Design features of a controlled clinical trial to assess the effect of a calcium entry blocker upon the progression of coronary artery disease.

This report presents the design and methodological features of a double-blind, randomized, placebo-controlled, trial in 383 patients with coronary artery disease. The study's principal objective is to determine whether chronic treatment with a calcium entry blocker can retard the progression of coronary artery disease. The study population consists of patients with coronary artery disease and a baseline coronary arteriogram that qualifies them as being at high risk for disease progression. After satisfying all entry criteria, patients were randomized to receive either the calcium entry blocker nicardipine or placebo. All indicated concomitant medications except calcium entry blockers are permitted. Patients are being followed clinically for 24 months before undergoing a second coronary arteriogram. The effect of the treatments on a variety of clinical and angiographic parameters will be determined.

RCT Entities:   Population Interventions Outcomes