Prothrombotic Inflammatory Markers in Women With Metabolic Syndrome - Effect of Atorvastatin (PINK)

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University of Rochester

Status and phase

Phase 2
Phase 1


Metabolic Syndrome


Drug: Atorvastatin
Other: Placebo

Study type


Funder types



Grant# 2004-1035 (Other Grant/Funding Number)
Protocol No. 1988

Details and patient eligibility


Little is known regarding the association of individual components of the metabolic syndrome (MBS) and prothrombotic, inflammatory and preclinical cardiac structural and functional markers in women with this syndrome. Less is known about adequate treatment as the pathological mechanism of this syndrome is not well understood. The purpose of this study is two fold; 1. To determine basic differences in biochemical and cardiovascular structural markers in women with and those without MBS and their association with the individual components of MBS. 2. To determine the impact of atorvastatin to lower the risk factors of Metabolic Syndrome. Atorvastatin is one of the most effective drugs approved by the United States Food and Drug Administration (FDA) for the treatment of high cholesterol. It belongs to a class of drugs called statins and its role in primary prevention is still unclear. Thus this population seems to be an ideal group that may benefit from this intervention.

Full description

The first phase of the study is an observational phase as previously described. The second phase was a prospective evaluation of the effect of a well known "statin" drug (Lipitor) on different biochemical factors measured in the blood. The eligible study participants had blood work done upon enrollment and if criteria was met(according to the Adult Treatment Panel III), they were given dietary counseling (NYHA - New York Heart Association Step 1 diet) as a lead in phase. Lab work was repeated at 3 weeks to evaluate the impact of the diet and if participant's profile still met criteria for MBS,randomization for either atorvastatin (Lipitor) 80mg or placebo (sugar pill) for 12 weeks took place.


116 patients




18 to 75 years old


Accepts Healthy Volunteers

Inclusion criteria

  • Women between the ages of 18-75 with Metabolic syndrome
  • Abdominal circumference > 35 in
  • Hypertriglyceridemia > 150mg/dl
  • HDL <50
  • Blood Pressure >130/85
  • Fasting Glucose >100

Exclusion criteria

  • Pregnant or planning to become pregnant in the next 6-12 months
  • Receiving lipid-lowing drugs
  • Obstructive hepatobiliary disease or serious hepatic disease
  • Diabetes, cardiovascular disease (CVD), hypothyroidism, active infection, cancer, recent surgery
  • Fulfill criteria to receive statin based on LDL levels, risk factors, and Framingham risk scoring outlined on ATP111/NCEP 111 recommendations
  • Documented allergic reaction to statin in past
  • unexplained elevation in creatinine kinase levels > 3 times upper limit

Trial design

Primary purpose




Interventional model

Parallel Assignment


Double Blind

116 participants in 2 patient groups, including a placebo group

Experimental group
44 women randomized to 80 mg atorvastatin for 6weeks
Drug: Atorvastatin
sugar pill
Placebo Comparator group
44 women randomized to placebo for 6 weeks
Other: Placebo

Trial contacts and locations



Data sourced from

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