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 : Active, not recruiting
First Posted : December 6, 2016
Last Update Posted : December 4, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||October 2020|
|Estimated Study Completion Date :||October 2020|
Previous treatment of aspirin or warfarin will be changed to dabigatran treatment in patients allocated to dabigatran group.
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
Other Name: Coumadin
- 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
- Silent cerebral infarct [ Time Frame: 12 months ]Asymptomatic cerebral infarct confirmed by MRI
- Clinical cerebral infarct [ Time Frame: 12 months ]Symptomatic cerebral infarct
- New cerebral microbleed [ Time Frame: 12 months ]Asymptomatic MRI lesion
- Major bleeding [ Time Frame: 12 months ]
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
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Korea, Republic of, 138-736|
|Principal Investigator:||Duk-Hyun Kang, M.D.||Asan Medical Center|