check_circleStudy Completed

Non-valvular atrial fibrillation (NVAF)

Bayer Identifier:

20387

ClinicalTrials.gov Identifier:

NCT03887780

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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.

  • - 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.

Trial summary

Enrollment Goal
504
Trial Dates
October 2019 - December 2024
Phase
Phase 4
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Sunshine HospitalSecunderabad, 500003, India
Withdrawn
Shree Mahavir Health & Medical Society Shri Bachubhai DahyabSurat, 395001, India
Withdrawn
Apollo Gleneagles Hospital LimitedKolkata, 700054, India
Withdrawn
Batra Hospital and Medical Research Centre (BHMRC)New Delhi, 110062, India
Withdrawn
Apollo HospitalsChennai, 600006, India
Withdrawn
Divine Heart and Multispeciality HospitalLucknow, 226010, India
Withdrawn
Fortis Hospital BangaloreBengaluru, 560076, India
Withdrawn
Anand Multispeciality HospitalVadodara, 390016, India
Withdrawn
M. S. Ramaiyah Medical College HospitalBangalore, 560054, India
Withdrawn
Sri Ramachandra Institute of Higher Education and ResearchChennai, 600116, India
Withdrawn
Zydus Hospitals and Healthcare Research Private LimitedAhmedabad, 380054, India
Withdrawn
Krishna Institute Of Medical ScienceSecunderabad, 500 003, India
Withdrawn
Paritosha FoundationMumbai, 400086, India
Withdrawn
Yashoda Hospitals, HyderabadHyderabad, 500082, India
Withdrawn
Eternal HospitalJaipur, 302017, India
Withdrawn
Columbia Asia Referral Hospital YeshwanthpurBangalore, 560055, India
Withdrawn
MIOT InternationalChennai, 600089, India
Withdrawn
Bhaktivedanta Hospital & Research InstituteThane, 401107, India
Withdrawn
Lisie HospitalKochi, 682017, India
Withdrawn
Fortis HospitalMohali, 160062, India
Withdrawn
Fortis Flt. Lt. Rajan Dhall HospitalNew Delhi, 110070, India
Withdrawn
Fortis HospitalWest Mumbai, 400078, India
Withdrawn
Vijan Hospital & Research CentreNashik, 422005, India
Withdrawn
Joshi HospitalPune, 411004, India
Withdrawn
Dr. B. L. Kapur Memorial HospitalNew Delhi, 110005, India
Withdrawn
Apollo HospitalsMumbai, 400614, India
Withdrawn
HCG Hospitals, AhmedabadAhmedabad, 380006, India

Primary Outcome

  • 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.
    date_rangeTime Frame:
    Up to 18 months
  • Incidence of treatment-emergent AEs
    date_rangeTime Frame:
    Up to 18 months
  • Incidence of treatment-emergent SAEs
    date_rangeTime Frame:
    Up to 18 months
  • 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).
    date_rangeTime Frame:
    Up to 18 months

Secondary Outcome

  • 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
    date_rangeTime Frame:
    Up to 18 months
  • 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.
    date_rangeTime Frame:
    Up to 18 months
  • 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).
    date_rangeTime Frame:
    Up to 18 months
  • 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).
    date_rangeTime Frame:
    Up to 18 months
  • 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.
    date_rangeTime Frame:
    Up to 18 months

Trial design

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)
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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