Atrial Fibrillation, Hemostasis, Inflammation, Magnetic Resonance Imaging, Neuropsychology
Conditions
Keywords
Atrial Fibrillation, elderly, cholesterol lowering, neurocognitive function, cerebrovascular lesion
Brief summary
In elderly patients with atrial fibrillation (AF) the presence of silent brain infarcts and neurocognitive deficit is high despite adequate treatment with oral anticoagulation. Atherosclerosis is considered to be a chronic inflammatory disease and thrombosis and inflammation are strongly correlated. Atrial fibrillation is linked with increased levels of inflammatory markers and intensive cholesterol lowering has proven to reduce inflammation. In a prospective double-blind randomized pilot-study we want to test the hypothesis, that addition of intensive cholesterol lowering treatment besides adequate oral anticoagulation will reduce cerebrovascular lesions and will be beneficial for neurocognitive status in elderly AF patients.
Interventions
DRUGAtorvastatin
DRUGezetimibe
Sponsors
Pfizer
Schering-Plough
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
68 Years to 82 Years
Healthy volunteers
No
Inclusion criteria
* Elderly patients (\>68 and \<82 years) with atrial fibrillation and adequate oral anticoagulation therapy and cholesterol levels between 4,5 mmol/l and 7 mmol/l
Exclusion criteria
* Indication for cholesterol lowering treatment according to Dutch CBO-cholesterol guidelines (2004)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neurocognitive function | — |
| Cerebrovascular lesions on MRI | — |
Secondary
| Measure | Time frame |
|---|---|
| Level of hemostatic markers | — |
| Level of inflammatory markers | — |
Countries
Netherlands
Outcome results
None listed