Clinical trial 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)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-valvular Atrial Fibrillation (NVAF)
Keywords: Stroke;
Systemic embolism
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2019-03-25
Enrollment: 504
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of major bleeding events
timeFrame: Up to 18 months
measure: Incidence of treatment-emergent AEs
timeFrame: Up to 18 months
measure: Incidence of treatment-emergent SAEs
timeFrame: Up to 18 months
measure: Incidence of all-cause death
timeFrame: Up to 18 months
Secondary outcomes:
measure: Incidence of symptomatic thromboembolic events
timeFrame: Up to 18 months
measure: Non-major bleeding events
timeFrame: Up to 18 months
measure: AE rates in the different NVAF risk factor categories
timeFrame: Up to 18 months
measure: SAE rates in the different NVAF risk factor categories
timeFrame: Up to 18 months
measure: Treatment persistence with rivaroxaban
timeFrame: Up to 18 months
Other outcomes:
Locations:
city: Secunderabad
country: India
facility: Sunshine Hospital
state: Delhi
Study officials:
References: