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)

Non-valvular Atrial Fibrillation (NVAF) Clinical Trial

— XARIN  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03887780
• Other study ID #: 20387
• Status: Active, not recruiting
• Start date: October 3, 2019
• Est. completion date: May 31, 2024

Study information

• Verified date: April 2024
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 504
• Est. completion date: May 31, 2024
• Est. primary completion date: December 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Embolism
• Non-valvular Atrial Fibrillation (NVAF)

Intervention

Drug:
• Rivaroxaban (Xarelto,Bay 59-7939)
15 mg and 20 mg (OD)

Locations

Country	Name	City	State
India	Sunshine Hospital	Secunderabad	Delhi

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of major bleeding events	Major bleeding events include: Fatal bleeding; Symptomatic bleeding in a critical area or organ; Bleeding causing a fall in hemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.; Hemoglobin level; or; Need for transfusion of packed red blood cells or whole blood.	Up to 18 months
Primary	Incidence of treatment-emergent AEs		Up to 18 months
Primary	Incidence of treatment-emergent SAEs		Up to 18 months
Primary	Incidence of all-cause death	Deaths will be adjudicated as either vascular (e.g., due to stroke, embolism, myocardial infarction, or arrhythmia) or non-vascular (e.g., malignancy or infection).	Up to 18 months
Secondary	Incidence of symptomatic thromboembolic events	The date of thromboembolic events, manner in which thromboembolic events were managed in the routine practice setting, and their outcomes will be recorded.; The thromboembolic events include: Stroke and transient ischemic attack (TIA); Systemic embolism; Myocardial infarction	Up to 18 months
Secondary	Non-major bleeding events	The date of non-major bleeding events, treatment approaches employed during non-major bleeding events, and the associated outcomes will be collected.	Up to 18 months
Secondary	AE rates in the different NVAF risk factor categories	Rates of AEs across patients with different baseline risk profiles for stroke or bleeding calculated using Congestive heart failure, Hypertension, Age, Diabetes mellitus, Stroke(CHADS2), Vascular disease, Age, Sex category (CHA2DS2-VASc), or Hypertension, Abnormal liver/renal function, Stroke history, Bleeding predisposition, Labile international normalized ratios, Elderly, Drug/alcohol usage (HAS-BLED).	Up to 18 months
Secondary	SAE rates in the different NVAF risk factor categories	Rates of SAEs across patients with different baseline risk profiles for stroke or bleeding calculated using Congestive heart failure, Hypertension, Age, Diabetes mellitus, Stroke (CHADS2), Vascular disease, Age, Sex category (CHA2DS2-VASc), or Hypertension, Abnormal liver/renal function, Stroke history, Bleeding predisposition, Labile international normalized ratios, Elderly, Drug/alcohol usage (HAS-BLED).	Up to 18 months
Secondary	Treatment persistence with rivaroxaban	Treatment persistence with rivaroxaban therapy will be defined as the absence of a gap of >60 days between two doses of rivaroxaban, without any switch to alternative anticoagulant. Reasons for any switch from or interruption of rivaroxaban therapy during the observation period will be collected and summarized.	Up to 18 months

External Links

•   Click here for access to information about Bayer's transparency standards and Bayer studies.