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)

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 504 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
DRUG	Rivaroxaban (Xarelto,Bay 59-7939)	15 mg and 20 mg (OD)

Timeline

• Start date: 2019-10-03
• Primary completion: 2023-12-23
• Completion: 2024-12-16
• First posted: 2019-03-25
• Last updated: 2025-01-08

Locations

1 site across 1 country: India