NOACs Use in AF or VTE (SUNSHINE Registry)

Atrial Fibrillation Clinical Trial

Official title:

Outcomes regiStry for Non-vitamin k Antagonist Oral anticoagUlants treatmeNt in variouS tHrombotIc dIseases for Better cliNical practicE (SUNSHINE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05378308
• Other study ID #: 2022-0508
• Status: Recruiting
• Start date: June 6, 2022
• Est. completion date: May 31, 2027

Study information

• Verified date: May 2022
• Source: Henan Provincial People's Hospital
• Contact: Shujuan Zhao
• Phone: 0086-13837101436
• Email: 49800425[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: May 31, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Oral Anticoagulant
• Thromboembolism
• Venous Thromboembolism

Intervention

Other:
• Patients with Atrial Fibrillation (AF) or venous thromboembolism (VTE)
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

Locations

Country	Name	City	State
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	During hospitalization
Primary	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.	During hospitalization
Primary	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.	During hospitalization
Secondary	Number of major bleeding events	Major bleeding will be defined according to International Society of Thrombosis and Hemostasis (ISTH) criteria.	5 years
Secondary	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.	5 years