check_circleStudy Completed
Non-valvular atrial fibrillation (NVAF)
Bayer Identifier:
20387
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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)
Trial purpose
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.
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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
504Trial Dates
October 2019 - December 2024Phase
Phase 4Could I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Sunshine Hospital | Secunderabad, 500003, India |
Withdrawn | Shree Mahavir Health & Medical Society Shri Bachubhai Dahyab | Surat, 395001, India |
Withdrawn | Apollo Gleneagles Hospital Limited | Kolkata, 700054, India |
Withdrawn | Batra Hospital and Medical Research Centre (BHMRC) | New Delhi, 110062, India |
Withdrawn | Apollo Hospitals | Chennai, 600006, India |
Withdrawn | Divine Heart and Multispeciality Hospital | Lucknow, 226010, India |
Withdrawn | Fortis Hospital Bangalore | Bengaluru, 560076, India |
Withdrawn | Anand Multispeciality Hospital | Vadodara, 390016, India |
Withdrawn | M. S. Ramaiyah Medical College Hospital | Bangalore, 560054, India |
Withdrawn | Sri Ramachandra Institute of Higher Education and Research | Chennai, 600116, India |
Withdrawn | Zydus Hospitals and Healthcare Research Private Limited | Ahmedabad, 380054, India |
Withdrawn | Krishna Institute Of Medical Science | Secunderabad, 500 003, India |
Withdrawn | Paritosha Foundation | Mumbai, 400086, India |
Withdrawn | Yashoda Hospitals, Hyderabad | Hyderabad, 500082, India |
Withdrawn | Eternal Hospital | Jaipur, 302017, India |
Withdrawn | Columbia Asia Referral Hospital Yeshwanthpur | Bangalore, 560055, India |
Withdrawn | MIOT International | Chennai, 600089, India |
Withdrawn | Bhaktivedanta Hospital & Research Institute | Thane, 401107, India |
Withdrawn | Lisie Hospital | Kochi, 682017, India |
Withdrawn | Fortis Hospital | Mohali, 160062, India |
Withdrawn | Fortis Flt. Lt. Rajan Dhall Hospital | New Delhi, 110070, India |
Withdrawn | Fortis Hospital | West Mumbai, 400078, India |
Withdrawn | Vijan Hospital & Research Centre | Nashik, 422005, India |
Withdrawn | Joshi Hospital | Pune, 411004, India |
Withdrawn | Dr. B. L. Kapur Memorial Hospital | New Delhi, 110005, India |
Withdrawn | Apollo Hospitals | Mumbai, 400614, India |
Withdrawn | HCG Hospitals, Ahmedabad | Ahmedabad, 380006, India |
Primary Outcome
- Incidence of major bleeding eventsMajor 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.date_rangeTime Frame:Up to 18 months
- Incidence of treatment-emergent AEsdate_rangeTime Frame:Up to 18 months
- Incidence of treatment-emergent SAEsdate_rangeTime Frame:Up to 18 months
- Incidence of all-cause deathDeaths will be adjudicated as either vascular (e.g., due to stroke, embolism, myocardial infarction, or arrhythmia) or non-vascular (e.g., malignancy or infection).date_rangeTime Frame:Up to 18 months
Secondary Outcome
- Incidence of symptomatic thromboembolic eventsThe 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 infarctiondate_rangeTime Frame:Up to 18 months
- Non-major bleeding eventsThe date of non-major bleeding events, treatment approaches employed during non-major bleeding events, and the associated outcomes will be collected.date_rangeTime Frame:Up to 18 months
- AE rates in the different NVAF risk factor categoriesRates 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).date_rangeTime Frame:Up to 18 months
- SAE rates in the different NVAF risk factor categoriesRates 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).date_rangeTime Frame:Up to 18 months
- Treatment persistence with rivaroxabanTreatment 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.date_rangeTime Frame:Up to 18 months
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A