NCT03887780Completed
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)
Source: ClinicalTrials.gov · Last updated 8 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 504 (actual)
- First submitted
- 21 Mar 2019
- Start date
- 3 Oct 2019
- Primary completion date
- 23 Dec 2023
- Lead sponsor
- Bayer
- Diseases
- Stroke, Atrial fibrillation
- NCT number
- NCT03887780
What you commit to
- Study type: Observational
- Participants enrolled: 504
- From 3 Oct 2019 to the primary completion date, 23 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other
- Patient is participating in an investigational program with interventions outside of routine clinical practice.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sunshine Hospital Coordinator of this site? Confirm its status | Secunderabad | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.