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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00449410
Other study ID # SPACE1
Secondary ID
Status Completed
Phase Phase 4
First received March 19, 2007
Last updated March 19, 2007
Start date May 2005
Est. completion date October 2006

Study information

Verified date March 2007
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date October 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 68 Years to 82 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Intervention

Drug:
Atorvastatin

ezetimibe


Locations

Country Name City State
Netherlands Gheorghe AM Pop Nijmegen

Sponsors (3)

Lead Sponsor Collaborator
Radboud University Pfizer, Schering-Plough

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neurocognitive function
Primary Cerebrovascular lesions on MRI
Secondary Level of inflammatory markers
Secondary Level of hemostatic markers
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