Atrial FibrillationNCT02786095
Comparison Study of Drugs for Symptom Control and Complication Prevention of Atrial Fibrillation (AF) (Code-AF Trial)
An observational study of Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
Trial summary
This study is prospective Cohort study which was performed in multicenter (General Hospital) in Korea. Inclusion criteria is all patients with atrial fibrillation who visit hospital. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 20,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2016to Oct 2024
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with atrial fibrillation
Who may be able to join
- patients with atrial fibrillation
- patients with age more than 19
- patients who agree with study inclusion
Who cannot join
- patients who do not agree with study inclusion
- patients with age less than 19
- Pregnancy, Breastfeeding
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine
Seoul, 120-752
Boyoung Joung, MD, 82-2-2228-8460, cby6908@yuhs.ac
About this study
This study is prospective Cohort study which was performed in multicenter (General Hospital) in Korea. Inclusion criteria is all patients with atrial fibrillation who visit hospital. The purpose is to analyze complication, composite outcome (all cause mortality, hospitalization, the incidence of stroke, heart failure and cardiovascular event (MACE)) according to the 1) the use of anti-arrhythmic drugs (AADs), 2) use of medication for rate control (beta blocker, calcium channel blocker and digoxin) and 3) use of anticoagulation agents (warfarin, coumadin, an NOAC)
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, anti arrhythmic drug, NOAC, warfarin, coumadin
- Medical subject headings
- Atrial Fibrillation
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 |
|---|---|---|
| Code-AF registry | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: 3 years
number of hospitalization by heart failure
Measured: 3 years
number of recurrent stroke
Measured: 3 years
number of cardiovascular events
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2016 (estimated)
- Study start1 May 2016
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02786095
- Sponsor's protocol ID
- 4-2016-0105
- Status last verified
- Jun 2018
- First submitted
- 25 May 2016
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Park H, Yu HT, Kim TH, Park J, Park JK, Kang KW, Shim J, Kim JB, Kim J, Choi EK, Park HW, Lee YS, Joung B. Oral Anticoagulation Therapy in Atrial Fibrillation Patients with Advanced Chronic Kidney Disease: CODE-AF Registry. Yonsei Med J. 2023 Jan;64(1):18-24. doi: 10.3349/ymj.2022.0455.
PubMed 36579375Kim JY, Park HS, Park HW, Choi EK, Park JK, Kim JB, Kang KW, Shim J, Joung B, Park KM. Clinical Outcomes of Rhythm Control Strategies for Asymptomatic Atrial Fibrillation According to the Quality-of-Life Score: The CODE-AF (Comparison Study of Drugs for Symptom Control and Complication Prevention of Atrial Fibrillation) Registry. J Am Heart Assoc. 2022 Sep 20;11(18):e025956. doi: 10.1161/JAHA.122.025956. Epub 2022 Sep 8.
PubMed 36073646Kim M, Kim J, Kim JB, Park J, Park JK, Kang KW, Shim J, Choi EK, Lee YS, Park HW, Joung B. Association of Gender With Clinical Outcomes in a Contemporary Cohort of Patients With Atrial Fibrillation Receiving Oral Anticoagulants. Korean Circ J. 2022 Aug;52(8):593-603. doi: 10.4070/kcj.2021.0399. Epub 2022 Apr 26.
PubMed 35656931Lee KB, Kim TH, Park J, Park JK, Kang KW, Kim J, Park HW, Choi EK, Kim JB, Lee YS, Shim J, Joung B. Stroke and Systemic Thromboembolism according to CHA2DS2-VASc Score in Contemporary Korean Patients with Atrial Fibrillation. Yonsei Med J. 2022 Apr;63(4):317-324. doi: 10.3349/ymj.2022.63.4.317.
PubMed 35352882
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Study of Drugs for Symptom Control and Complication Prevention of Atrial Fibrillation (AF) (Code-AF Trial)
- ClinicalTrials.gov ID
- NCT02786095
- Acronym / sponsor ID
- 4-2016-0105
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, anti arrhythmic drug, NOAC, warfarin, coumadin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 30 May 2016 (estimated)
- 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.
This study is prospective Cohort study which was performed in multicenter (General Hospital) in Korea. Inclusion criteria is all patients with atrial fibrillation who visit hospital. The purpose is to analyze complication, composite outcome (all cause mortality, hospitalization, the incidence of stroke, heart failure and cardiovascular event (MACE)) according to the 1) the use of anti-arrhythmic drugs (AADs), 2) use of medication for rate control (beta blocker, calcium channel blocker and digoxin) and 3) use of anticoagulation agents (warfarin, coumadin, an NOAC)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Code-AF registry | – | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with atrial fibrillation
Key inclusion criteria (3 listed)
- patients with atrial fibrillation
- patients with age more than 19
- patients who agree with study inclusion
Key exclusion criteria (3 listed)
- patients who do not agree with study inclusion
- patients with age less than 19
- Pregnancy, Breastfeeding
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
all cause mortality
Time frame: 3 years
number of hospitalization by heart failure
Time frame: 3 years
number of recurrent stroke
Time frame: 3 years
number of cardiovascular events
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
- Derived from this study: PubMed 36579375Park H, Yu HT, Kim TH, Park J, Park JK, Kang KW, Shim J, Kim JB, Kim J, Choi EK, Park HW, Lee YS, Joung B. Oral Anticoagulation Therapy in Atrial Fibrillation Patients with Advanced Chronic Kidney Disease: CODE-AF Registry. Yonsei Med J. 2023 Jan;64(1):18-24. doi: 10.3349/ymj.2022.0455.
- Derived from this study: PubMed 36073646Kim JY, Park HS, Park HW, Choi EK, Park JK, Kim JB, Kang KW, Shim J, Joung B, Park KM. Clinical Outcomes of Rhythm Control Strategies for Asymptomatic Atrial Fibrillation According to the Quality-of-Life Score: The CODE-AF (Comparison Study of Drugs for Symptom Control and Complication Prevention of Atrial Fibrillation) Registry. J Am Heart Assoc. 2022 Sep 20;11(18):e025956. doi: 10.1161/JAHA.122.025956. Epub 2022 Sep 8.
- Derived from this study: PubMed 35656931Kim M, Kim J, Kim JB, Park J, Park JK, Kang KW, Shim J, Choi EK, Lee YS, Park HW, Joung B. Association of Gender With Clinical Outcomes in a Contemporary Cohort of Patients With Atrial Fibrillation Receiving Oral Anticoagulants. Korean Circ J. 2022 Aug;52(8):593-603. doi: 10.4070/kcj.2021.0399. Epub 2022 Apr 26.
- Derived from this study: PubMed 35352882Lee KB, Kim TH, Park J, Park JK, Kang KW, Kim J, Park HW, Choi EK, Kim JB, Lee YS, Shim J, Joung B. Stroke and Systemic Thromboembolism according to CHA2DS2-VASc Score in Contemporary Korean Patients with Atrial Fibrillation. Yonsei Med J. 2022 Apr;63(4):317-324. doi: 10.3349/ymj.2022.63.4.317.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
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.
Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine
Seoul, South Korea
1 site 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 Yonsei University at 1 site 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 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 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: 3 years). The study lists 4 primary outcomes in all. 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 NCT02786095, which also lists 4 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 20 Jun 2018.