Atrial FibrillationCLASS-AFNCT03147911
Clinical and Laboratory Predictors Associated With Stroke or Systemic Embolism in Low Risk Atrial Fibrillation Patients
An observational study of Atrial Fibrillation, run by Korea University Guro Hospital at 9 sites in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 1,181 participants
- Where
- 9 sitesSouth Korea
- Study dates
- 6 Apr 2017to 14 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Atrial Fibrillation(AF) patients defined as a low risk group based on a CHA2DS2-VASc score
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- Patients who do not meet all of the above listed inclusion criteria
- Patients with more than mild mitral valve stenosis or prosthetic mitral valve
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
South Korea9 sites
Korea University Ansan Hospital
Ansan, 15355
Pusan National University Hospital
Busan, 49241
Kosin University Gospel Hospital
Busan, 49267
Chungnam National University Hospital
Daejeon, 35015
Wonkwang University Sanbon Hospital
Gyeonggi-do, 15865
Gachon University Gil Medical Center
Incheon, 21565
Jaemin Shim
Seoul, 02841
Chung-ang University Hospital
Seoul, 06973
Korea University Guro Hospital
Seoul, 08308
About this study
Official title: 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
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.
Read the 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
- Keywords
- Stroke or systemic embolism, CHA2DS2-VASc score
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stroke or systemic embolism : Positive | - 583 patients | |
| Stroke or systemic embolism : Negative | - 598 patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
The 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.
Measured: Up to 1 year
Secondary outcomes (1)
The prevalence of patients with a CHA2DS2-VASc score of 0 or 1 among patients who have a AF-related thromboembolism.
The assessment of non-valvular AF patients who experienced stroke or systemic embolism between 2013 and 2016 through nationwide cohort in South Korea.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start6 Apr 2017
- Primary completion20 Feb 2018
- Study completion14 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Samjin Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Hong Euy Lim, MD, Korea University Guro Hospital
- Investigators
- Hong Euy Lim, MD, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147911
- Sponsor's protocol ID
- KUGH17012 (CLASS-AF)
- Acronym
- CLASS-AF
- Status last verified
- Jun 2018
- First submitted
- 6 May 2017
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Olesen JB, Lip GY, Hansen ML, Hansen PR, Tolstrup JS, Lindhardsen J, Selmer C, Ahlehoff O, Olsen AM, Gislason GH, Torp-Pedersen C. Validation of risk stratification schemes for predicting stroke and thromboembolism in patients with atrial fibrillation: nationwide cohort study. BMJ. 2011 Jan 31;342:d124. doi: 10.1136/bmj.d124.
PubMed 21282258Chao TF, Lin YJ, Tsao HM, Tsai CF, Lin WS, Chang SL, Lo LW, Hu YF, Tuan TC, Suenari K, Li CH, Hartono B, Chang HY, Ambrose K, Wu TJ, Chen SA. CHADS(2) and CHA(2)DS(2)-VASc scores in the prediction of clinical outcomes in patients with atrial fibrillation after catheter ablation. J Am Coll Cardiol. 2011 Nov 29;58(23):2380-5. doi: 10.1016/j.jacc.2011.08.045.
PubMed 22115643Potpara TS, Polovina MM, Licina MM, Marinkovic JM, Prostran MS, Lip GY. Reliable identification of "truly low" thromboembolic risk in patients initially diagnosed with "lone" atrial fibrillation: the Belgrade atrial fibrillation study. Circ Arrhythm Electrophysiol. 2012 Apr;5(2):319-26. doi: 10.1161/CIRCEP.111.966713. Epub 2012 Feb 8.
PubMed 22319004Olesen JB, Torp-Pedersen C, Hansen ML, Lip GY. The value of the CHA2DS2-VASc score for refining stroke risk stratification in patients with atrial fibrillation with a CHADS2 score 0-1: a nationwide cohort study. Thromb Haemost. 2012 Jun;107(6):1172-9. doi: 10.1160/TH12-03-0175. Epub 2012 Apr 3.
PubMed 22473219Chao TF, Liu CJ, Chen SJ, Wang KL, Lin YJ, Chang SL, Lo LW, Hu YF, Tuan TC, Wu TJ, Chen TJ, Tsao HM, Chen SA. Atrial fibrillation and the risk of ischemic stroke: does it still matter in patients with a CHA2DS2-VASc score of 0 or 1? Stroke. 2012 Oct;43(10):2551-5. doi: 10.1161/STROKEAHA.112.667865. Epub 2012 Aug 7.
PubMed 22871677Guo Y, Apostolakis S, Blann AD, Wang H, Zhao X, Zhang Y, Zhang D, Ma J, Wang Y, Lip GY. Validation of contemporary stroke and bleeding risk stratification scores in non-anticoagulated Chinese patients with atrial fibrillation. Int J Cardiol. 2013 Sep 30;168(2):904-9. doi: 10.1016/j.ijcard.2012.10.052. Epub 2012 Nov 17.
PubMed 23167998Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, Hindricks G, Kirchhof P; ESC Committee for Practice Guidelines (CPG). 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur Heart J. 2012 Nov;33(21):2719-47. doi: 10.1093/eurheartj/ehs253. Epub 2012 Aug 24. No abstract available.
PubMed 22922413January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2014 Dec 2;64(21):e1-76. doi: 10.1016/j.jacc.2014.03.022. Epub 2014 Mar 28. No abstract available.
PubMed 24685669Chao TF, Lip GY, Liu CJ, Tuan TC, Chen SJ, Wang KL, Lin YJ, Chang SL, Lo LW, Hu YF, Chen TJ, Chiang CE, Chen SA. Validation of a Modified CHA2DS2-VASc Score for Stroke Risk Stratification in Asian Patients With Atrial Fibrillation: A Nationwide Cohort Study. Stroke. 2016 Oct;47(10):2462-9. doi: 10.1161/STROKEAHA.116.013880. Epub 2016 Sep 13.
PubMed 27625386Siu CW, Lip GY, Lam KF, Tse HF. Risk of stroke and intracranial hemorrhage in 9727 Chinese with atrial fibrillation in Hong Kong. Heart Rhythm. 2014 Aug;11(8):1401-8. doi: 10.1016/j.hrthm.2014.04.021. Epub 2014 Apr 15.
PubMed 24747420Chang KC, Wang YC, Ko PY, Wu HP, Chen YW, Muo CH, Sung FC, Li TC, Hsu CY. Increased risk of first-ever stroke in younger patients with atrial fibrillation not recommended for antithrombotic therapy by current guidelines: a population-based study in an East Asian cohort of 22 million people. Mayo Clin Proc. 2014 Nov;89(11):1487-97. doi: 10.1016/j.mayocp.2014.08.015. Epub 2014 Nov 3.
PubMed 25444485Hughes M, Lip GY; Guideline Development Group, National Clinical Guideline for Management of Atrial Fibrillation in Primary and Secondary Care, National Institute for Health and Clinical Excellence. Stroke and thromboembolism in atrial fibrillation: a systematic review of stroke risk factors, risk stratification schema and cost effectiveness data. Thromb Haemost. 2008 Feb;99(2):295-304. doi: 10.1160/TH07-08-0508.
PubMed 18278178Pisters R, Lane DA, Marin F, Camm AJ, Lip GY. Stroke and thromboembolism in atrial fibrillation. Circ J. 2012;76(10):2289-304. doi: 10.1253/circj.cj-12-1036. Epub 2012 Sep 19.
PubMed 23001018Risk factors for stroke and efficacy of antithrombotic therapy in atrial fibrillation. Analysis of pooled data from five randomized controlled trials. Arch Intern Med. 1994 Jul 11;154(13):1449-57.
PubMed 8018000Echocardiographic predictors of stroke in patients with atrial fibrillation: a prospective study of 1066 patients from 3 clinical trials. Arch Intern Med. 1998 Jun 22;158(12):1316-20. doi: 10.1001/archinte.158.12.1316.
PubMed 9645825
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03147911
- Acronym / sponsor ID
- CLASS-AF / KUGH17012 (CLASS-AF)
- Conditions
- Atrial Fibrillation
- Keywords
- Stroke or systemic embolism, CHA2DS2-VASc score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,181 participants (actual)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Collaborators
- Samjin Pharmaceutical Co., Ltd.
- Study start
- 6 Apr 2017 (actual)
- Primary completion
- 20 Feb 2018 (actual)
- Study completion
- 14 Jun 2018 (actual)
- First posted
- 10 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke or systemic embolism : Positive | – | –- 583 patients |
| Stroke or systemic embolism : Negative | – | –- 598 patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Atrial Fibrillation(AF) patients defined as a low risk group based on a CHA2DS2-VASc score
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who do not meet all of the above listed inclusion criteria
- Patients with more than mild mitral valve stenosis or prosthetic mitral valve
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: Up to 1 year
The 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.
1 secondary outcome
The prevalence of patients with a CHA2DS2-VASc score of 0 or 1 among patients who have a AF-related thromboembolism.
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
- Background: PubMed 21282258Olesen JB, Lip GY, Hansen ML, Hansen PR, Tolstrup JS, Lindhardsen J, Selmer C, Ahlehoff O, Olsen AM, Gislason GH, Torp-Pedersen C. Validation of risk stratification schemes for predicting stroke and thromboembolism in patients with atrial fibrillation: nationwide cohort study. BMJ. 2011 Jan 31;342:d124. doi: 10.1136/bmj.d124.
- Background: PubMed 22115643Chao TF, Lin YJ, Tsao HM, Tsai CF, Lin WS, Chang SL, Lo LW, Hu YF, Tuan TC, Suenari K, Li CH, Hartono B, Chang HY, Ambrose K, Wu TJ, Chen SA. CHADS(2) and CHA(2)DS(2)-VASc scores in the prediction of clinical outcomes in patients with atrial fibrillation after catheter ablation. J Am Coll Cardiol. 2011 Nov 29;58(23):2380-5. doi: 10.1016/j.jacc.2011.08.045.
- Background: PubMed 22319004Potpara TS, Polovina MM, Licina MM, Marinkovic JM, Prostran MS, Lip GY. Reliable identification of "truly low" thromboembolic risk in patients initially diagnosed with "lone" atrial fibrillation: the Belgrade atrial fibrillation study. Circ Arrhythm Electrophysiol. 2012 Apr;5(2):319-26. doi: 10.1161/CIRCEP.111.966713. Epub 2012 Feb 8.
- Background: PubMed 22473219Olesen JB, Torp-Pedersen C, Hansen ML, Lip GY. The value of the CHA2DS2-VASc score for refining stroke risk stratification in patients with atrial fibrillation with a CHADS2 score 0-1: a nationwide cohort study. Thromb Haemost. 2012 Jun;107(6):1172-9. doi: 10.1160/TH12-03-0175. Epub 2012 Apr 3.
- Background: PubMed 22871677Chao TF, Liu CJ, Chen SJ, Wang KL, Lin YJ, Chang SL, Lo LW, Hu YF, Tuan TC, Wu TJ, Chen TJ, Tsao HM, Chen SA. Atrial fibrillation and the risk of ischemic stroke: does it still matter in patients with a CHA2DS2-VASc score of 0 or 1? Stroke. 2012 Oct;43(10):2551-5. doi: 10.1161/STROKEAHA.112.667865. Epub 2012 Aug 7.
- Background: PubMed 23167998Guo Y, Apostolakis S, Blann AD, Wang H, Zhao X, Zhang Y, Zhang D, Ma J, Wang Y, Lip GY. Validation of contemporary stroke and bleeding risk stratification scores in non-anticoagulated Chinese patients with atrial fibrillation. Int J Cardiol. 2013 Sep 30;168(2):904-9. doi: 10.1016/j.ijcard.2012.10.052. Epub 2012 Nov 17.
- Background: PubMed 22922413Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, Hindricks G, Kirchhof P; ESC Committee for Practice Guidelines (CPG). 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur Heart J. 2012 Nov;33(21):2719-47. doi: 10.1093/eurheartj/ehs253. Epub 2012 Aug 24. No abstract available.
- Background: PubMed 24685669January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2014 Dec 2;64(21):e1-76. doi: 10.1016/j.jacc.2014.03.022. Epub 2014 Mar 28. No abstract available.
- Background: PubMed 27625386Chao TF, Lip GY, Liu CJ, Tuan TC, Chen SJ, Wang KL, Lin YJ, Chang SL, Lo LW, Hu YF, Chen TJ, Chiang CE, Chen SA. Validation of a Modified CHA2DS2-VASc Score for Stroke Risk Stratification in Asian Patients With Atrial Fibrillation: A Nationwide Cohort Study. Stroke. 2016 Oct;47(10):2462-9. doi: 10.1161/STROKEAHA.116.013880. Epub 2016 Sep 13.
- Background: PubMed 24747420Siu CW, Lip GY, Lam KF, Tse HF. Risk of stroke and intracranial hemorrhage in 9727 Chinese with atrial fibrillation in Hong Kong. Heart Rhythm. 2014 Aug;11(8):1401-8. doi: 10.1016/j.hrthm.2014.04.021. Epub 2014 Apr 15.
- Background: PubMed 25444485Chang KC, Wang YC, Ko PY, Wu HP, Chen YW, Muo CH, Sung FC, Li TC, Hsu CY. Increased risk of first-ever stroke in younger patients with atrial fibrillation not recommended for antithrombotic therapy by current guidelines: a population-based study in an East Asian cohort of 22 million people. Mayo Clin Proc. 2014 Nov;89(11):1487-97. doi: 10.1016/j.mayocp.2014.08.015. Epub 2014 Nov 3.
- Background: PubMed 18278178Hughes M, Lip GY; Guideline Development Group, National Clinical Guideline for Management of Atrial Fibrillation in Primary and Secondary Care, National Institute for Health and Clinical Excellence. Stroke and thromboembolism in atrial fibrillation: a systematic review of stroke risk factors, risk stratification schema and cost effectiveness data. Thromb Haemost. 2008 Feb;99(2):295-304. doi: 10.1160/TH07-08-0508.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Euy Lim, MD, PhD principal investigator
Professor
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Korea University Guro Hospital at 9 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03147911, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2018.