Atrial FibrillationPhase 4DECISIVENCT02982850
Dabigatran Versus Conventional Treatment for Prevention of Silent Cerebral Infarct in Atrial Fibrillation Associated With Valvular Disease
A Phase 4 study testing Dabigatran, Acetylsalicylic acid and Warfarin in people with Atrial Fibrillation and Valve Heart Disease, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The prevalence of AF, which is tachyarrhythmia, is approximately 2% of the entire population and 5% of the population at the age of 60 or older. AF is the cause of approximately 20% of all events of ischemic stroke, and patients with AF are known to be at 6 to 10% risk of ischemic stroke per year. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atrial Fibrillation, Valve Heart Disease
- What is being tested?
- Dabigatran, Acetylsalicylic acid and Warfarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2016to Oct 2020
- Phase
- Phase 4
- 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
- Voluntary informed consent
- Diagnosis of AF
- Aortic valvular stenosis, aortic valvular regurgitation, mitral valvular stenosis, or mitral valvular regurgitation of moderate or above severity
- Patients must have one of the following:
- Hypertension requiring medical treatment
- Symptomatic heart failure, New York Heart Association class 2 or higher in the last 6 mon or ejection fraction <40% documented by echocardiogram
Show all 11Show fewer
- Age ≥ 65 years
- Diabetes mellitus on treatment
- History of previous stroke, transient ischemic attack, or systemic embolism
- Previous myocardial infarct, peripheral artery disease, or aortic plaque
- Enlarged left atrial size ≥ 40mm documented by echocardiogram
Who cannot join
- An individual involved in planning or conducting this study
- Unable to understand study conduct or study compliance due to dementia, etc.
- Lack of ability to communicate
- Pregnant woman
- Past cardiac valve replacement
- Stroke resulting in severe disabilities within the past 6 months
Show all 28Show fewer
- Stroke including silent cerebral infarct within the past 2 weeks
- Chronic renal failure with creatinine clearance < 30ml/min
- Active hepatitis (≥2 fold increase in liver enzyme levels, known active hepatitis C, active hepatitis B, active hepatitis A)
- High bleeding risk
- Major surgery within the past 1 month
- Planned surgery or procedure within 3 months
- Intracranial, intraocular, intraspinal, or retroperitoneal bleeding history or atraumatic joint bleeding history
- Digestive tract bleeding within the past 1 year
- Symptomatic or endoscopically confirmed gastric or duodenal ulcer within the past 30 days
- Hematologic abnormalities
- Requiring anticoagulant treatment for any reasons other than AF
- Requiring antithrombotics within 48 hours of start of the study
- Uncontrolled hypertension (systolic blood pressure ≥180mmHg or diastolic blood pressure ≥100mmHg)
- Recent malignant tumor or 6 months or longer treatment with radiation therapy
- Mean life expectancy ≤3 years
- Contraindication of anticoagulant treatment
- Screening test results as follows
- Platelet count <80,000 cells/mm3
- Hemoglobin level <10g/dL
- Previous experience of major bleeding complications
- Participation in another drug study within 3 months prior to enrollment to this study
- Administration of the study drug within 1 month prior to enrollment to this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Dabigatran Versus Conventional Treatment for Prevention of Silent Cerebral Infarct in Aortic and Mitral Valvular Atrial Fibrillation Patients
The prevalence of AF, which is tachyarrhythmia, is approximately 2% of the entire population and 5% of the population at the age of 60 or older. AF is the cause of approximately 20% of all events of ischemic stroke, and patients with AF are known to be at 6 to 10% risk of ischemic stroke per year. Patients with valvular AF are known to have a higher incidence of stroke than patients with nonvalvular AF. However, the relevant data are insufficient as large randomized studies comparing NOAC treatment with warfarin, a conventional treatment, did not include many patients with moderate and severe valvular AF.
Ischemic stroke is divided into symptomatic stroke with brain lesions on brain magnetic resonance imaging (MRI) and silent cerebral infarct with lesions on brain MRI but without stroke symptoms. According to a brain MRI follow-up study, the incidence of silent cerebral infarct was 17.7% (254 subjects) over a period of 5 years, with 11.4% of 254 subjects reporting to have experienced symptoms. This means that the incidence of silent cerebral infarct is approximately 9 times that of symptomatic stroke. In addition, patients with a history of silent cerebral infarct are known to be approximately twice more likely to experience stroke in the future than those without a history of silent. Brain microbleed is easily detected by brain MRI and is a well-known independent predictor of intraparenchymal hemorrhage and silent cerebral infarct. The prevention of stroke by the study drug can be indirectly assessed based on the incidence of silent cerebral infarct and brain microbleed on brain MRI. Investigators tried to compare effect of dabigatran with conventional treatment in terms of prevention of stroke by comparing incidences of silent cerebral infarct and brain microbleed and symptomatic stroke using brain MRI.
Read the detailed description
Amongst different types of cardiac arrhythmia, tachyarrhythmia shows the highest prevalence. The prevalence of AF, which is tachyarrhythmia, is approximately 2% of the entire population and 5% of the population at the age of 60 or older. AF is the cause of approximately 20% of all events of ischemic stroke, and patients with AF are known to be at 6 to 10% risk of ischemic stroke per year. In addition, AF results in heart failure and doubles mortalities. With an increase in the elderly population, there is a worldwide trend of increased hospitalization rate and medical cost caused by cardiac arrhythmia. In addition, whereas AF has been known to occur mainly in the elderly, the incidence of AF is also increasing in younger population, which is thought to be associated with the increased prevalence of heart diseases, dietary changes, and increased environmental pollution.
- Previous studies related to atrial fibrillation and stroke i. While AF is characterized by a single electrophysiological abnormality, depending on cases, the risk of stroke varies from below 1%/year to 20%/year or above. ii. New oral anticoagulant (NOAC), left atrial appendage occlusion, etc. have been studied as treatments to replace warfarin and aspirin and their effects have been also demonstrated.
- Relevant study trends and limitations i. Patients with valvular AF are known to have a higher incidence of stroke than patients with nonvalvular AF. However, the relevant data are insufficient as large randomized studies comparing NOAC treatment with warfarin, a conventional treatment, did not include many patients with moderate and severe valvular AF. ii. The exclusion of valvular AF from the study is based on the assumption that the pathogenesis of thromboembolism would vary according to the type of AF. However, the difference in pathogenesis of thromboembolism between valvular AF and nonvalvular AF remains unknown.
- Study features i. Ischemic stroke is divided into symptomatic stroke with brain lesions on brain magnetic resonance imaging (MRI) and silent cerebral infarct with lesions on brain MRI but without stroke symptoms. ii. According to a brain MRI follow-up study, the incidence of silent cerebral infarct was 17.7% (254 subjects) over a period of 5 years, with 11.4% of 254 subjects reporting to have experienced symptoms. This means that the incidence of silent cerebral infarct is approximately 9 times that of symptomatic stroke. iii. In addition, patients with a history of silent cerebral infarct are known to be approximately twice more likely to experience stroke in the future than those without a history of silent. iv. Brain microbleed is easily detected by brain MRI and is a well-known independent predictor of intraparenchymal hemorrhage and silent cerebral infarct.
- The prevention of stroke by the study drug can be indirectly assessed based on the incidence of silent cerebral infarct and brain microbleed on brain MRI at the start of study and at 1 year follow-up.
- Significance of the study i. The incidence of stroke is higher in valvular AF than in nonvalvular AF. ii. There is lack of data on dabigatran treatment, an NOAC, in valvular AF. iii. To compare dabigatran with conventional treatment in terms of prevention of stroke by comparing incidences of silent cerebral infarct and brain microbleed and symptomatic stroke at the start of study and at 1 year follow-up using brain MRI.
This is a single center, prospective, randomized study to evaluate the effectiveness and safety of dabigatran versus conventional treatment in patients with valvular AF by comparing the incidence of silent cerebral infarct and brain microbleed using brain MRI. Aspirin or warfarin treatment will be continued in patients randomly allocated to conventional treatment group, and changed to dabigatran treatment in those randomly allocated to dabigatran group.
- Conditions
- Atrial Fibrillation, Valve Heart Disease
- Being tested
- Dabigatran, Acetylsalicylic acid, Warfarin
- Keywords
- Atrial Fibrillation, Valvular Insufficiency, Valvular Stenosis
- Medical subject headings
- Atrial Fibrillation, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DabigatranDrug
Also called Pradaxa
Acetylsalicylic acidDrug
Also called Aspirin
WarfarinDrug
Also called Coumadin
| Study group | Role | What they receive |
|---|---|---|
| Dabigatran | Experimental | Previous treatment of aspirin or warfarin will be changed to dabigatran treatment in patients allocated to dabigatran group. Receives: Drug: Dabigatran |
| Conventional Treatment | Active comparator | Acetylsalicylic acid or warfarin treatment will be continued in patients allocated to conventional treatment group. Receives: Drug: Acetylsalicylic acid; Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of clinical cerebral infarct or new cerebral MRI lesions
Number of patients who develop clinical symptomatic cerebral infarct or new cerebral MR lesion, including silent cerebral infarct and microbleed
Measured: 12 months
Secondary outcomes (4)
Silent cerebral infarct
Asymptomatic cerebral infarct confirmed by MRI
Measured: 12 months
Clinical cerebral infarct
Symptomatic cerebral infarct
Measured: 12 months
New cerebral microbleed
Asymptomatic MRI lesion
Measured: 12 months
Major bleeding
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionOct 2020
- Study completionOct 2020
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 Asan Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Principal investigator, Duk-Hyun Kang, Asan Medical Center
- Investigators
- Duk-Hyun Kang, M.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982850
- Sponsor's protocol ID
- 2016-0869
- Acronym
- DECISIVE
- Status last verified
- Jan 2021
- First submitted
- 29 Nov 2016
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Dabigatran Versus Conventional Treatment for Prevention of Silent Cerebral Infarct in Aortic and Mitral Valvular Atrial Fibrillation Patients
- ClinicalTrials.gov ID
- NCT02982850
- Acronym / sponsor ID
- DECISIVE / 2016-0869
- Conditions
- Atrial Fibrillation, Valve Heart Disease
- Keywords
- Atrial Fibrillation, Valvular Insufficiency, Valvular Stenosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- Dec 2016
- Primary completion
- Oct 2020 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 6 Dec 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.
The prevalence of AF, which is tachyarrhythmia, is approximately 2% of the entire population and 5% of the population at the age of 60 or older. AF is the cause of approximately 20% of all events of ischemic stroke, and patients with AF are known to be at 6 to 10% risk of ischemic stroke per year. Patients with valvular AF are known to have a higher incidence of stroke than patients with nonvalvular AF. However, the relevant data are insufficient as large randomized studies comparing NOAC treatment with warfarin, a conventional treatment, did not include many patients with moderate and severe valvular AF.
Ischemic stroke is divided into symptomatic stroke with brain lesions on brain magnetic resonance imaging (MRI) and silent cerebral infarct with lesions on brain MRI but without stroke symptoms. According to a brain MRI follow-up study, the incidence of silent cerebral infarct was 17.7% (254 subjects) over a period of 5 years, with 11.4% of 254 subjects reporting to have experienced symptoms. This means that the incidence of silent cerebral infarct is approximately 9 times that of symptomatic stroke. In addition, patients with a history of silent cerebral infarct are known to be approximately twice more likely to experience stroke in the future than those without a history of silent. Brain microbleed is easily detected by brain MRI and is a well-known independent predictor of intraparenchymal hemorrhage and silent cerebral infarct. The prevention of stroke by the study drug can be indirectly assessed based on the incidence of silent cerebral infarct and brain microbleed on brain MRI. Investigators tried to compare effect of dabigatran with conventional treatment in terms of prevention of stroke by comparing incidences of silent cerebral infarct and brain microbleed and symptomatic stroke using brain MRI.
Detailed description
Amongst different types of cardiac arrhythmia, tachyarrhythmia shows the highest prevalence. The prevalence of AF, which is tachyarrhythmia, is approximately 2% of the entire population and 5% of the population at the age of 60 or older. AF is the cause of approximately 20% of all events of ischemic stroke, and patients with AF are known to be at 6 to 10% risk of ischemic stroke per year. In addition, AF results in heart failure and doubles mortalities. With an increase in the elderly population, there is a worldwide trend of increased hospitalization rate and medical cost caused by cardiac arrhythmia. In addition, whereas AF has been known to occur mainly in the elderly, the incidence of AF is also increasing in younger population, which is thought to be associated with the increased prevalence of heart diseases, dietary changes, and increased environmental pollution.
- Previous studies related to atrial fibrillation and stroke i. While AF is characterized by a single electrophysiological abnormality, depending on cases, the risk of stroke varies from below 1%/year to 20%/year or above. ii. New oral anticoagulant (NOAC), left atrial appendage occlusion, etc. have been studied as treatments to replace warfarin and aspirin and their effects have been also demonstrated.
- Relevant study trends and limitations i. Patients with valvular AF are known to have a higher incidence of stroke than patients with nonvalvular AF. However, the relevant data are insufficient as large randomized studies comparing NOAC treatment with warfarin, a conventional treatment, did not include many patients with moderate and severe valvular AF. ii. The exclusion of valvular AF from the study is based on the assumption that the pathogenesis of thromboembolism would vary according to the type of AF. However, the difference in pathogenesis of thromboembolism between valvular AF and nonvalvular AF remains unknown.
- Study features i. Ischemic stroke is divided into symptomatic stroke with brain lesions on brain magnetic resonance imaging (MRI) and silent cerebral infarct with lesions on brain MRI but without stroke symptoms. ii. According to a brain MRI follow-up study, the incidence of silent cerebral infarct was 17.7% (254 subjects) over a period of 5 years, with 11.4% of 254 subjects reporting to have experienced symptoms. This means that the incidence of silent cerebral infarct is approximately 9 times that of symptomatic stroke. iii. In addition, patients with a history of silent cerebral infarct are known to be approximately twice more likely to experience stroke in the future than those without a history of silent. iv. Brain microbleed is easily detected by brain MRI and is a well-known independent predictor of intraparenchymal hemorrhage and silent cerebral infarct.
- The prevention of stroke by the study drug can be indirectly assessed based on the incidence of silent cerebral infarct and brain microbleed on brain MRI at the start of study and at 1 year follow-up.
- Significance of the study i. The incidence of stroke is higher in valvular AF than in nonvalvular AF. ii. There is lack of data on dabigatran treatment, an NOAC, in valvular AF. iii. To compare dabigatran with conventional treatment in terms of prevention of stroke by comparing incidences of silent cerebral infarct and brain microbleed and symptomatic stroke at the start of study and at 1 year follow-up using brain MRI.
This is a single center, prospective, randomized study to evaluate the effectiveness and safety of dabigatran versus conventional treatment in patients with valvular AF by comparing the incidence of silent cerebral infarct and brain microbleed using brain MRI. Aspirin or warfarin treatment will be continued in patients randomly allocated to conventional treatment group, and changed to dabigatran treatment in those randomly allocated to dabigatran group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dabigatran | Experimental | Drug: DabigatranPrevious treatment of aspirin or warfarin will be changed to dabigatran treatment in patients allocated to dabigatran group. |
| Conventional Treatment | Active comparator | Drug: Acetylsalicylic acid, Drug: WarfarinAcetylsalicylic acid or warfarin treatment will be continued in patients allocated to conventional treatment group. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Voluntary informed consent
- Diagnosis of AF
- Aortic valvular stenosis, aortic valvular regurgitation, mitral valvular stenosis, or mitral valvular regurgitation of moderate or above severity
- Patients must have one of the following:
Key exclusion criteria (28 listed)
- An individual involved in planning or conducting this study
- Unable to understand study conduct or study compliance due to dementia, etc.
- Lack of ability to communicate
- Pregnant woman
- Past cardiac valve replacement
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: Pradaxa | Drug | Dabigatran |
| Acetylsalicylic acidAlso: Aspirin | Drug | Conventional Treatment |
| WarfarinAlso: Coumadin | Drug | Conventional Treatment |
Primary outcome
Composite of clinical cerebral infarct or new cerebral MRI lesions
Time frame: 12 months
Number of patients who develop clinical symptomatic cerebral infarct or new cerebral MR lesion, including silent cerebral infarct and microbleed
4 secondary outcomes
Silent cerebral infarct
Time frame: 12 months
Clinical cerebral infarct
Time frame: 12 months
New cerebral microbleed
Time frame: 12 months
Major bleeding
Time frame: 12 months
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 13 Jan 2021.
- 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.
Duk-Hyun Kang, M.D. principal investigator
Asan 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 4 study testing Dabigatran, Acetylsalicylic acid and Warfarin in people with Atrial Fibrillation and Valve Heart Disease, run by Asan 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 11 inclusion and 28 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 Jan 2021. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Composite of clinical cerebral infarct or new cerebral MRI lesions (time frame: 12 months). 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 13 Jan 2021.