A study to evaluate safety and effectiveness of Rivaroxaban (XareltoÂ®) 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 (XareltoÂ®) for Prevention of Stroke and Systemic Embolism in Indian Patients with Non-valvular Atrial Fibrillation (NVAF) - XARIN

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2019/09/021158

Enrollment

1000

Registered

2019-09-09

Start date

Unknown

Completion date

Unknown

Last updated

2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I489- Unspecified atrial fibrillation and atrial flutter

Interventions

None listed

Eligibility

Inclusion 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 investigatorâ??s routine treatment practice; • Patient should not have received rivaroxaban in the past; • Patient/patientâ??s legally acceptable representative should be willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patient has contraindications to receive rivaroxaban therapy according to local prescribing information; 2. Patient is receiving anticoagulant therapy for indication other than NVAF and that needs to be continued as per discretion of treating physician; 3. Patient is participating in an investigational program with interventions outside of routine clinical practice.

Design outcomes

Primary

Measure	Time frame
1 Incidence of major bleeding events, defined using International Society on Thrombosis and Hemostasis Criteria 2 Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) 3 Incidence of all-cause death.Timepoint: After 18 Months that is after the completion of study	—

Secondary

Measure	Time frame
1. Incidence of symptomatic thromboembolic events including stroke, TIA, systemic embolism, myocardial infarction, pulmonary embolism, deep vein thrombosis, atrial thrombus; 2. Non-major bleeding events; 3. AE and SAE rates in the different NVAF risk factor categories 4. Treatment persistence with rivaroxaban with different co-morbidities and risk profile.Timepoint: 1 The date of thromboembolic events, manner in which thromboembolic events were managed in the routine practice setting, and their outcomes will be recorded. This will include any use of thrombolytics or surgical intervention after ischemia. 2 The date of non-major bleeding events. 3 Rates of AEs and SAEs across patients with different baseline risk profiles for stroke or bleeding calculated using CHADS2, CHA2DS2-VASc,	—

Measure

Time frame

1. Incidence of symptomatic thromboembolic events including stroke, TIA, systemic embolism, myocardial infarction, pulmonary embolism, deep vein thrombosis, atrial thrombus; 2. Non-major bleeding events; 3. AE and SAE rates in the different NVAF risk factor categories 4. Treatment persistence with rivaroxaban with different co-morbidities and risk profile.Timepoint: 1 The date of thromboembolic events, manner in which thromboembolic events were managed in the routine practice setting, and their outcomes will be recorded. This will include any use of thrombolytics or surgical intervention after ischemia. 2 The date of non-major bleeding events. 3 Rates of AEs and SAEs across patients with different baseline risk profiles for stroke or bleeding calculated using CHADS2, CHA2DS2-VASc,

—

Countries

India

Contacts

Public ContactDr Pravin Manjrekar

Bayer Zydus Pharma Private Limited

pravin.manjrekar@bayerzyduspharma.com91-22-2531-1486

Outcome results