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

Atrial Fibrillation Clinical Trial

— SPACE  

Official title:

Silent Cerebrovascular Lesion and Cognitive Decline Prevention in Atrial Fibrillation by Intensive Cholesterol Lowering in Elderly Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00449410
• Other study ID #: SPACE1
• 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
• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cerebrovascular Disorders
• Hemostasis
• Inflammation
• Magnetic Resonance Imaging
• Neuropsychology

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