NOACs Use in AF or VTE (SUNSHINE Registry)

NCT05378308 | Recruiting

• 1 other identifier: 2022-0508
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Venous Thromboembolism; Oral Anticoagulant

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Number of major bleeding events

  5 years

• Number of adverse cardiac events

  5 years

Interventions

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

Study Sites (1)

Henan Provincial People's Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Venous Thromboembolism

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Thromboembolism; Embolism and Thrombosis; Vascular Diseases

Study Officials

• Shujuan Zhao

  Henan Provincial People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Shujuan Zhao

CONTACT

0086-13837101436; 49800425@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2022
• First Posted: May 18, 2022
• Study Start: June 6, 2022
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: June 9, 2022

Record last verified: 2022-05

Locations

CN (1)