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

NCT02982850 | Completed Phase 4 DMC

• 1 other identifier: 2016-0869
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Valve Heart Disease

Keywords

Atrial Fibrillation; Valvular Insufficiency; Valvular Stenosis

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (4)

• Silent cerebral infarct

  12 months

• Clinical cerebral infarct

  12 months

• New cerebral microbleed

  12 months

• Major bleeding

  12 months

Study Arms (2)

Dabigatran

EXPERIMENTAL

Previous treatment of aspirin or warfarin will be changed to dabigatran treatment in patients allocated to dabigatran group.

Drug: Dabigatran

Conventional Treatment

ACTIVE COMPARATOR

Acetylsalicylic acid or warfarin treatment will be continued in patients allocated to conventional treatment group.

Drug: Acetylsalicylic acid; Drug: Warfarin

Interventions

Dabigatran DRUG

Also known as: Pradaxa

Dabigatran

Acetylsalicylic acid DRUG

Also known as: Aspirin

Conventional Treatment

Warfarin DRUG

Also known as: Coumadin

Conventional Treatment

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation; Heart Valve Diseases

Interventions

Dabigatran; Aspirin; Warfarin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans

Study Officials

• Duk-Hyun Kang, M.D.

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: December 6, 2016
• Study Start: December 1, 2016
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: January 13, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)