A STUDY TO DETERMINE THE RESPONSE OF CORONARY ATHEROSCLEROSIS TO RAISING LOW HIGH-DENSITY-LIPOPROTEIN CHOLESTEROL WITH A FIBRIC-ACID DERIVATIVE IN MEN AFTER CORONARY-BYPASS SURGERY - THE RATIONALE, DESIGN, ANDBASE-LINE CHARACTERISTICS OF THE LOCAT STUDY

Several clinical trials have shown that reducing serum cholesterol lev els retards the progression of coronary atherosclerosis assessed by se rial angiography. By contrast, as yet no studies have addressed the im pact of increasing high density lipoprotein (HDL) cholesterol levels o n progression of coronary artery disease (CAD). As HDL cholesterol is inversely related to the risk of CAD, we hypothesize that an intervent ion that raises low HDL cholesterol concentrations may have a benefici al effect on the course of CAD. Lopid Coronary Angiography Trial (LOCA T) was designed to test this hypothesis. Three hundred and ninety-five men, aged less than or equal to 70 years, all of whom had previously undergone coronary bypass surgery, were randomly assigned to receive e ither slow release gemfibrozil, 1200 mg once daily, or a matching plac ebo for on average 2 1/2 years. The lipid inclusion criteria were HDL cholesterol concentration less than or equal to 1.1 mmol/L, low densit y lipoprotein (LDL) cholesterol less than or equal to 4.5 mmol/L, and serum triglyceride less than or equal to 4.0 mmol/L. Subjects were not accepted if they had manifest diabetes, body mass index >30 kg/m(2), uncontrolled hypertension, or if they were regular smokers. All random ized subjects underwent baseline coronary angiography, which will be r epeated at the end of the study. The angiograms will be analyzed using the Cardiovascular Measurement System, a validated computer-assisted image-analysis and quantitation package. The primary endpoints are the changes in the per-patient mean of 1) the average diameter of evaluab le native coronary segments, and 2) the minimal luminal diameter of ev aluable stenoses, and 3) the appearance of new lesions. Extensive Lipo protein and other metabolic studies and analyses of genetic polymorphi sms are carried out to study the determinants of CAD progression. At b aseline, the study subjects were 59.1 +/- 6.8 (mean +/- standard devia tion) years old, had a body mass index 26.4 +/- 2.2 kg/m(2), and serum triglyceride, serum cholesterol, HDL cholesterol, and LDL cholesterol concentrations 1.64 +/- 0.64, 5.17 +/- 0.64, 0.82 +/- 0.14, and 3.61 +/- 0.53 mmol/L, respectively. (C) M. Syvanne et al 1997.