Registry for the use of NOACs in patients with Atrial Fibrillation or Venous Thromboembolism
Outcomes regiStry for Non-vitamin k Antagonist Oral anticoagUlants treatmeNt in variouS tHrombotIc dIseases for Better cliNical practicE (SUNSHINE)
This study is looking to see how well new blood thinners called NOACs work for people with Atrial Fibrillation or blood clots, by tracking their treatment and outcomes over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Sex | All |
| Sponsor | Henan Provincial People's Hospital Academic / other |
| Locations | 1 site (Zhengzhou, Henan) |
| Trial ID | NCT05378308 on ClinicalTrials.gov |
What this trial studies
The SUNSHINE registry is a multicenter, prospective, observational registry designed to assess the use and outcomes of non-vitamin K antagonist oral anticoagulants (NOACs) in patients with Atrial Fibrillation (AF) or Venous Thromboembolism (VTE). It will collect and analyze data from medical records to evaluate the safety and effectiveness of NOACs in routine clinical practice. The registry aims to enroll approximately 5,000 patients over a period of five years, focusing on treatment patterns, clinical courses, and outcomes associated with NOAC therapy. The study will also compare patients newly anticoagulated with NOACs versus those using vitamin K antagonists (VKAs).
Who should consider this trial
Good fit: Ideal candidates include patients clinically diagnosed with Atrial Fibrillation or Venous Thromboembolism who have been using oral anticoagulants within the last three months.
Not a fit: Patients with AF due to reversible causes, valvular AF, or those participating in other clinical trials may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the safety and effectiveness of NOACs, potentially improving treatment strategies for patients with AF and VTE.
How similar studies have performed: Other studies have shown success in utilizing observational registries to assess the outcomes of anticoagulant therapies, making this approach both relevant and valuable.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Zhengzhou, Henan
- Henan Provincial People's Hospital — Zhengzhou, Henan, China (Recruiting)
Study contacts
- Study coordinator: Shujuan Zhao
- Email: 49800425@qq.com
- Phone: 0086-13837101436
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.