ORAL CAPTOPRIL VERSUS PLACEBO AMONG 14,962 PATIENTS WITH SUSPECTED ACUTE MYOCARDIAL-INFARCTION - A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL-TRIAL

Objective To assess the efficacy of captopril on mortality and morbidi ty after acute myocardial infarction (AMI). Methods A total of 14 962 patients entering 650 hospitals from 30 provinces and autonomous regio ns of China up to 36 hours (mean 16. 6 +/- 10. 2 hours) after the onse t of suspected acute myocardial infarction (MI) with no clear contrain dications or indications to the study treatments (in particular, no pe rsistent hypotension or hypovolemia due to long-term use of large dose of diuretics) were randomized to use either 4 weeks of oral captopril (6. 25 mg initial dose, 12. 5 mg 2 hours later, and then 12. 5 mg thr ee times daily) or matching placebo. Results Captopril was associated with a non-significant reduction in 4-week mortality (9. 12% vs 9. 74% ; P = 0. 20); but incidence of heart failure was significantly reduced among captopril-group (17. 0% vs 18. 7%; P = 0. 01). The combined end point (death + heart failure) was 1680 (21. 5%) in captopril group an d 1733 (23. 1%) in placebo group (P = 0. 02). Anterior wall infarction of captopril treated group was found to have lower mortality (8. 6% v s 10. 2%, P = 0. 02). Captopril treated group with a heart rate (HR) g reater than or equal to 60/min at entry showed significantly lower mor tality than placebo group (9. 2% vs 10. 7%; P = 0. 01). There was a si gnificant excess of hypotension, mostly after the start of treatment, but no evidence of any adverse effect on early mortality. Conclusions The angiotensin converting enzyme inhibitors (CEI) therapy started ear ly in acute MI prevents about 6 deaths per 1000 treated, and about 15 deaths due to heart failure per 1000 in the 1st 4 weeks with greater b enefits. In anterior myocardial infarction group it prevents 16 deaths per 1000 with nearly no benefit for the inferior infarction group. Du e to the parasympathetic mimic effect, CEI should be used carefully in inferior infarction patients especially when HR is slow or heart bloc k and hypotension are present.