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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00449410
Recruitment Status : Completed
First Posted : March 20, 2007
Last Update Posted : March 20, 2007
Information provided by:
Radboud University

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Neuropsychology Magnetic Resonance Imaging Inflammation Hemostasis Drug: Atorvastatin Drug: ezetimibe Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Silent Cerebrovascular Lesion and Cognitive Decline Prevention in Atrial Fibrillation by Intensive Cholesterol Lowering in Elderly Patients
Study Start Date : May 2005
Study Completion Date : October 2006

Primary Outcome Measures :
  1. Neurocognitive function
  2. Cerebrovascular lesions on MRI

Secondary Outcome Measures :
  1. Level of inflammatory markers
  2. Level of hemostatic markers

Information from the National Library of Medicine

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Ages Eligible for Study:   68 Years to 82 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00449410

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Gheorghe AM Pop
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
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Principal Investigator: Janet Kuilenburg, MD UMCN Radboud
Study Director: Gheorghe AM Pop, MD PhD UMCN Radboud

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00449410     History of Changes
Other Study ID Numbers: SPACE1
First Posted: March 20, 2007    Key Record Dates
Last Update Posted: March 20, 2007
Last Verified: March 2007

Keywords provided by Radboud University:
Atrial Fibrillation
cholesterol lowering
neurocognitive function
cerebrovascular lesion

Additional relevant MeSH terms:
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Atrial Fibrillation
Cognitive Dysfunction
Cerebrovascular Disorders
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors