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Dabigatran Versus Conventional Treatment for Prevention of Silent Cerebral Infarct in Atrial Fibrillation Associated With Valvular Disease (DECISIVE)

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ClinicalTrials.gov Identifier: NCT02982850
Recruitment Status : Recruiting
First Posted : December 6, 2016
Last Update Posted : January 9, 2018
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Duk-Hyun Kang, Asan Medical Center

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Valve Heart Disease Drug: Dabigatran Drug: Acetylsalicylic acid Drug: Warfarin Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Dabigatran Versus Conventional Treatment for Prevention of Silent Cerebral Infarct in Aortic and Mitral Valvular Atrial Fibrillation Patients
Study Start Date : December 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: Dabigatran
Previous treatment of aspirin or warfarin will be changed to dabigatran treatment in patients allocated to dabigatran group.
Drug: Dabigatran
Other Name: Pradaxa

Active Comparator: Conventional Treatment
Acetylsalicylic acid or warfarin treatment will be continued in patients allocated to conventional treatment group.
Drug: Acetylsalicylic acid
Other Name: Aspirin

Drug: Warfarin
Other Name: Coumadin




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Silent cerebral infarct [ Time Frame: 12 months ]
    Asymptomatic cerebral infarct confirmed by MRI

  2. Clinical cerebral infarct [ Time Frame: 12 months ]
    Symptomatic cerebral infarct

  3. New cerebral microbleed [ Time Frame: 12 months ]
    Asymptomatic MRI lesion

  4. Major bleeding [ Time Frame: 12 months ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
    • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02982850


Contacts
Contact: Duk-Hyun Kang, M.D. 82-2-3010-3166 dhkang@amc.seoul.kr
Contact: Kee-Joon Choi, M.D. 82-2-3010-3167 kjchoi@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Duk Hyun Kang, MD, PhD    82-2-3010-3166    dhkang@amc.seoul.kr   
Contact: Sahmin Lee, MD    82-2-3010-3165    sahmin.lee@amc.seoul.kr   
Principal Investigator: Duk Hyun Kang, MD, PhD         
Sponsors and Collaborators
Asan Medical Center
Boehringer Ingelheim
Investigators
Principal Investigator: Duk-Hyun Kang, M.D. Asan Medical Center

Responsible Party: Duk-Hyun Kang, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02982850     History of Changes
Other Study ID Numbers: 2016-0869
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Duk-Hyun Kang, Asan Medical Center:
Atrial Fibrillation
Valvular Insufficiency
Valvular Stenosis

Additional relevant MeSH terms:
Heart Valve Diseases
Atrial Fibrillation
Heart Diseases
Cerebral Infarction
Arrhythmias, Cardiac
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Aspirin
Dabigatran
Warfarin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors