Aspirin

CAD/PAD-patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

International population of adult CAD/PAD patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (10)

Many Locations

Multiple Locations, Belgium

Location

Many Locations

Multiple Locations, China

Location

Many Locations

Multiple Locations, Colombia

Location

Many Locations

Multiple Locations, Italy

Location

Many Locations

Multiple Locations, Russia

Location

Many Locations

Multiple Locations, Slovenia

Location

Many Locations

Multiple Locations, South Korea

Location

Many Locations

Multiple Locations, Spain

Location

Many Locations

Multiple Locations, Switzerland

Location

Many Locations

Multiple Locations, Taiwan

Location

Related Links

• 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.

MeSH Terms

Conditions

Coronary Artery Disease; Peripheral Arterial Disease; Thrombosis

Interventions

Rivaroxaban; Aspirin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Atherosclerosis; Peripheral Vascular Diseases; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 26, 2020
• Study Start: May 28, 2020
• Primary Completion: June 30, 2023
• Study Completion: September 29, 2023
• Last Updated: October 25, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); KR (1); IT (1); SL (1); CH (1); CN (1); RU (1); TW (1); CO (1); ES (1)