RecruitingNCT05378308

NOACs Use in AF or VTE (SUNSHINE Registry)

Outcomes regiStry for Non-vitamin k Antagonist Oral anticoagUlants treatmeNt in variouS tHrombotIc dIseases for Better cliNical practicE (SUNSHINE)

Sponsor

Henan Provincial People's Hospital

Enrollment

5,000 participants

Start Date

Jun 6, 2022

Study Type

OBSERVATIONAL

Conditions

Atrial Fibrillation Venous Thromboembolism Oral Anticoagulant

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

Inclusion Criteria3

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 Criteria5

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)

Interventions

OTHERPatients 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