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A Study to Evaluate the Safety and Effectiveness of Rivaroxaban (Xarelto) for Prevention of Stroke and Systemic Embolism in Indian Patients With Non-valvular Atrial Fibrillation (NVAF) (XARIN)

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ClinicalTrials.gov Identifier: NCT03887780
Recruitment Status : Not yet recruiting
First Posted : March 25, 2019
Last Update Posted : April 24, 2019
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer

Brief Summary:

This study is planned to collect prospective data and evaluate the safety and effectiveness of rivaroxaban for the prevention of stroke and systemic embolism in Indian patients with NVAF when used in clinical practice under real-life conditions.

The study will be conducted in routine clinical practice settings. Approximately 1000 patients from India will be enrolled in this study. Patients will be observed for maximum period of 12 months after the start of Xarelto treatment or until it is no longer possible (e.g. lost to follow-up, death, withdrawal) before the end of the observation period.

The decision by the investigator to start with of Xarelto must be independent of the inclusion of a patient to the study.


Condition or disease Intervention/treatment
Non-valvular Atrial Fibrillation (NVAF) Drug: Rivaroxaban (Xarelto,Bay 59-7939)

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Real-World, Prospective, Observational Study to Evaluate the Safety and Effectiveness of Rivaroxaban (Xarelto®) for Prevention of Stroke and Systemic Embolism in Indian Patients With Non-valvular Atrial Fibrillation (NVAF)
Estimated Study Start Date : April 30, 2019
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Group/Cohort Intervention/treatment
Treatment
Rivaroxaban treatment-naïve patients, at least 18 years of age and presenting with NVAF will be considered eligible for participation in this study only after the decision to treat with rivaroxaban has been made by the treating physician.
Drug: Rivaroxaban (Xarelto,Bay 59-7939)
15 mg and 20 mg (OD)




Primary Outcome Measures :
  1. Incidence of major bleeding events [ Time Frame: Up to 18 months ]

    Major bleeding events include:

    • Fatal bleeding
    • Symptomatic bleeding in a critical area or organ
    • Bleeding causing a fall in hemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.

      • Hemoglobin level; or
      • Need for transfusion of packed red blood cells or whole blood.

  2. Incidence of treatment-emergent AEs [ Time Frame: Up to 18 months ]
  3. Incidence of treatment-emergent SAEs [ Time Frame: Up to 18 months ]
  4. Incidence of all-cause death [ Time Frame: Up to 18 months ]
    Deaths will be adjudicated as either vascular (e.g., due to stroke, embolism, myocardial infarction, or arrhythmia) or non-vascular (e.g., malignancy or infection).


Secondary Outcome Measures :
  1. Incidence of symptomatic thromboembolic events [ Time Frame: Up to 18 months ]

    The date of thromboembolic events, manner in which thromboembolic events were managed in the routine practice setting, and their outcomes will be recorded.

    The thromboembolic events include:

    • Stroke and transient ischemic attack (TIA)
    • Systemic embolism
    • Myocardial infarction

  2. Non-major bleeding events [ Time Frame: Up to 18 months ]
    The date of non-major bleeding events, treatment approaches employed during non-major bleeding events, and the associated outcomes will be collected.

  3. AE rates in the different NVAF risk factor categories [ Time Frame: Up to 18 months ]
    Rates of AEs across patients with different baseline risk profiles for stroke or bleeding calculated using Congestive heart failure, Hypertension, Age, Diabetes mellitus, Stroke(CHADS2), Vascular disease, Age, Sex category (CHA2DS2-VASc), or Hypertension, Abnormal liver/renal function, Stroke history, Bleeding predisposition, Labile international normalized ratios, Elderly, Drug/alcohol usage (HAS-BLED).

  4. SAE rates in the different NVAF risk factor categories [ Time Frame: Up to 18 months ]
    Rates of SAEs across patients with different baseline risk profiles for stroke or bleeding calculated using Congestive heart failure, Hypertension, Age, Diabetes mellitus, Stroke (CHADS2), Vascular disease, Age, Sex category (CHA2DS2-VASc), or Hypertension, Abnormal liver/renal function, Stroke history, Bleeding predisposition, Labile international normalized ratios, Elderly, Drug/alcohol usage (HAS-BLED).

  5. Treatment persistence with rivaroxaban [ Time Frame: Up to 18 months ]
    Treatment persistence with rivaroxaban therapy will be defined as the absence of a gap of >60 days between two doses of rivaroxaban, without any switch to alternative anticoagulant. Reasons for any switch from or interruption of rivaroxaban therapy during the observation period will be collected and summarized.



Information from the National Library of Medicine

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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
Female and male patients ≥18 years of age with a diagnosis of NVAF will be enrolled only after the decision for treatment with rivaroxaban has been made by the investigator.
Criteria

Inclusion Criteria:

  • Patient should be an adult female or male, ≥18 years of age;
  • Patient should be diagnosed with NVAF and initiated with rivaroxaban treatment for prevention of stroke or systemic embolism per investigator's routine treatment practice;
  • Patient should not have received rivaroxaban in the past;
  • Patient/patient's legally acceptable representative should be willing to provide written informed consent;

Exclusion Criteria:

  • Patient has contraindications to receive rivaroxaban therapy according to local prescribing information;
  • Patient is receiving anticoagulant therapy for indication other than NVAF and that needs to be continued as per discretion of treating physician;
  • Patient is participating in an investigational program with interventions outside of routine clinical practice.

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): NCT03887780


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

Locations
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India
Many locations Not yet recruiting
Multiple Locations, India
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03887780     History of Changes
Other Study ID Numbers: 20387
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Availability of this study's data will 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Stroke;
Systemic embolism

Additional relevant MeSH terms:
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Atrial Fibrillation
Embolism
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants