Department of Medicine， McMaster University， and Population Health Research Institute， Hamilton General Hospital， Hamilton， Canada. yusufs@mcmaster.ca
BACKGROUND: Approximately 15.5 million deaths from cardiovascular diseases occur every year. About half are due to acute myocardial infarction (AMI)， and 80% occur in low- and middle-income countries. Therefore， low-cost therapies would be invaluable. Although glucose-insulin-potassium (GIK) infusion and low-molecular-weight heparin (LMWH) appear to be promising in AMI， the available trials are inconclusive and these treatments require rigorous evaluation.
METHODS: The Clinical Trial of Reviparin and Metabolic Modulation in Acute Myocardial Infarction Treatment and Evaluation-Estudios Clinicos Latino America (CREATE-ECLA) study is a randomized controlled trial in ST-elevation AMI patients evaluating a 24-hour infusion of Glucose-Insulin-Potassium (GIK) intravenous vs usual care (control) on 30-day mortality in 20，000 patients from 21 countries. Patients from India and China (n = 15，000) are also randomized using a factorial design to receive low-molecular-weight heparin (Reviparin) or placebo injection twice daily for 7 days to assess the impact on the composite outcomes of death， reinfarction or stroke (first co-primary outcome) or the composite + refractory ischemia (second co-primary outcome).
RESULTS: Twenty thousand two hundred and one (20，201) GIK/control patients and 15，570 Reviparin/placebo patients have been included， with results expected in November 2004.
CONCLUSIONS: The CREATE-ECLA trial will provide definitive answers to the role of 2 practical， promising and low-cost therapies， LMWH and GIK， in AMI patients. If effective， these therapies could be used in small medical centers in low- and middle- income countries. The experiences in this trial indicate that large trials of important questions can be successfully conducted in resource-poor settings， by academic groups without industry involvement.