NOACs Use in AF or VTE (SUNSHINE Registry)

Condition(s) studied

Investigational drug(s) / intervention(s)

Patients with Atrial Fibrillation (AF) or venous thromboembolism (VTE): Patients with AF or VTE; OAC treatment patterns according to patient demographics, clinical factors, risk stratification, geographic regions, local NOAC medical insurance policy and NOACs availability

Study summary

The outcomes regiStry for non-vitamin k antagonist oral anticoagUlants treatmeNt in variouS tHrombotIc dIseases for better cliNical practicE (SUNSHINE) is a multicenter, prospective, observational non-interventional inpatient/outpatient disease registry to assess the utilization of Non-vitamin k antagonist oral anticoagulants (NOACs), and associated outcomes. The SUNSHINE registry will focus on the collection and analysis of observational data in medical records from hospital information system (HIS) to evaluate the outcomes related with these NOACs when applied in extensive patient populations outside of clinical research studies. The registry will also allow for mainly combining the atrial fibrillation (AF) and venous thromboembolism (VTE) databases. In brief, the SUNSHINE registry will provide important information on the outcomes of NOACs in routine practice and gather further information on its safety and effectiveness.

Eligibility

Primary outcome measure(s)

• Profiles of patients with OACs — During hospitalization
  Patient's characteristics such as age, gender, weight, BMI, disease status; disease characteristics like co-morbidities (congestive heart failure history, hypertension, diabetes mellitus, stroke/transient ischemic attack)/thromboembolism history, vascular disease history, renal impairment, liver impairment, prior major bleeding), treatment history (previous anticoagulation strategy, duration and indication of previous anticoagulation treatment).
• Patients with AF prescribed with OAC — During hospitalization
  Difference in the proportion of patients with AF prescribed with OAC between the appropriate use and the inappropriate use group.
• Patients with VTE prescribed with OAC — During hospitalization
  Difference in the proportion of patients with VTE prescribed with OAC between the appropriate use and the inappropriate use group.

Trial sites (1)

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