NCT05378308 NOACs Use in AF or VTE (SUNSHINE Registry)
| NCT ID | NCT05378308 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Henan Provincial People's Hospital |
| Condition | Atrial Fibrillation |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2022-06-06 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,000 participants in total. It began in 2022-06-06 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Contact & Investigator
Shujuan Zhao
STUDY DIRECTOR
Henan Provincial People's Hospital
Frequently Asked Questions
Who can join the NCT05378308 clinical trial?
This trial is open to participants of all sexes, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05378308 currently recruiting?
Yes, NCT05378308 is actively recruiting participants. Contact the research team at 49800425@qq.com for enrollment information.
Where is the NCT05378308 trial being conducted?
This trial is being conducted at Zhengzhou, China.
Who is sponsoring the NCT05378308 clinical trial?
NCT05378308 is sponsored by Henan Provincial People's Hospital. The principal investigator is Shujuan Zhao at Henan Provincial People's Hospital. The trial plans to enroll 5,000 participants.
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