NCT05378308Recruiting
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)
Source: ClinicalTrials.gov · Last updated 9 Jun 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 5000 (estimated)
- First submitted
- 8 May 2022
- Start date
- 6 Jun 2022
- Primary completion date
- 31 May 2027
- Lead sponsor
- Henan Provincial People's Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT05378308
What you commit to
- Study type: Observational
- Planned participants: 5000
- From 6 Jun 2022 to the primary completion date, 31 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Other
- 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)
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Henan Provincial People's Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.