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

NCT00449410 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2007-03-20

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Atorvastatin

DRUG

ezetimibe

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Schering-Plough

    collaborator INDUSTRY

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Janet Kuilenburg, MD · UMCN Radboud

  • Gheorghe AM Pop, MD PhD · UMCN Radboud

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
68 Years
Max Age
82 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Completion
2006-10-31

Countries

  • Netherlands

Study Locations

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Entities

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00449410 on ClinicalTrials.gov