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Silent Cerebrovascular Lesion and Cognitive Decline Prevention by Cholesterol Lowering in Elderly AF Patients

Phase 4
Completed
Conditions
Atrial Fibrillation
Neuropsychology
Magnetic Resonance Imaging
Inflammation
Hemostasis
Registration Number
NCT00449410
Lead Sponsor
Radboud University Medical Center
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
35
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Neurocognitive function
Cerebrovascular lesions on MRI
Secondary Outcome Measures
NameTimeMethod
Level of inflammatory markers
Level of hemostatic markers

Trial Locations

Locations (1)

Gheorghe AM Pop

🇳🇱

Nijmegen, Netherlands

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