Atrial FibrillationNCT05378308
NOACs Use in AF or VTE (SUNSHINE Registry)
An observational study of Atrial Fibrillation and Venous Thromboembolism, run by Henan Provincial People's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation, Venous Thromboembolism, Oral Anticoagulant
- What is being tested?
- Patients with Atrial Fibrillation (AF) or venous thromboembolism (VTE)
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2022to 31 May 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: NOACs use in patients for various clinical scenarios (mainly with AF or VTE).
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450000
Shujuan Zhao, 0086-13837101436, 49800425@qq.com
About this study
Official title: Outcomes regiStry for Non-vitamin k Antagonist Oral anticoagUlants treatmeNt in variouS tHrombotIc dIseases for Better cliNical practicE (SUNSHINE)
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.
Read the detailed description
The SUNSHINE registry will generate the extensive integrated repository of routine clinical care data for NOACs use in patients for various clinical scenarios (mainly with AF or VTE). It will provide important information on the use of NOACs in routine clinical care and gather further information on its safety and effectiveness. The study will compare the characteristics of patients newly anticoagulated with either VKAs or NOACs, to describe the reasons for discontinuing the previous anticoagulant strategy and/or choosing the newly initiated anticoagulant treatment, and to precisely describe the prescriptions of patients newly initiated with a NOAC agent, the treatment patterns, clinical course and the clinical outcomes related with their use. The registry will be a multicenter-collaborated study led by clinical pharmacists and cooperate with health care providers (eg, cardiologists, internists, electrophysiologists, general practitioners, and so on). Target enrollment will be approximately 5,000 patients. It is expected that enrollment will finish in approximately 5 years. Patients who meet the eligibility criteria will be included. Approval from the Henan Provincial People's Hospital Institutional Review Board will be obtained before starting the survey. Since the sensitive data of each patient will be removed (e.g., by name and identification), and only presented in aggregate; therefore, informed consent is waived for this study. Confidentiality will be ensured in accordance with the Declaration of Helsinki. Data collection will include patients' electronic medical records (include demographics, clinical characteristics, medical management, laboratory measurements and imaging parameters, prescription information), the catigories of treating physicians, local NOAC medical insurance policy and NOACs availability of each institution.
- Being tested
- Patients with Atrial Fibrillation (AF) or venous thromboembolism (VTE)
- Medical subject headings
- Atrial Fibrillation, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with Atrial Fibrillation (AF) or venous thromboembolism (VTE)Other
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Profiles of patients with OACs
Patient's characteristics such as age, gender, weight, BMI, disease status; disease characteristics like co-morbidities (congestive heart failure history, hypertension, diabetes mellitus, stroke/transient ischemic attack)/thromboembolism history, vascular disease history, renal impairment, liver impairment, prior major bleeding), treatment history (previous anticoagulation strategy, duration and indication of previous anticoagulation treatment).
Measured: During hospitalization
Patients with AF prescribed with OAC
Difference in the proportion of patients with AF prescribed with OAC between the appropriate use and the inappropriate use group.
Measured: During hospitalization
Patients with VTE prescribed with OAC
Difference in the proportion of patients with VTE prescribed with OAC between the appropriate use and the inappropriate use group.
Measured: During hospitalization
Secondary outcomes (2)
Number of major bleeding events
Major bleeding will be defined according to International Society of Thrombosis and Hemostasis (ISTH) criteria.
Measured: 5 years
Number of adverse cardiac events
Cardiac events are defined as stroke or non-central nervous system (non-CNS) systemic embolism, myocardial infarction, and cardiovascular death.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start6 Jun 2022
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shujuan Zhao, Study director, Henan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378308
- Sponsor's protocol ID
- 2022-0508
- Status last verified
- May 2022
- First submitted
- 8 May 2022
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No