NOACs Use in AF or VTE (SUNSHINE Registry)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorHenan Provincial People's Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
NOACs use in patients for various clinical scenarios (mainly with AF or VTE).
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Patients with Atrial Fibrillation (AF) or venous thromboembolism (VTE)
Other interventionPatients 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
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Profiles of patients with OACs
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).
Time frame
During hospitalization2
Patients with AF prescribed with OAC
Difference in the proportion of patients with AF prescribed with OAC between the appropriate use and the inappropriate use group.
Time frame
During hospitalization3
Patients with VTE prescribed with OAC
Difference in the proportion of patients with VTE prescribed with OAC between the appropriate use and the inappropriate use group.
Time frame
During hospitalizationSecondary outcomes
1
Number of major bleeding events
Major bleeding will be defined according to International Society of Thrombosis and Hemostasis (ISTH) criteria.
Time frame
5 years2
Number of adverse cardiac events
Cardiac events are defined as stroke or non-central nervous system (non-CNS) systemic embolism, myocardial infarction, and cardiovascular death.
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov