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Cholesterol and Pharmacogenetic Study (CAP)

This study has been completed.
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
San Francisco General Hospital
University of California, Los Angeles
Cedars-Sinai Medical Center
University of Washington
Duke University
Information provided by:
Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier:
NCT00451828
First received: March 23, 2007
Last updated: October 4, 2011
Last verified: October 2011
History of Changes
  Purpose

The overall objective of the CAP study was to determine genetic influences on efficacy of simvastatin treatment with regard to LDL cholesterol reduction and changes in other markers of cardiovascular disease risk.


Condition Intervention Phase
Hyperlipidemia
Hypercholesterolemia
Coronary Heart Disease
Cardiovascular Disease
 Drug: Simvastatin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Cholesterol and Pharmacogenetic Study

Resource links provided by NLM:

Drug Information available for: Simvastatin
U.S. FDA Resources

Further study details as provided by Children's Hospital & Research Center Oakland:

Primary Outcome Measures:
  • Total Cholesterol [ Time Frame: -2, 0, 4, 6 weeks ] [ Designated as safety issue: No ]
  • LDL Cholesterol [ Time Frame: -2, 0, 4, 6 weeks ] [ Designated as safety issue: No ]
  • HDL Cholesterol [ Time Frame: -2, 0, 4, 6 weeks ] [ Designated as safety issue: No ]
  • Triglycerides [ Time Frame: -2, 0, 4, 6 weeks ] [ Designated as safety issue: No ]
  • C-reactive protein [ Time Frame: -2, 0, 4, 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total Cholesterol/HDL Cholesterol [ Time Frame: -2, 0, 4, 6 weeks ] [ Designated as safety issue: No ]
  • Apolipoprotein B [ Time Frame: -2, 0, 4, 6 weeks ] [ Designated as safety issue: No ]
  • Apolipoprotein AI [ Time Frame: -2, 0, 4, 6 weeks ] [ Designated as safety issue: No ]
  • Apolipoprotein CIII [ Time Frame: -2, 0, 4, 6 weeks ] [ Designated as safety issue: No ]
  • LDL Peak Particle size [ Time Frame: -2, 0, 4, 6 weeks ] [ Designated as safety issue: No ]
  • LDL Subfractions [ Time Frame: -2, 0, 4, 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: March 2002
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Simvastatin
    40mg/day
Detailed Description:

Despite widespread use of statin therapy for reducing risk of cardiovascular disease risk, there is considerable inter-individual variation in statin efficacy, and it would be desirable to identify markers that would be predictive of the magnitude of beneficial response. The effect of statin most strongly associated with improved clinical outcomes is reduction in LDL cholesterol. The CAP study was a six week non-randomized, open label study of simvastatin 40 mg/day in a group of 335 African-American and 609 Caucasian volunteer subjects. Measurements of plasma lipids and lipoproteins, as well as other markers of cardiovascular disease risk, were obtained at the screening and entry visits, and after four and six weeks of simvastatin treatment. Both baseline measurements and changes in response to simvastatin therapy are being used to test for associations with genetic polymorphisms. Significant findings are being replicated in other study cohorts.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • at least 30 years of age
  • Total Cholesterol between 160 to 400 mg/dl
  • > 3 grandparents of African-American descent or > 3 grandparents of Caucasian descent
  • serum triglycerides < 400 mg/dl
  • fasting glucose < 126 mg/dl

Exclusion Criteria:

  • Use of lipid-lowering medication
  • Use of over-the-counter products containing sterol or stanol esters or fish oil
  • Recent or planned change in dietary intake or weight change of more than 4.5 kg
  • Use of corticosteroids, immunosuppressive drugs or drugs affecting the CYP3A4 system
  • Known liver disease or elevated transaminase levels
  • Elevated creatine phosphokinase levels > 10 times upper limits of normal
  • Uncontrolled blood pressure, or diabetes mellitus
  • Abnormal renal or thyroid function
  • Current alcohol or drug abuse
  • Major illness in the preceding three months
  • Pregnancy
  • Know intolerance to statins
  • Racial ancestry other than African-American or Caucasian
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00451828

Locations
United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
Children's Hospital & Research Center Oakland
National Heart, Lung, and Blood Institute (NHLBI)
San Francisco General Hospital
University of California, Los Angeles
Cedars-Sinai Medical Center
University of Washington
Duke University
Investigators
Principal Investigator: Ronald M Krauss, M.D. Children's Hospital & Research Center Oakland
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ronald M. Krauss, MD, Children's Hospital Oakland Research Institute
ClinicalTrials.gov Identifier: NCT00451828     History of Changes
Other Study ID Numbers: MM2277
Study First Received: March 23, 2007
Last Updated: October 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital & Research Center Oakland:
Statins
Cholesterol
Pharmacogenetics

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Hypercholesterolemia
Hyperlipidemias
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
 Metabolic Diseases
Simvastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013