Cholesterol and Pharmacogenetic Study (CAP)

UCSF Benioff Children's Hospital Oakland

Status and phase

Completed

Phase 4

Conditions

Coronary Heart Disease

Hyperlipidemia

Hypercholesterolemia

Cardiovascular Disease

Treatments

Drug: Simvastatin

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00451828

MM2277

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,000 estimated patients

Sex

All

Ages

30+ years old

Volunteers

Accepts Healthy Volunteers

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