Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Gain Insights in Treatment Patterns and Outcomes in Patients With Atherosclerosis Prescribed to Xarelto in Combination With Acetylsalicylic Acid (XATOA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03746275
Recruitment Status : Recruiting
First Posted : November 19, 2018
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
Bayer

Brief Summary:
In this study researchers want to gain more information on treatment patterns of patients treated with Xarelto in combination with acetylsalicylic acid (ASA). Both drugs reduce the risk of blood clots via different pathways. The study will enroll adult patients suffering from coronary artery disease (narrowing or blockage of vessels that supply the heart with blood) or peripheral artery disease (narrowing or blockage of vessels that supply the legs or head with blood). The study will focus on information on when and why physicians are starting to treat patients with Xarelto in addition to ASA, treatment duration, reasons to discontinue treatment and previous therapies. The study will also look into treatment outcomes for patients being treated with a combination of Xarelto and ASA by their physicians.

Condition or disease Intervention/treatment
Atherosclerosis Drug: Rivaroxaban (BAY59-7939, Xarelto) Drug: Acetylsalicylic acid

Detailed Description:
The study aims to collect real-world data on treatment patterns and decision points for treatment in patients with coronary artery disease (CAD) and/ or peripheral artery disease (PAD) treated with rivaroxaban 2.5 mg [twice daily] for the prevention of major cardiovascular events in adult patients with CAD at high risk of ischemic events and/ or documented PAD and to describe outcomes of an antithrombotic regime based on dual pathway inhibition (vascular dose of rivaroxaban 2.5 mg [twice daily] plus low-dose ASA [once daily]) across the broad range of patient risk profiles encountered in routine clinical practice.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Xarelto + Acetylsalicylic Acid: Treatment Patterns and Outcomes in Patients With Atherosclerosis. A Non-interventional Study.
Actual Study Start Date : November 13, 2018
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Group/Cohort Intervention/treatment
CAD/PAD-patients
Adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) from Europe, Asia, Latin America and Canada, who are treated with a combination of rivaroxaban and acetylsalicylic acid to prevent atherothrombotic events
Drug: Rivaroxaban (BAY59-7939, Xarelto)
2.5 mg twice daily
Other Name: Xarelto

Drug: Acetylsalicylic acid
75 - 100 mg once daily according to local label
Other Name: Aspirin




Primary Outcome Measures :
  1. Descriptive analysis of patient history of CAD [ Time Frame: At baseline ]
  2. Descriptive analysis of patient history of PAD [ Time Frame: At baseline ]
  3. Descriptive analysis of prior antithrombotic treatment [ Time Frame: At baseline ]
  4. Descriptive analysis of concomitant antithrombotic treatment [ Time Frame: Up to 30.5 months ]
  5. Descriptive analysis of prior secondary prevention therapies [ Time Frame: At baseline ]
  6. Descriptive analysis of concomitant secondary prevention therapies [ Time Frame: Up to 30.5 months ]
  7. Reason for start of rivaroxaban [ Time Frame: At baseline ]
    Reasons include past ischemic events, co-morbidities and medical history.

  8. Decision point for start of rivaroxaban [ Time Frame: At baseline ]
    Time point of start of medication in relation to disease progress and/ or occurrence of ischemic events.

  9. Reason for discontinuation of rivaroxaban [ Time Frame: Up to 30.5 months ]
  10. Planned duration of treatment with rivaroxaban [ Time Frame: At baseline ]
  11. Actual duration of treatment with rivaroxaban [ Time Frame: Up to 30.5 months ]
  12. Planned duration of treatment with acetylsalicylic acid [ Time Frame: At baseline ]
  13. Actual duration of treatment with acetylsalicylic acid [ Time Frame: Up to 30.5 months ]

Secondary Outcome Measures :
  1. Occurrence of major adverse cardiac events [ Time Frame: Up to 30.5 months ]
    Composite measure of stroke, myocardial infarction and cardiovascular death

  2. Occurrence of stroke [ Time Frame: Up to 30.5 months ]
  3. Occurrence of myocardial infarction [ Time Frame: Up to 30.5 months ]
  4. Occurrence of cardiovascular death [ Time Frame: Up to 30.5 months ]
  5. Occurrence of major adverse limb events [ Time Frame: Up to 30.5 months ]
    Major adverse limb events comprise acute/severe limb ischemia including major amputation and chronic limb ischemia.

  6. Occurrence of acute/severe limb ischemia [ Time Frame: Up to 30.5 months ]
  7. Occurrence of chronic limb ischemia [ Time Frame: Up to 30.5 months ]
  8. Occurrence of major amputation [ Time Frame: Up to 30.5 months ]
  9. Anti-thrombotic treatment pattern after major adverse limb event [ Time Frame: Up to 30.5 months ]
    Treatment pattern comprises drug name, dose and duration of treatment.

  10. Occurrence of thromboembolic events [ Time Frame: Up to 30.5 months ]
    Thromboembolic events include systemic embolism and venous thromboembolism.

  11. Occurrence of haemorrhagic events [ Time Frame: Up to 30.5 months ]
    A haemorrhagic event is any event related to bleeding.

  12. Occurrence of death from cardiovascular events [ Time Frame: Up to 30.5 months ]
  13. Occurrence of death from any cause [ Time Frame: Up to 30.5 months ]
  14. Occurrence of cardiac revascularization procedures [ Time Frame: Up to 30.5 months ]
    Includes percutaneous coronary intervention and coronary artery bypass grafting.

  15. Occurrence of peripheral revascularization procedures [ Time Frame: Up to 30.5 months ]
  16. Occurrence of carotid revascularization procedures [ Time Frame: Up to 30.5 months ]
  17. Occurrence of hospitalizations [ Time Frame: Up to 30.5 months ]
    Hospitalizations due to stroke, cardiovascular reasons, major adverse limb events or bleeding complications.

  18. Duration of hospitalization [ Time Frame: Up to 30.5 months ]
    Time in days of hospitalization due to stroke, cardiovascular reasons, major adverse limb events or bleeding complications.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults in routine medical practice, multi-national
Criteria

Inclusion Criteria:

  • Adults with diagnosis Coronary Artery Disease (CAD) or Peripheral Artery Disease (PAD).
  • Treatment according to local marketing authorization, rivaroxaban 2.5 mg twice daily started within 4 weeks prior to enrolment. Only in those countries with a marketing authorization of rivaroxaban in the acute coronary syndrome (ACS) indication, also patients already on rivaroxaban treatment for ACS, who are subsequently fulfilling criteria for CAD, are allowed to be enrolled within 4 weeks of this decision being made.

Exclusion Criteria:

  • Patients who will be treated with chronic anticoagulation therapy other than rivaroxaban 2.5 mg given for CAD/PAD.
  • Participation in an interventional trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03746275


Contacts
Layout table for location contacts
Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

  Show 22 Study Locations
Sponsors and Collaborators
Bayer
Janssen, LP

Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03746275     History of Changes
Other Study ID Numbers: 20280
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Coronary artery disease (CAD)
Peripheral artery disease (PAD)
Major adverse limb events (MALE)
Major adverse cardiac events (MACE)
Atherosclerosis
Atherothrombosis
Thrombosis
Embolism
Thromboembolism

Additional relevant MeSH terms:
Layout table for MeSH terms
Anticoagulants
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Rivaroxaban
Aspirin
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Antipyretics