Quality of Anticoagulation With Warfarin in Patient With Atrial Fibrillation for Secondary Stroke Prevention in Korea

An observational study of Atrial Fibrillation and Stroke, run by Inje University at 18 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The current study aims to assess the quality of anticoagulation with warfarin in real world practice of secondary stroke prevention in Korean patients with Atrial fibrillation (AF) and to explore predictors for poor International Normalized Range (INR) control. Read more about this study

Who is it for?: Any age
Conditions the study is for: Atrial Fibrillation, Stroke
How many people: 1,814 participants
Where: 18 sitesSouth Korea
Study dates: Jun 2015to Oct 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Consecutive patients who admitted to 16 participating centers due to AF-related ischemic stroke between Jan 1, 2011 and Dec 31, 2012 and started warfarin therapy for secondary stroke prevention will be enrolled in this study. The number of patients is expected to be 2,217 for the warfarin-initiated cohort and 1,057 for the long-term warfarin-treated cohort.

Who may be able to join

Admission due to AF-related ischemic stroke
Initiation of warfarin therapy and treatment at least for more than 7 days of warfarin adjustment period
For TTR calculation, available consecutive INR values ≥3 after the 7 days of warfarin adjustment
Inclusion criteria for the long-term warfarin-treated cohort
Admission due to AF-related ischemic stroke
Long-term warfarin therapy at least for more than 90 days after the 7 days of warfarin adjustment period
For TTR calculation, available consecutive INR values ≥3 after the 7 days of warfarin adjustment
TTR evaluable days ≥ 90 days

Who cannot join

AF with mechanical valve
Enrollment in anticoagulation randomized clinical trial
Enrollment in studies affecting the target INR range.

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

South Korea18 sites

Hallym University College of Medicine
Anyang
Dong-A University College of Medicine
Busan
Yeungnam University School of Medicine
Daegu
Dongguk University Ilsan Hospital
Goyang
Chonnam National University Medical School
Gwangju
Ilsan Paik Hospital Inje University
Ilsan
Inha University Hospital
Incheon
Jeju National University Hospital, Jeju National University College of Medicine
Jeju City
Seoul National University Bundang Hospital
Seongnam
Eulji General Hospital, Eulji University School of Medicine
Seoul
Korea University College of Medicine
Seoul
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul
Seoul Medical Center
Seoul
Seoul National University College of Medicine
Seoul
Soonchunhyang University College of Medicine
Seoul
Soonchunhyang University
Seoul
University of Ulsan College of Medicine
Seoul
Yonsei University College of Medicine
Seoul

Other trials in South Korea

About this study

Read the detailed description

To assess the quality of anticoagulation with warfarin in real world practice of Korea for secondary stroke prevention in patients with AF-related Cardioembolic (CE) stroke 1) who initiated warfarin therapy and treatment at least for more than 7 days of warfarin adjustment period (warfarin-initiated cohort), and 2) who initiated and maintained warfarin therapy at least for more than 90 days after the 7 days of warfarin adjustment period (long-term warfarin-treated cohort).
To explore predictors for poor INR control.

Conditions: Atrial Fibrillation, Stroke
Keywords: Wafarin, Cardioembolic (CE) stroke, ischemic stroke
Medical subject headings: Atrial Fibrillation, Stroke, Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02810509
Study group	Role	What they receive
Short-term Warfarin-treated cohort		1. admission due to AF-related ischemic stroke (known AF or newly detected AF) 2. for TTR calculation, the number of consecutive INR measurements ≥3 after the 7 days of warfarin adjustment 3. TTR evaluable days < 90 days
Long-term Warfarin-treated cohort		1. admission due to AF-related ischemic stroke (known AF or newly detected AF) 2. long-term warfarin therapy at least for more than 90 days after the 7 days of warfarin adjustment period 3. for TTR calculation, the number of consecutive INR measurements ≥3 after the 7 days of warfarin adjustment 4. TTR evaluable days ≥ 90 days

What is being measured

The primary outcome is the main question the study is designed to answer.

Time in TTR, the Percentage of Time in the Therapeutic Range of INR Between 2.0-3.0.
The primary outcome is TTR as measured by the percentage of time in the therapeutic range of INR between 2.0-3.0, using the Rosendaal linear interpolation method.
Measured: We will analyze INR data of patients who had AF-related ischemic stroke and were treated with warfarin therapy at least for more than 7 days of warfarin adjustment period. (The INR follow up duration: 1 ~ maximum 3 years)

Secondary outcomes (1)

Percentage of INR Values in the Therapeutic Range of 2.0-3.0: Numbers of INR Values Within the Therapeutic Range by the Total Numbers of INR Measured.
The secondary outcome is the percentage of INR values in the therapeutic range of 2.0-3.0: numbers of INR values within the therapeutic range divided by the total numbers of INR measured.
Measured: We will analyze INR data of patients who had AF-related ischemic stroke and were treated with warfarin therapy at least for more than 7 days of warfarin adjustment period. (The INR follow up duration: 1 ~ maximum 3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2015Oct 2016

First posted23 Jun 2016 (estimated)
Study startJun 2015
Primary completionOct 2016
Study completionOct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 1,814 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02810509
Sponsor's protocol ID: Warfarin TTR-01
Status last verified: Aug 2018
First submitted: 23 Dec 2015
Last updated: 13 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Quality of Anticoagulation With Warfarin in Patient With Atrial Fibrillation for Secondary Stroke Prevention in Korea
ClinicalTrials.gov ID: NCT02810509
Acronym / sponsor ID: Warfarin TTR-01
Conditions: Atrial Fibrillation, Stroke
Keywords: Wafarin, Cardioembolic (CE) stroke, ischemic stroke
Study type: Observational
Recruitment status: Completed
Enrolment: 1,814 participants (actual)
Lead sponsor: Inje UniversityUniversity, hospital or other
Study start: Jun 2015
Primary completion: Oct 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 23 Jun 2016 (estimated)
Results: Posted 13 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

To assess the quality of anticoagulation with warfarin in real world practice of Korea for secondary stroke prevention in patients with AF-related Cardioembolic (CE) stroke 1) who initiated warfarin therapy and treatment at least for more than 7 days of warfarin adjustment period (warfarin-initiated cohort), and 2) who initiated and maintained warfarin therapy at least for more than 90 days after the 7 days of warfarin adjustment period (long-term warfarin-treated cohort).
To explore predictors for poor INR control.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Short-term Warfarin-treated cohort	–	–1. admission due to AF-related ischemic stroke (known AF or newly detected AF) 2. for TTR calculation, the number of consecutive INR measurements ≥3 after the 7 days of warfarin adjustment 3. TTR evaluable days < 90 days
Long-term Warfarin-treated cohort	–	–1. admission due to AF-related ischemic stroke (known AF or newly detected AF) 2. long-term warfarin therapy at least for more than 90 days after the 7 days of warfarin adjustment period 3. for TTR calculation, the number of consecutive INR measurements ≥3 after the 7 days of warfarin adjustment 4. TTR evaluable days ≥ 90 days

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Consecutive patients who admitted to 16 participating centers due to AF-related ischemic stroke between Jan 1, 2011 and Dec 31, 2012 and started warfarin therapy for secondary stroke prevention will be enrolled in this study. The number of patients is expected to be 2,217 for the warfarin-initiated cohort and 1,057 for the long-term warfarin-treated cohort.

Key inclusion criteria (8 listed)

Admission due to AF-related ischemic stroke
Initiation of warfarin therapy and treatment at least for more than 7 days of warfarin adjustment period
For TTR calculation, available consecutive INR values ≥3 after the 7 days of warfarin adjustment
Inclusion criteria for the long-term warfarin-treated cohort
Admission due to AF-related ischemic stroke

Key exclusion criteria (3 listed)

AF with mechanical valve
Enrollment in anticoagulation randomized clinical trial
Enrollment in studies affecting the target INR range.

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

Time in TTR, the Percentage of Time in the Therapeutic Range of INR Between 2.0-3.0.
Time frame: We will analyze INR data of patients who had AF-related ischemic stroke and were treated with warfarin therapy at least for more than 7 days of warfarin adjustment period. (The INR follow up duration: 1 ~ maximum 3 years)
The primary outcome is TTR as measured by the percentage of time in the therapeutic range of INR between 2.0-3.0, using the Rosendaal linear interpolation method.

1 secondary outcome

Percentage of INR Values in the Therapeutic Range of 2.0-3.0: Numbers of INR Values Within the Therapeutic Range by the Total Numbers of INR Measured.
Time frame: We will analyze INR data of patients who had AF-related ischemic stroke and were treated with warfarin therapy at least for more than 7 days of warfarin adjustment period. (The INR follow up duration: 1 ~ maximum 3 years)

Results and safety

Results posted to the registry on 13 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Short Term Wafarin-treated Cohort	584	584
Long Term Warfarin-treated Cohort	1,230	1,230

Primary outcome: Time in TTR, the Percentage of Time in the Therapeutic Range of INR Between 2.0-3.0.

Time frame: We will analyze INR data of patients who had AF-related ischemic stroke and were treated with warfarin therapy at least for more than 7 days of warfarin adjustment period. (The INR follow up duration: 1 ~ maximum 3 years). Mean (Standard Deviation). Unit: percentage of time in therapeutic range

Measure	Short-term Cohort n = 584	Long-term Cohort n = 1230
Value	43.4 (26.3)	49.1 (20.8)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: This is an investigator-initiated study of a retrospective observation study therefore, adverse events and serious adverse events are not collected through this study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Warfarin-initiated Cohort	0 of 0	0 of 0	Not reported
Long Term Warfarin-treated Cohort	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Atrial Fibrillation

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.

Keun-Sik Hong, MD, Phd principal investigator

Department of Neurology, Ilsan Paik Hospital Inje University

18 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 and Stroke, run by Inje University at 18 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 8 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: finished, as of the sponsor's last update on 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 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?

Yes. Results are posted in the registry (first posted 13 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Time in TTR, the Percentage of Time in the Therapeutic Range of INR Between 2.0-3.0. (time frame: We will analyze INR data of patients who had AF-related ischemic stroke and were treated with warfarin therapy at least for more than 7 days of warfarin adjustment period. (The INR follow up duration: 1 ~ maximum 3 years)). 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 NCT02810509.

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 13 Sep 2019.