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OpenTrials
Completed

NCT Number: NCT00449410

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Hemostasis Inflammation Magnetic Resonance Imaging Nervous System Diseases Neuropsychology Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

68 year–82 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gheorghe AM Pop

Nijmegen, 6500 HB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

atorvastatin

Drug

ezetimibe

Drug

Primary outcomes

  1. Neurocognitive function

  2. Cerebrovascular lesions on MRI

Secondary outcomes

  1. Level of inflammatory markers

  2. Level of hemostatic markers

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Pfizer
  • Schering-Plough

Registry information

Official study title

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

Acronym: SPACE

Important dates

Study start
2005
Study completion
2006
First posted
Mar 20, 2007
Registry last updated
Mar 20, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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