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)

NCT03887780 | Completed

• 1 other identifier: 20387
• Study Type: observational
• Target: 504
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-valvular Atrial Fibrillation (NVAF)

Keywords

Stroke;; Systemic embolism

Outcome Measures

Primary Outcomes (4)

• Incidence of major bleeding events

  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.

  Up to 18 months

• Incidence of treatment-emergent AEs

  Up to 18 months

• Incidence of treatment-emergent SAEs

  Up to 18 months

• Incidence of all-cause death

  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).

  Up to 18 months

Secondary Outcomes (5)

• Incidence of symptomatic thromboembolic events

  Up to 18 months

• Non-major bleeding events

  Up to 18 months

• AE rates in the different NVAF risk factor categories

  Up to 18 months

• SAE rates in the different NVAF risk factor categories

  Up to 18 months

• Treatment persistence with rivaroxaban

  Up to 18 months

Study Arms (1)

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)

Interventions

Rivaroxaban (Xarelto,Bay 59-7939) DRUG

15 mg and 20 mg (OD)

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead
• Janssen Research & Development, LLC: collaborator

Study Sites (1)

Sunshine Hospital

Secunderabad, National Capital Territory of Delhi, 500003, India

Location

Related Links

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MeSH Terms

Conditions

Stroke

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

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

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 25, 2019
• Study Start: October 3, 2019
• Primary Completion: December 23, 2023
• Study Completion: December 16, 2024
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)