NOACs Use in AF or VTE (SUNSHINE Registry)

June 6, 2022 updated by: Henan Provincial People's Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • Henan Provincial People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Profiles of patients with OACs
Time Frame: 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).
During hospitalization
Patients with AF prescribed with OAC
Time Frame: During hospitalization
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
Time Frame: During hospitalization
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of major bleeding events
Time Frame: 5 years
Major bleeding will be defined according to International Society of Thrombosis and Hemostasis (ISTH) criteria.
5 years
Number of adverse cardiac events
Time Frame: 5 years
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Henan Provincial People's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Shujuan Zhao, Henan Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 6, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2027

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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