Crossover of Higher Dose Statins in Patients With Low High-density Lipoproteins Cholesterol (HDLc)
Effects of High Dose Simvastatin vs. Atorvastatin on Baseline Lipoprotein Profiles, Apo-A-1 and C Reactive Protein
1 other identifier
interventional
80
1 country
1
Brief Summary
Summary: Background: There is a lot of interest in the function and role of HDL to prevent and mitigate atherosclerosis in patients who are at or near LDLc targets. Statins have variable effects on HDLc which are accentuated in patients with a low baseline HDLc. Higher doses of statins are being used more commonly in practice based on newer outcomes studies which find greater benefits of the higher doses compared to lower or standard doses. This study is testing FDA approved dosages of two commonly used statin medications. Design: The study is designed to examine the effects of 80mg simvastatin and 80mg atorvastatin on HDLc concentrations. Serum will be saved for a hopeful collaborative effort with investigators at the U. of Washington who are able to do more advanced testing of HDL particle functionality. Based on the first 13 patients studied at Indiana University, the effects of these statins on HDLc concentrations vary greatly. It is unknown what impact these concentration changes have on the functionality of the particles however. A meta-analysis of 4 prospective trials published in JAMA in 2006 found that increasing HDLc with statins was independently associated with regression of atherosclerosis as measured by intravascular ultrasound. Patients: Patients with low HDLc will be the primary population recruited. Exclusion criteria include interacting medications, pregnancy, baseline hepatic disease or other illnesses which would put patients at increased risk of statin side effects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 14, 2008
CompletedFirst Posted
Study publicly available on registry
August 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedJuly 22, 2011
August 1, 2008
7 years
August 14, 2008
July 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HDL cholesterol
6 weeks
Secondary Outcomes (1)
HS-CRP, apolipoprotein A1 and B
6 weeks
Study Arms (2)
1
ACTIVE COMPARATORAimvastatin 80 mg
2
ACTIVE COMPARATORAtorvastatin 80 mg
Interventions
Eligibility Criteria
You may qualify if:
- years of age or older
- Screening visit HDL-c cholesterol \< 40 mg/dL (men) or \< 50 mg/dL (women)
- Screening visit LDL-c or non-HDL-c (for patients with TG 200-500 mg/dL) in range requiring therapy based on National Cholesterol Education Program (NCEP) guidelines
- Identifiable primary care provider
- Working phone number for follow-up
You may not qualify if:
- Age \< 18 years
- Any unstable coronary disease (angina) at the screening visit or any acute coronary syndrome \< 6 months prior to first study visit
- Screening TG \> 750 mg/dL
- Known allergy or contraindication to atorvastatin or simvastatin
- Known HIV/AIDS diagnosis
- Screening alanine aminotransferase (ALT) \> 3 times upper lab reference range (ULR)
- Known history or diagnosis of clinical hepatic failure (example: variceal bleeding, ascites, INR\>1.3)
- Self-reported weekly alcohol intake of \> 2 drinks per day on average (e.g. \> 14 drinks/week)
- Self- reported pregnancy or current breastfeeding
- Use of a fibrate or niacin product or any other drug listed in the Zocor or Lipitor product package insert at a dose which causes a significant drug interaction
- Anticipated inability to complete the 4-visit study timeline for any reason (expected prolonged travel, extenuating medical needs, etc.)
- Active participation in another research protocol which would interfere with this trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oregon Health and Science Universitylead
- Merck Sharp & Dohme LLCcollaborator
- Oregon State Universitycollaborator
- Indiana Universitycollaborator
Study Sites (1)
OHSU Hospital
Portland, Oregon, 97239, United States
Related Publications (1)
Deeg MA, Raikwar NS, Johnson C, Williams CD. Statin therapy reduces serum levels of glycosylphosphatidylinositol-specific phospholipase D. Transl Res. 2007 Sep;150(3):153-7. doi: 10.1016/j.trsl.2007.03.008. Epub 2007 May 25.
PMID: 17761367RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Craig D Williams
Oregon Health and Science University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 14, 2008
First Posted
August 15, 2008
Study Start
January 1, 2005
Primary Completion
January 1, 2012
Last Updated
July 22, 2011
Record last verified: 2008-08