NOACs Use in AF or VTE (SUNSHINE Registry)
Recruiting · NCT05378308 · Observational (researchers observe without assigning treatment) · Lead sponsor: Henan Provincial People's Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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)
Where it is running
1 location listed.
- Henan Provincial People's Hospital - Zhengzhou, Henan, China