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Completed

NCT Number: NCT03887780

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)

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.

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Key information

Conditions

Non-valvular Atrial Fibrillation (NVAF) Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sunshine Hospital

Secunderabad, National Capital Territory of Delhi, 500003, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rivaroxaban (Xarelto,Bay 59-7939)

Drug

15 mg and 20 mg (OD)

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study 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)

Acronym: XARIN

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Mar 25, 2019
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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