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)

Active, not recruiting

• Conditions: Non-valvular Atrial Fibrillation (NVAF)
• Interventions: Drug: Rivaroxaban (Xarelto,Bay 59-7939)

• Registration Number: NCT03887780
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2019-03-21
• Study First Submitted QC: 2019-03-21
• Study First Posted: 2019-03-25
• Study Start: 2019-10-03
• Primary Completion: 2023-12-23
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-10
• Study Completion: 2024-12-16

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 504

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.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment	Rivaroxaban (Xarelto,Bay 59-7939)	Rivaroxaban treatment-naïve patients, at least 18 years of age and presenting with NVAF will be considered eligible for participation in this study only after the decision to treat with rivaroxaban has been made by the treating physician.

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent AEs	Up to 18 months
Incidence of all-cause death	Up to 18 months	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).
Incidence of major bleeding events	Up to 18 months	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.
Incidence of treatment-emergent SAEs	Up to 18 months

Secondary Outcome Measures

Name	Time	Method
Non-major bleeding events	Up to 18 months	The date of non-major bleeding events, treatment approaches employed during non-major bleeding events, and the associated outcomes will be collected.
AE rates in the different NVAF risk factor categories	Up to 18 months	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).
Incidence of symptomatic thromboembolic events	Up to 18 months	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
Treatment persistence with rivaroxaban	Up to 18 months	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.
SAE rates in the different NVAF risk factor categories	Up to 18 months	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).

Trial Locations

Locations (1)

Sunshine Hospital; 🇮🇳 Secunderabad, Delhi, India