About: Challenges in the conduct of large simple trials of important generic questions in resource-poor settings: The CREATE and ECLA trial program evaluating GIK (glucose, insulin and potassium) and low-molecular-weight heparin in acute myocardial infarction

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About: Challenges in the conduct of large simple trials of important generic questions in resource-poor settings: The CREATE and ECLA trial program evaluating GIK (glucose, insulin and potassium) and low-molecular-weight heparin in acute myocardial infarction Goto Sponge NotDistinct Permalink

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Challenges in the conduct of large simple trials of important generic questions in resource-poor settings: The CREATE and ECLA trial program evaluating GIK (glucose, insulin and potassium) and low-molecular-weight heparin in acute myocardial infarction
Creator	Xie, Changchun Díaz, Rafael Khazmi, Khawar Liu, Lisheng Pais, Prem Paolasso, Ernesto Xavier, Denis Yusuf, Salim Zhu, Jun Mehta, Shamir Ahmed, Rashid
Source	Elsevier; Medline; PMC
abstract	Abstract 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 Clínicos 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.
has issue date	2004-12-31(xsd:dateTime)
bibo:doi	10.1016/j.ahj.2004.08.033
bibo:pmid	15632895
has license	els-covid
sha1sum (hex)	00d1165856c978d9b09bee5e0a1fbca063df6c4a
schema:url	https://doi.org/10.1016/j.ahj.2004.08.033
resource representing a document's title	Challenges in the conduct of large simple trials of important generic questions in resource-poor settings: The CREATE and ECLA trial program evaluating GIK (glucose, insulin and potassium) and low-molecular-weight heparin in acute myocardial infarction
has PubMed Central identifier	PMC7118878
has PubMed identifier	15632895
schema:publication	American Heart Journal
resource representing a document's body	covid:00d1165856c978d9b09bee5e0a1fbca063df6c4a#body_text
is schema:about of	named entity 'EVALUATING' named entity 'ECLA' named entity 'CHALLENGES' named entity 'promising' named entity 'program' named entity 'POOR' named entity 'RESOURCE' named entity 'MILLION' named entity 'LOW' named entity 'DUE TO' named entity 'COUNTRIES' named entity 'MIDDLE' named entity 'LARGE' named entity 'CONDUCT' named entity 'SIMPLE' named entity 'CARDIOVASCULAR DISEASES' named entity 'DEATHS' named entity 'PROGRAM' named entity 'GIK' named entity 'GENERIC' named entity 'IMPORTANT' named entity 'SETTINGS' named entity 'POTASSIUM' named entity 'CREATE' named entity 'LOW-MOLECULAR-WEIGHT HEPARIN' named entity 'EVERY YEAR' named entity 'OCCUR' named entity 'TREATMENTS' named entity 'EVALUATION' named entity 'INSULIN' named entity 'INCONCLUSIVE' named entity 'INCOME' named entity 'THERAPIES' named entity 'GLUCOSE' named entity 'ACUTE MYOCARDIAL INFARCTION' named entity 'AVAILABLE' named entity 'THESE' named entity 'COST' named entity 'APPEAR' named entity 'BACKGROUND' named entity 'INSULIN' named entity 'AMI' named entity 'INFUSION' named entity 'APPROXIMATELY' named entity '80%' named entity 'HALF' named entity 'LOW-MOLECULAR-WEIGHT HEPARIN' named entity 'ACUTE MYOCARDIAL INFARCTION' named entity 'TRIAL' named entity 'POTASSIUM' covid:arg/00d1165856c978d9b09bee5e0a1fbca063df6c4a named entity 'rigorous' named entity 'acute myocardial infarction' named entity 'AMI' named entity 'cardiovascular diseases' named entity 'low-molecular-weight heparin' named entity 'AMI' named entity 'middle-income' named entity 'potassium' named entity 'low-molecular-weight heparin' named entity 'potassium' named entity 'insulin' named entity 'all-cause' named entity '3.5' named entity 'randomization' named entity 'potassium' named entity 'coronary artery' named entity 'Bangalore' named entity 'heparin' named entity 'anti-platelet' named entity 'India'

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