Atrial FibrillationPhase 3NCT02544932
Pleotropic Effect of New Oral Anticoagulants
A Phase 3 study testing dabigatran, ribaroxaban and Warfarin in people with Atrial Fibrillation, run by Kyunghee University Medical Center at 1 site in South Korea.
Trial summary
Atrial fibrillation (AF) has been known to have several pathophysiologic mechanisms including endothelial dysfunction of heart and vessel. This study was designed to determine the efficacy of NOAC therapy in the prevention of endothelial dysfunction and progression of atherosclerosis of AF subjects. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- dabigatran, ribaroxaban and Warfarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2015to Sep 2017
- Phase
- Phase 3
- 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 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- CHA2DS2-VASc score above 2
Who cannot join
- severe peripheral arterial disease (greater than a Fontaine IIb category)
- grade 4 or higher cerebral infarction on the Modified Rankin Scale
- proven coronary artery disease by coronary angiogram
- severe hepatic or renal dysfunction
- uncontrolled congestive heart failure
- uncontrolled hypertension or diabetes mellitus
Show all 9Show fewer
- hematologic disorders
- allergy or hypersensitivity to the investigational drugs
- pregnant or lactating women or women wishing to become pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Study for Evaluating Vascular Protective Effects of New Oral Anticoagulants in High Risk Patients With Atrial Fibrillation
Atrial fibrillation (AF) has been known to have several pathophysiologic mechanisms including endothelial dysfunction of heart and vessel. This study was designed to determine the efficacy of NOAC therapy in the prevention of endothelial dysfunction and progression of atherosclerosis of AF subjects.
Read the detailed description
The properties of oral, direct inhibitors of factor Xa (e.g. rivaroxaban) and thrombin (e.g. dabigatran) have been examined the haemostasis and thromboembolism management. Preclinical studies have provided evidences for the effects of direct factor Xa or thrombin inhibition beyond anticoagulation, including anti-inflammatory and protective activities in atherosclerotic plaque development . Therefore, this study evaluates the protective effects of NAOC with the reactive hyperemia peripheral arterial tonometry (RH-PAT) measurements reflecting endothelial function by Endo-PAT2000 and intima-media thickness (IMT) of the carotid artery, which is used as a surrogate endpoint of atherosclerosis.
- Conditions
- Atrial Fibrillation
- Being tested
- dabigatran, ribaroxaban, Warfarin
- Keywords
- anticoagulant, atherosclerosis, endothelium
- Medical subject headings
- Atrial Fibrillation, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dabigatranDrug
Also called pradaxa
After randomization, patients of this group was will be treated to dabigatran 110mg or 150mg twice a day for 24months
ribaroxabanDrug
Also called xarelto
After randomization, patients of this group was will be treated to ribaroxaban 20mg once a day for 24months.
WarfarinDrug
After randomization, patients of this group was will be treated to warfarin and controlled by INR 2-3 for 24months.
| Study group | Role | What they receive |
|---|---|---|
| dabigatran 110mg or 150mg | Experimental | After once enrolled, subjects will be randomized to dabigatran group. (110mg or 150mg twice a day) Receives: Drug: dabigatran |
| ribaroxaban 20mg | Experimental | After once enrolled, subjects will be randomized to ribaroxaban group. (20mg once daily) Receives: Drug: ribaroxaban |
| warfarin | Active comparator | After once enrolled, subjects will be randomized to warfarin group. (controlled by INR 2-3) Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes in reactive hyperemia index (RHI)
Measured: 12months
Secondary outcomes (3)
right and left maximum IMT of the common carotid artery (CCA)
Measured: 24months
right and left mean IMT of the common carotid artery (CCA)
Measured: 24months
adverse events
Measured: 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weon Kim, Kyunghee University Medical Center
- Investigators
- Weon Kim, MD, PhD, Principal investigator, Kyunghee University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544932
- Sponsor's protocol ID
- PREFER-AF
- Status last verified
- Sep 2015
- First submitted
- 7 Sep 2015
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim JB, Joung HJ, Lee JM, Woo JS, Kim WS, Kim KS, Lee KH, Kim W. Evaluation of the vascular protective effects of new oral anticoagulants in high-risk patients with atrial fibrillation (PREFER-AF): study protocol for a randomized controlled trial. Trials. 2016 Aug 24;17(1):422. doi: 10.1186/s13063-016-1541-8.
PubMed 27558002
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study for Evaluating Vascular Protective Effects of New Oral Anticoagulants in High Risk Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02544932
- Acronym / sponsor ID
- PREFER-AF
- Conditions
- Atrial Fibrillation
- Keywords
- anticoagulant, atherosclerosis, endothelium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 9 Sep 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.
Atrial fibrillation (AF) has been known to have several pathophysiologic mechanisms including endothelial dysfunction of heart and vessel. This study was designed to determine the efficacy of NOAC therapy in the prevention of endothelial dysfunction and progression of atherosclerosis of AF subjects.
Detailed description
The properties of oral, direct inhibitors of factor Xa (e.g. rivaroxaban) and thrombin (e.g. dabigatran) have been examined the haemostasis and thromboembolism management. Preclinical studies have provided evidences for the effects of direct factor Xa or thrombin inhibition beyond anticoagulation, including anti-inflammatory and protective activities in atherosclerotic plaque development . Therefore, this study evaluates the protective effects of NAOC with the reactive hyperemia peripheral arterial tonometry (RH-PAT) measurements reflecting endothelial function by Endo-PAT2000 and intima-media thickness (IMT) of the carotid artery, which is used as a surrogate endpoint of atherosclerosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dabigatran 110mg or 150mg | Experimental | Drug: dabigatranAfter once enrolled, subjects will be randomized to dabigatran group. (110mg or 150mg twice a day) |
| ribaroxaban 20mg | Experimental | Drug: ribaroxabanAfter once enrolled, subjects will be randomized to ribaroxaban group. (20mg once daily) |
| warfarin | Active comparator | Drug: WarfarinAfter once enrolled, subjects will be randomized to warfarin group. (controlled by INR 2-3) |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- CHA2DS2-VASc score above 2
Key exclusion criteria (9 listed)
- severe peripheral arterial disease (greater than a Fontaine IIb category)
- grade 4 or higher cerebral infarction on the Modified Rankin Scale
- proven coronary artery disease by coronary angiogram
- severe hepatic or renal dysfunction
- uncontrolled congestive heart failure
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 |
|---|---|---|
| dabigatranAlso: pradaxaAfter randomization, patients of this group was will be treated to dabigatran 110mg or 150mg twice a day for 24months | Drug | dabigatran 110mg or 150mg |
| ribaroxabanAlso: xareltoAfter randomization, patients of this group was will be treated to ribaroxaban 20mg once a day for 24months. | Drug | ribaroxaban 20mg |
| WarfarinAfter randomization, patients of this group was will be treated to warfarin and controlled by INR 2-3 for 24months. | Drug | warfarin |
Primary outcome
The changes in reactive hyperemia index (RHI)
Time frame: 12months
3 secondary outcomes
right and left maximum IMT of the common carotid artery (CCA)
Time frame: 24months
right and left mean IMT of the common carotid artery (CCA)
Time frame: 24months
adverse events
Time frame: 24months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2015.
- Derived from this study: PubMed 27558002Kim JB, Joung HJ, Lee JM, Woo JS, Kim WS, Kim KS, Lee KH, Kim W. Evaluation of the vascular protective effects of new oral anticoagulants in high-risk patients with atrial fibrillation (PREFER-AF): study protocol for a randomized controlled trial. Trials. 2016 Aug 24;17(1):422. doi: 10.1186/s13063-016-1541-8.
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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.
Weon Kim, MD, PhD principal investigator
Kyunghee University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dabigatran, ribaroxaban and Warfarin in people with Atrial Fibrillation, run by Kyunghee University Medical Center 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 1 inclusion and 9 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 9 Sep 2015. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Weon Kim, MD, PhD (82-2-958-8170, mylovekw@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes in reactive hyperemia index (RHI) (time frame: 12months). 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 NCT02544932, which also lists 1 linked publication.
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 9 Sep 2015.