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

Clinical and Laboratory Predictors Associated With Stroke or Systemic Embolism in Atrial Fibrillation Patients Defined as Population With a Low Risk of Stroke Based on a CHA2DS2-VASc Score

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03147911
Acronym
CLASS-AF
Enrollment
1181
Registered
2017-05-10
Start date
2017-04-06
Completion date
2018-06-14
Last updated
2018-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Stroke or systemic embolism, CHA2DS2-VASc score

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.

Interventions

None listed

Sponsors

Samjin Pharmaceutical Co., Ltd.
CollaboratorINDUSTRY
Korea University Guro Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

(Experimental Group): * 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 Inclusion Criteria (Control Group): * 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

Exclusion criteria

(Both experiment and control groups) * Patients who do not meet all of the above listed inclusion criteria * Patients with more than mild mitral valve stenosis or prosthetic mitral valve

Design outcomes

Primary

MeasureTime frameDescription
The novel risk stratification regarding stroke or systemic embolism in order to discriminate true low-risk patients from low-risk patients based on a CHA2DS2-VASc score.Up to 1 yearThe identification of clinical and laboratory factors that can predict stroke or systemic embolism in non-valvular AF patients with a CHA2DS2-VA score of 0 or 1.

Secondary

MeasureTime frameDescription
The prevalence of patients with a CHA2DS2-VASc score of 0 or 1 among patients who have a AF-related thromboembolism.Up to 1 yearThe assessment of non-valvular AF patients who experienced stroke or systemic embolism between 2013 and 2016 through nationwide cohort in South Korea.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026