跳至主要内容
临床试验/NCT05378308
NCT05378308招募中不适用

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

Henan Provincial People's Hospital1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2022年6月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
5,000
试验地点
1
主要终点
Profiles of patients with OACs

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Profiles of patients with OACs

时间窗: During hospitalization

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).

Patients with VTE prescribed with OAC

时间窗: During hospitalization

Difference in the proportion of patients with VTE prescribed with OAC between the appropriate use and the inappropriate use group.

Patients with AF prescribed with OAC

时间窗: During hospitalization

Difference in the proportion of patients with AF prescribed with OAC between the appropriate use and the inappropriate use group.

次要结局

  • Number of adverse cardiac events(5 years)
  • Number of major bleeding events(5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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