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

Primary Purpose

Atrial Fibrillation, Neuropsychology, Magnetic Resonance Imaging

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Atorvastatin
ezetimibe
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, elderly, cholesterol lowering, neurocognitive function, cerebrovascular lesion

Eligibility Criteria

68 Years - 82 Years (Older Adult)All SexesDoes not accept 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:

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

Sites / Locations

  • Gheorghe AM Pop

Outcomes

Primary Outcome Measures

Neurocognitive function
Cerebrovascular lesions on MRI

Secondary Outcome Measures

Level of inflammatory markers
Level of hemostatic markers

Full Information

First Posted
March 19, 2007
Last Updated
March 19, 2007
Sponsor
Radboud University Medical Center
Collaborators
Pfizer, Schering-Plough
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1. Study Identification

Unique Protocol Identification Number
NCT00449410
Brief Title
Silent Cerebrovascular Lesion and Cognitive Decline Prevention by Cholesterol Lowering in Elderly AF Patients
Acronym
SPACE
Official Title
Silent Cerebrovascular Lesion and Cognitive Decline Prevention in Atrial Fibrillation by Intensive Cholesterol Lowering in Elderly Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Radboud University Medical Center
Collaborators
Pfizer, Schering-Plough

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Neuropsychology, Magnetic Resonance Imaging, Inflammation, Hemostasis
Keywords
Atrial Fibrillation, elderly, cholesterol lowering, neurocognitive function, cerebrovascular lesion

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
35 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Type
Drug
Intervention Name(s)
ezetimibe
Primary Outcome Measure Information:
Title
Neurocognitive function
Title
Cerebrovascular lesions on MRI
Secondary Outcome Measure Information:
Title
Level of inflammatory markers
Title
Level of hemostatic markers

10. Eligibility

Sex
All
Minimum Age & Unit of Time
68 Years
Maximum Age & Unit of Time
82 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet Kuilenburg, MD
Organizational Affiliation
UMCN Radboud
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gheorghe AM Pop, MD PhD
Organizational Affiliation
UMCN Radboud
Official's Role
Study Director
Facility Information:
Facility Name
Gheorghe AM Pop
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
23809138
Citation
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.
Results Reference
derived

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

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