Atrial FibrillationNCT02504177
Clinical Trial for Optimal Novel Oral Anticoagulant (NOAC) Schedule Immediate Before Catheter Ablation for Atrial Fibrillation
A study testing novel oral anticoagulant for 30 days and novel oral anticoagulant for 24 hour in people with Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
Trial summary
This study is to evaluated the interruption schedule of NOAC in patients who undergo atrial fibrillation ablation. The investigators will compare the bleeding complications were classified as major and minor bleeding, thromboembolic, vascular complications, Re-admission and increased in the length of hospital stay… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- novel oral anticoagulant for 30 days and novel oral anticoagulant for 24 hour
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 433 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2015to Jun 2019
- Phase
- Interventional
- 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
Who may be able to join
- Patients who consent with study
- Patients with Atrial fibrillation (20-80 years old)
- patients who undergoing catheter ablation of atrial fibrillation due to symptomatic, drug refractory atrial fibrillation
- Patients possible to NOAC
Who cannot join
- Patients who do not agree with study inclusion
- eGRF < 30ml/min
- Impossible to NOAC
- Structural cardiac disease
- Major hemorrhagic complication
- CHA2DS2-VASc score > 5
- Patients who have experienced Ischemic cerebellar infarction more than 2times
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Cardiovascular Hospital, Yonsei University Health System
Seoul, 120-752
Hui-Nam Pak, M.D., Ph.D., 82-2-2228-8459, hnpak@yuhs.ac
About this study
This study is to evaluated the interruption schedule of NOAC in patients who undergo atrial fibrillation ablation. The investigators will compare the bleeding complications were classified as major and minor bleeding, thromboembolic, vascular complications, Re-admission and increased in the length of hospital stay during the 30-day post-radiofrequency catheter ablation(RFCA) period among patients who interrupt NOAc 24hours before ablation and patients who stop NOAC in the morning of the procedure.
- Conditions
- Atrial Fibrillation
- Being tested
- novel oral anticoagulant for 30 days, novel oral anticoagulant for 24 hour
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
novel oral anticoagulant for 30 daysDrug
novel oral anticoagulant includes 'dabigatran,Pradaxa®', 'rivaroxaban,Xarelto®', and 'apixaban, Eliquis®'.
novel oral anticoagulant for 24 hourDrug
novel oral anticoagulant includes 'dabigatran,Pradaxa®', 'rivaroxaban,Xarelto®', and 'apixaban, Eliquis®'.
| Study group | Role | What they receive |
|---|---|---|
| The group of keep medication NOAC | Experimental | The randomization after scheduling of Ablation at clinic The explanation to stop taking medicine of NOAC 24 hours before the ablation Receives: Drug: novel oral anticoagulant for 30 days |
| The group of stop medication NOAC 1 day | Active comparator | The randomization after scheduling of ablation at clinic. The explanation to stop taking medicine of NOAC day of ablation Receives: Drug: novel oral anticoagulant for 24 hour |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of major bleeding complications
Bleeding complication is assessed by physical examination or laboratory measurement
Measured: during 30 days post-AF ablation.
Secondary outcomes (5)
incidence of thromboembolism
thromboembolism is diagnosed by both clinical situations and image studies combined.
Measured: during 30 days post-AF ablation.
incidence of minor bleeding
Measured: during 30 days post-AF ablation.
Re-admission rate related procedure
Measured: during 30 days post-AF ablation.
length of hospital stay
Measured: during 30 days post-AF ablation.
incidence of vascular complications
vascular complication is diagnosed by both clinical situations and image studies combined.
Measured: during 30 days post-AF ablation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 433 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
- NCT02504177
- Sponsor's protocol ID
- 4-2015-0387
- Status last verified
- Feb 2019
- First submitted
- 14 Jul 2015
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for Optimal Novel Oral Anticoagulant (NOAC) Schedule Immediate Before Catheter Ablation for Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02504177
- Acronym / sponsor ID
- 4-2015-0387
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 433 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 21 Jul 2015 (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 to evaluated the interruption schedule of NOAC in patients who undergo atrial fibrillation ablation. The investigators will compare the bleeding complications were classified as major and minor bleeding, thromboembolic, vascular complications, Re-admission and increased in the length of hospital stay during the 30-day post-radiofrequency catheter ablation(RFCA) period among patients who interrupt NOAc 24hours before ablation and patients who stop NOAC in the morning of the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The group of keep medication NOAC | Experimental | Drug: novel oral anticoagulant for 30 daysThe randomization after scheduling of Ablation at clinic The explanation to stop taking medicine of NOAC 24 hours before the ablation |
| The group of stop medication NOAC 1 day | Active comparator | Drug: novel oral anticoagulant for 24 hourThe randomization after scheduling of ablation at clinic. The explanation to stop taking medicine of NOAC day of ablation |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who consent with study
- Patients with Atrial fibrillation (20-80 years old)
- patients who undergoing catheter ablation of atrial fibrillation due to symptomatic, drug refractory atrial fibrillation
- Patients possible to NOAC
Key exclusion criteria (7 listed)
- Patients who do not agree with study inclusion
- eGRF < 30ml/min
- Impossible to NOAC
- Structural cardiac disease
- Major hemorrhagic complication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| novel oral anticoagulant for 30 daysnovel oral anticoagulant includes 'dabigatran,Pradaxa®', 'rivaroxaban,Xarelto®', and 'apixaban, Eliquis®'. | Drug | The group of keep medication NOAC |
| novel oral anticoagulant for 24 hournovel oral anticoagulant includes 'dabigatran,Pradaxa®', 'rivaroxaban,Xarelto®', and 'apixaban, Eliquis®'. | Drug | The group of stop medication NOAC 1 day |
Primary outcome
incidence of major bleeding complications
Time frame: during 30 days post-AF ablation.
Bleeding complication is assessed by physical examination or laboratory measurement
5 secondary outcomes
incidence of thromboembolism
Time frame: during 30 days post-AF ablation.
incidence of minor bleeding
Time frame: during 30 days post-AF ablation.
Re-admission rate related procedure
Time frame: during 30 days post-AF ablation.
length of hospital stay
Time frame: during 30 days post-AF ablation.
incidence of vascular complications
Time frame: during 30 days post-AF ablation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
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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.
Severance Cardiovascular Hospital, Yonsei University Health System
Seoul, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing novel oral anticoagulant for 30 days and novel oral anticoagulant for 24 hour in people with 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 4 inclusion and 7 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 15 Feb 2019. 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?
incidence of major bleeding complications (time frame: during 30 days post-AF ablation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2019.