Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05378308 |
Other study ID # |
2022-0508 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.