CompletedNot Applicable

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)

India504 participantsStarted 2019-10-03

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Incidence of major bleeding events

Timeframe: Up to 18 months

Incidence of treatment-emergent AEs

Timeframe: Up to 18 months

Incidence of treatment-emergent SAEs

Timeframe: Up to 18 months

Incidence of all-cause death

Timeframe: Up to 18 months

Trial details

NCT IDNCT03887780

SponsorBayer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-12-23

View on ClinicalTrials.gov More Non-valvular Atrial Fibrillation (NVAF) trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.