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)

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Venous Thromboembolism; Oral Anticoagulant
• Intervention / Treatment: Other: Patients with Atrial Fibrillation (AF) or venous thromboembolism (VTE)

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.

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

• Study Contact: Name: Shujuan Zhao; Phone Number: 0086-13837101436; Email: 49800425@qq.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • Henan Provincial People's Hospital
      • Contact: Shujuan Zhao; Phone Number: 0086-13837101436; Email: 49800425@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

NOACs use in patients for various clinical scenarios (mainly with AF or VTE).

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of major bleeding events	Major bleeding will be defined according to International Society of Thrombosis and Hemostasis (ISTH) criteria.	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.	5 years

Collaborators and Investigators

• Sponsor: Henan Provincial People's Hospital
• Investigators: Study Director: Shujuan Zhao, Henan Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2022
• Primary Completion (Anticipated): May 31, 2027
• Study Completion (Anticipated): May 31, 2027

Study Registration Dates

• First Submitted: May 8, 2022
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 6, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Arrhythmias, Cardiac; Atrial Fibrillation; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: 2022-0508

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No