Clinical and Laboratory Predictors Associated With Stroke or Systemic Embolism in Low Risk Atrial Fibrillation Patients

NCT ID: NCT03147911

Last Updated: 2018-06-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1181 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-06
• Study Completion Date: 2018-06-14

Brief Summary

The purposes of this study are to assess the prevalence of patients with a low risk of stroke or systemic embolism based on a CHA2DS2-VASc score among patients who have an AF-related thromboembolism and to identify the clinical and laboratory risk factors associated with thromboembolism in AF patients with a CHA2DS2-VA score of 0 or 1.

Detailed Description

Both European and American guidelines recommend the use of the CHA2DS2-VASc risk score which has been validated as useful risk stratification for stroke prediction in AF from several independent cohorts. The guidelines have suggested that, in non-valvular AF, OAC could be omitted for males with a CHA2DS2-VASc score of 0 and for females with a score of 1 given the true low risk of ischemic stroke in that population. The American guideline has still suggested anti-platelets therapy could be recommended in patients who only have one additional risk factor for stroke. The risk of ischemic stroke in Asian people, however, has been known to be quite different from that in Western people, especially in low risk (CHA2DS2-VASc score of 0 or 1) patients based on the CHA2DS2-VASc score. In a nationwide study from Taiwan, the annual risk of ischemic stroke was 1.21% in AF patients with a CHA2DS2-VASc score of 0 and 2.16% in AF patients with a CHA2DS2-VASc score of 1, which were much higher than that reported from Western countries. Another study which enrolled 9727 Hong Kong AF patients from a hospitalized cohort, the annual stroke rate was as high as 2.41% among 395 patients with a CHA2DS2-VASc score of 0. Furthermore, a population-based study in an East Asian cohort of 22 million people found an increased risk of stroke in younger patients (i.e., 30-55 years) with AF who are not recommended for prevention of thromboembolism by current guidelines.Thus, stroke risk among Asian patients with AF and a CHA2DS2-VASc score of 0 or 1 might be higher than that seen among Caucasians, and OAC should be recommended in such patients for effective stroke prevention.

In addition, literature review suggests that female sex as an independent risk factor of stroke is still controversial, because some studies demonstrated that the odds ratio or hazard ratio of female to male sex for thromboembolism is not significant. Indeed, the analysis of a J-RHYTHM registry revealed that female sex was not a risk for thromboembolism in the Japanese cohort. Therefore, the novel risk stratification for stroke prevention in AF patients who have CHA2DS2-VASc score of 0 or 1 in men or CHA2DS2-VASc score of 1 or 2 in female should be needed in Asian population in order to define true low risk patients in the low risk population based on the CHA2DS2-VASc scoring system.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Stroke or systemic embolism : Positive

\- 583 patients

No interventions assigned to this group

Stroke or systemic embolism : Negative

\- 598 patients

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients who experienced the stroke or systemic embolism between 2013 and 2016
• Patients who had AF before the occurrence of the stroke or systemic embolism
• Patients whose CHA2DS2-VASc score of 0 or 1 in men or CHA2DS2-VASc score of 1 or 2 in female at the time of the the stroke or systemic embolism
• Willing and able to provide informed consent
• Age greater than or equal to 18 years

• Patients who did not experience the stroke or systemic embolism between 2013 and 2016
• Patients who had AF
• Patients whose CHA2DS2-VASc score of 0 or 1 in men or CHA2DS2-VASc score of 1 or 2 in female
• Willing and able to provide informed consent
• Age greater than or equal to 18 years

• Patients with more than mild mitral valve stenosis or prosthetic mitral valve

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samjin Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Korea University Guro Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hong Euy Lim, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hong Euy Lim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

Korea University Ansan Hospital

Ansan, , South Korea

Pusan National University Hospital

Busan, , South Korea

Kosin University Gospel Hospital

Busan, , South Korea

Chungnam National University Hospital

Daejeon, , South Korea

Wonkwang University Sanbon Hospital

Gyeonggi-do, , South Korea

Gachon University Gil Medical Center

Incheon, , South Korea

Jaemin Shim

Seoul, , South Korea

Chung-ang University Hospital

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

Countries

South Korea

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Other Identifiers

KUGH17012 (CLASS-AF)

Identifier Type: -

Identifier Source: org_study_id