Rationale, design, and baseline characteristics of a trial of prevention of cardiovascular and renal disease with Fosinopril and Pravastatin in nonhypertensive, nonhypercholesterolemic subjects with microalbuminuria (the Prevention of REnal and Vascular ENdstage Disease Intervention Trial [PREVEND IT])

This study describes the rationale, design, and baseline characteristics of a trial to determine whether treatment with fosinopril 20 mg/day and/or pr avastatin 40 mg/day will prevent cardiovascular and renal disease in nonhyp ertensive (RR <160/100 mm Hg and not using antihypertensive medication) and nonhypercholesterolemic (total cholesterol <8.0 or <5.0 mmol/L in case of previous myocardial infarction and not using lipid lowering medication) men and women with persistent microalbuminuria (urinary albumin excretion >10 mg/L once in an early morning spot urine and 15 to 300 mg/24-hour at least once in two 24-hour urine collections). The Prevention of REnal and Vascula r ENdstage Disease Intervention Trial is a single-center, double-blind, ran domized, placebo-controlled trial with a 2 x 2 factorial design. The 864 ra ndomized subjects will be monitored for a minimum of 4 years and a maximum of 5 years. The primary efficacy parameter is defined as the combined incid ence of all-cause mortality or hospital admission for documented (1) nonfat al myocardial infarction, (2) myocardial ischemia, (3) heart failure, (4) p eripheral vascular disease, (5) cerebrovascular accident and/or (6) end-sta ge renal disease. (C) 2000 by Excerpta Medica, Inc.