DESIGN OF A RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER TRIAL ON THE LONG-TERM EFFECTS OF INTERMITTENT TRANSDERMAL NITROGLYCERIN ON LEFT-VENTRICULAR REMODELING AFTER ACUTE MYOCARDIAL-INFARCTION

Nitrates are widely used in the treatment of patients with ischemic he art disease and in those with angina following acute myocardial infarc tion, Short-term studies indicate that the administration of nitrates may prevent left ventricular (LV) dilation and infarct expansion, Anim al models suggest that prolonged nitroglycerin use after infarction ma y limit LV remodeling similar to that observed with angiotensin-conver ting enzyme inhibitors, However, to date there have been no trials eva luating the effects of nitrates on LV volumes in patients surviving ac ute myocordial infarction, We therefore performed a randomized double- blind, placebo-controlled trial designed to investigate the long-term (6 month) efficacy of intermittent transdermal nitroglycerin patches o n LV remodeling in 291 survivors of acute myocardial infarction, Patie nts were randomized to receive either placebo or a nitroglycerin patch that delivered 0.4, 0.8, or 1.6 mg/hour, Gated radionuclide angiograp hy was used to assess serial changes in LV ejection and cardiac volume s. The baseline characteristics of the study population were similar i n all 4 treatment groups, The study protocol and the main design-relat ed issues are described, (C) 1998 by Excerpta Medica, Inc.