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

NCT00449410 | Completed Phase 4

• 1 other identifier: SPACE1
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Neuropsychology; Magnetic Resonance Imaging; Inflammation; Hemostasis

Keywords

Atrial Fibrillation; elderly; cholesterol lowering; neurocognitive function; cerebrovascular lesion

Outcome Measures

Primary Outcomes (2)

• Neurocognitive function

• Cerebrovascular lesions on MRI

Secondary Outcomes (2)

• Level of inflammatory markers

• Level of hemostatic markers

Interventions

Atorvastatin DRUG

ezetimibe DRUG

Eligibility Criteria

• Age: 68 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Indication for cholesterol lowering treatment according to Dutch CBO-cholesterol guidelines (2004)

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Pfizer: collaborator
• Schering-Plough: collaborator

Study Sites (1)

Gheorghe AM Pop

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (1)

• Lappegard KT, Pop-Purceleanu M, van Heerde W, Sexton J, Tendolkar I, Pop G. Improved neurocognitive functions correlate with reduced inflammatory burden in atrial fibrillation patients treated with intensive cholesterol lowering therapy. J Neuroinflammation. 2013 Jun 28;10:78. doi: 10.1186/1742-2094-10-78.

  PMID: 23809138 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Inflammation; Cerebrovascular Disorders

Interventions

Atorvastatin; Ezetimibe

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Azetidines; Azetines

Study Officials

• Janet Kuilenburg, MD

  UMCN Radboud

  PRINCIPAL INVESTIGATOR

• Gheorghe AM Pop, MD PhD

  UMCN Radboud

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 19, 2007
• First Posted: March 20, 2007
• Study Start: May 1, 2005
• Study Completion: October 1, 2006
• Last Updated: March 20, 2007

Record last verified: 2007-03

Locations

NL (1)