Clinical and Laboratory Predictors Associated With Stroke or Systemic Embolism in Low Risk Atrial Fibrillation Patients "CLASS-AF"
Active, not recruiting
Phase N/A Results N/AUpdate History
9 Mar '18 |
A location was updated in Ansan. New The overall status was removed for Korea University Ansan Hospital. A location was updated in Busan. New The overall status was removed for Pusan National University Hospital. A location was updated in Busan. New The overall status was removed for Kosin University Gospel Hospital. A location was updated in Daejeon. New The overall status was removed for Chungnam National University Hospital. A location was updated in Gyeonggi-do. New The overall status was removed for Wonkwang University Sanbon Hospital. A location was updated in Incheon. New The overall status was removed for Gachon University Gil Medical Center. A location was updated in Seoul. New The overall status was removed for Jaemin Shim. A location was updated in Seoul. New The overall status was removed for Chung-ang University Hospital. A location was updated in Seoul. New The overall status was removed for Korea University Guro Hospital. |
13 Dec '17 |
Trial acronym was updated. New CLASS-AF Trial name was updated. New Clinical and Laboratory Predictors Associated With Stroke or Systemic Embolism in Low Risk Atrial Fibrillation Patients The Summary of Purpose was updated. New
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.
Old
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 genetic factors associated with
thromboembolism in AF patients with a CHA2DS2-VA score of 0 or 1.
The description was updated. New
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.
Old
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 high risk patients in the
low risk population based on the CHA2DS2-VASc scoring system.
The eligibility criteria were updated. New
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
Old
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 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
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
|
25 Oct '17 |
A location was updated in Ansan. New The overall status was removed for Korea University Ansan Hospital. A location was updated in Seoul. New The overall status was removed for Jaemin Shim. |
8 Sep '17 |
The Summary of Purpose was updated. New
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 genetic factors associated with
thromboembolism in AF patients with a CHA2DS2-VA score of 0 or 1.
Old
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 genetic factors associated with
thromboembolism in AF patients with a CHA2DS2-VA score of 0 or 1.
The description was updated. New
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 high risk patients in the
low risk population based on the CHA2DS2-VASc scoring system.
Old
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 high risk patients in
the low risk population based on the CHA2DS2-VASc scoring system.
A location was updated in Busan. New The overall status was removed for Kosin University Gospel Hospital. A location was updated in Daejeon. New The overall status was removed for Chungnam National University Hospital. A location was updated in Gyeonggi-do. New The overall status was removed for Wonkwang University Sanbon Hospital. |
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Recruitment
- Enrollment: 1,181
- Gender: All
- Minimum Age: 18 Years
- 9 locations, 1 country
Principal Investigator
- Hong Euy Lim, MD, PhD
Professor