A Prospective Randomized Double-Blind Placebo-Controlled Crossover Study to Evaluate the Clinical Utility of the Vascular Health Profile Diagnostics Assay (VHP) in Assessment of Response to Administration of a HMG-CoA reductase inhibitor (statin) as Primary Prevention in Patients with Asymptomatic Atherosclerosis
Brief Description Of Study
This is a prospective, single-center, randomized double-blind, placebo-controlled, crossover study conducted in the United States (US). Patients will be randomized into two treatment sequences (treatment A in period 1, followed by treatment B in period 2, or treatment B in period 1, followed by treatment A in period 2). At the beginning of each period, baseline laboratory and VHP tests will be done, and then again after four weeks of treatment. The two treatment periods will be separated by a four-week washout period. During the first period one of the sequence of subjects will receive drug and the other will receive placebo. Thus, during the second treatment period the treatments will be swapped. Patients and clinical researchers will be blinded with regard to treatment. All subjects who meet the eligibility criteria at the Screening Visit and sign the informed consent form will undergo the study-related procedures. Once the Investigator has reviewed the inclusion/exclusion criteria, the site will contact all subjects to inform them of their eligibility for the study. Subjects deemed ineligible for the study will be documented as screen failures. Following the Screening Visit (-21 to -14 days), each eligible subject will return within 2-3 weeks for Visit 1 (day 1) where the subject will be randomized to either statin or placebo. On day 28 each subject will return for their Visit 2, which completes the first period of the crossover design. The second period will start at Visit 3 (day 58 +/-3 days) and the period will complete at Visit 4 (day 86 +/- 3 days). Thus, following the Screening Visit subjects will on day 1 be randomized to one of two sequences: Daily treatment with statin drug at standard dosage for 4 weeks, followed by 4 weeks of washout, and then, daily treatment with placebo for 4 weeks, or Daily treatment with placebo for 4 weeks followed by 4 weeks of washout, and then, daily treatment with statin drug at standard dosage for 4 weeks At the Screening Visit the following data will be collected: Informed Consent, Medical History, Physical Examination, Weight, Body Mass Index, Cuff Blood Pressure, and blood and urine will be collected for laboratory tests.