Patients with Atrial Fibrillation (AF) or venous thromboembolism (VTE)
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
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Patients with clinically diagnosed with AF (eg, by electrocardiogram, Holter monitoring, implanted device, etc) or VTE (initial or recurrent acute VTE)
* Patients who use OACs therapy (including NOAC or VKA) within the preceding 3 months
* Patients can be enrolled from both inpatient or outpatient settings
Exclusion Criteria:
* AF resulting from reversible cause factors (e.g., thyroid disease, postoperative AF)
* Patients with a diagnosis of valvular AF (valvular AF mainly refers to patients with AF that have either rheumatic valvular disease \[predominantly mitral stenosis\] or mechanical heart valves)
* Patients participating in an ongoing clinical trial in AF or VTE
* Have Multiple anticoagulation indications apart from AF or VTE
* Patients with incomplete information (illogical data, missing or insufficient data)
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)
Facility
City
Region
Status
Henan Provincial People's Hospital
Zhengzhou
Henan
Recruiting
More Henan Provincial People's Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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