Silent Cerebrovascular Lesion and Cognitive Decline Prevention by Cholesterol Lowering in Elderly AF Patients
NCT00449410
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
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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
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
- 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 |
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| Intervention ICMJE |
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| 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 | 35 | ||||||
| Original Enrollment ICMJE | Same as current | ||||||
| Study Completion Date ICMJE | October 2006 | ||||||
| Primary Completion Date | Not Provided | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||||
| Sex/Gender ICMJE |
| ||||||
| 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 |
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| Investigators ICMJE |
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| 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 | |||||||