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

NCT00449410

Last updated date
Study Location
Gheorghe AM Pop
Nijmegen, , 6500 HB, Netherlands
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atrial Fibrillation, Neuropsychology, Magnetic Resonance Imaging, Inflammation, Hemostasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
68-82 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

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Atrial Fibrillation, Neuropsychology, Magnetic Resonance Imaging, Inflammation, HemostasisSilent Cerebrovascular Lesion and Cognitive Decline Prevention by Cholesterol Lowering in Elderly AF Patients
NCT00449410
  1. Nijmegen,
ALL GENDERS
68 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Silent Cerebrovascular Lesion and Cognitive Decline Prevention by Cholesterol Lowering in Elderly AF Patients
Official Title  ICMJE Silent Cerebrovascular Lesion and Cognitive Decline Prevention in Atrial Fibrillation by Intensive Cholesterol Lowering in Elderly Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE
  • Atrial Fibrillation
  • Neuropsychology
  • Magnetic Resonance Imaging
  • Inflammation
  • Hemostasis
Intervention  ICMJE
  • Drug: Atorvastatin
  • Drug: ezetimibe
Study Arms  ICMJE Not Provided
Publications * Lappegård 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: March 19, 2007)
35
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE October 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 68 Years to 82 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00449410
Other Study ID Numbers  ICMJE SPACE1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Radboud University
Collaborators  ICMJE
  • Pfizer
  • Schering-Plough
Investigators  ICMJE
Principal Investigator:Janet Kuilenburg, MDUMCN Radboud
Study Director:Gheorghe AM Pop, MD PhDUMCN Radboud
PRS Account Radboud University
Verification Date March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP