DESIGN OF A PLACEBO-CONTROLLED CLINICAL-TRIAL OF LONG-ACTING DILTIAZEM AND ASPIRIN VERSUS ASPIRIN ALONE IN PATIENTS RECEIVING THROMBOLYSIS WITH A FIRST ACUTE MYOCARDIAL-INFARCTION

Several pharmacologic forms of adjunctive therapy, designed to enhance the efficacy of thrombolysis following acute myocardial infarction (A MI), are being explored. However, few studies have assessed the use of standard secondary prevention therapies (beta-blockers, angiotensin-c onverting enzyme inhibitors, magnesium, calcium antagonists, etc.) for antecedent thrombolysis. Although calcium antagonists have not been s hown to alter post-AMI mortality, diltiazem has been shown to reduce r ecurrent nonfatal infarction and myocardial ischemia following non-Q-w ave AMI. Because both non-Q-wave AMI and AMI treated with thrombolytic therapy result in early reperfusion and clinical manifestations of '' incomplete infarction'' (i.e., aborted transmural infarction), we hypo thesize that prophylactic administration of diltiazem to AMI patients who receive thrombolysis before other therapies might decrease ischemi c complications. We have initiated a multicenter, randomized, placebo- controlled, double-blind, parallel-group comparison of long acting dil tiazem 300 mg/day and aspirin 160 mg/day versus aspirin 160 mg/day alo ne in vp to 920 patients with an uncomplicated first AMI (no heart fai lure or left ventricular dysfunction) within 36 to 96 hours of receivi ng thrombolysis. Active enrollment is under way at 46 centers in the U nited Kingdom, Belgium, The Netherlands, and Denmark. This trial (know n as the incomplete INfarction Trial of European Research Collaborator s Evaluating Prognosis Post-Thrombolysis [diltiazem], or INTERCEPT) re presents the first long-term large-scale, prospective study of a calci um antagonist administered post-thrombolysis as adjunctive therapy to AMI patients in which the primary trial objective is to assess the eff ect of blinded therapy on the 6-month cumulative occurrence of a combi ned clinical end point (cardiac death, recurrent nonfatal AMI, and med ically refractory ischemia).