Design and recruitment in the United States of a multicenter quantitative angiographic trial of pravastatin to limit atherosclerosis in the coronary arteries (PLAC I)

• Published in: The American journal of cardiology Vol. 72; no. 1; pp. 31 - 35
• Main Authors: Pitt, Bertram, Ellis, Stephen G., Mancini, G.B.John, Rosman, Howard S., McGovern, Mark E., The PLAC I Investigators
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01-07-1993; Elsevier; Elsevier Limited
• Subjects: Adult; Aged; Biological and medical sciences; Cardiovascular disease; Cholesterol; Clinical Protocols; Coronary Artery Disease - drug therapy; Enzymes; Female; General and cellular metabolism. Vitamins; Humans; Male; Medical research; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Pravastatin - therapeutic use; Research Design; Human; Radiodiagnosis; Enzyme; Coronary artery; Enzyme inhibitor; Cardiovascular disease; Exploration; Angiocardiography; Vascular disease; Chemotherapy; Treatment; Atherosclerosis; Hydroxymethylglutaryl-CoA reductase; Therapeutic protocol; Antilipemic agent
• ISSN: 0002-9149; 1879-1913
• DOI: 10.1016/0002-9149(93)90214-W

The present study was designed to test the effect of pravastatin, a new, 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor, on the progression of coronary artery disease in patients with moderate hypercholesterolemia. Angiographic entry criteria included the presence of ≥1 stenosis ≥50% in a major epicardial coronary artery, and certification of film quality through the core angiography laboratory. Patients qualified for randomization if after diet stabilization their low density lipoprotein cholesterol concentrations were ≥130 and < 190 mg/dl, and triglycerides were ≤ 350 mg/dl. Pravastatin (40 mg) or placebo is administered once daily at bedtime. Arteriography will be repeated at the end of 3 years of treatment. The primary end point of the study is the change in absolute mean coronary artery diameter. During a 30-month recruitment period, 44,145 patients were screened, and 408 were randomized. The most frequent reason for excluding patients during the screening and dietary lead-in periods was a low serum cholesterol level. A large proportion of patients with documented coronary artery disease have cholesterol concentrations that are considered to be normal or only modestly increased. Adherence to strict standards of quality control for digital analysis of angiograms ensures that baseline angiograms can be interpreted at the end of 3-year follow-up.