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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

504 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-03

Study Completion Date

2024-12-16

Brief Summary

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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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Detailed Description

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Conditions

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Non-valvular Atrial Fibrillation (NVAF)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Rivaroxaban (Xarelto,Bay 59-7939)

Intervention Type DRUG

15 mg and 20 mg (OD)

Interventions

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Rivaroxaban (Xarelto,Bay 59-7939)

15 mg and 20 mg (OD)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No