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

Radboud University Medical Center

Status and phase

Completed

Phase 4

Conditions

Hemostasis

Inflammation

Atrial Fibrillation

Neuropsychology

Magnetic Resonance Imaging

Treatments

Drug: Atorvastatin

Drug: ezetimibe

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00449410

SPACE1

Details and patient eligibility

About

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.

Sex

All

Ages

68 to 82 years old

Volunteers

No Healthy Volunteers

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