American heart journal
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American heart journal · Aug 2004
Randomized Controlled Trial Clinical TrialClopidogrel added to aspirin versus aspirin alone in secondary prevention and high-risk primary prevention: rationale and design of the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance (CHARISMA) trial.
Clopidogrel is a more potent antiplatelet agent than aspirin, resulting in greater clinical efficacy in patients with atherothrombotic disease. Furthermore, the combination of clopidogrel plus aspirin has been demonstrated to be superior to aspirin alone in the treatment of patients with acute coronary syndromes and after coronary stenting. Whether dual antiplatelet therapy is superior to aspirin monotherapy for high-risk primary prevention and secondary prevention is unknown. ⋯ This large-scale trial of patients at high risk for atherothrombotic events will allow determination of the value of a strategy of adding clopidogrel to the current standard of care, including low-dose aspirin, for a wide spectrum of patients with atherothrombosis.
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American heart journal · Aug 2004
Too little aspirin for secondary prevention after acute myocardial infarction in patients at high risk for cardiovascular events: Results from the MITRA study.
A meta-analysis of randomized trials has shown a significant reduction of mortality rate in patients receiving aspirin for secondary prevention after acute myocardial infarction (AMI). However, a significant number of patients do not receive aspirin after AMI. Little is known about why aspirin is withheld or the long-term outcome of these patients today. ⋯ Ten percent of patients who sustained an AMI did not receive aspirin at the time of hospital discharge. Most of these patients were at high risk for cardiovascular events. Withheld aspirin was significantly associated with higher mortality rate during follow up.
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American heart journal · Aug 2004
Historical ArticleParticipation versus education: the GISSI story and beyond.
Approximately 20 years ago, the Italian cardiology community realized the scientific importance and the potential impact on clinical practice of the new concept of evidence-based medicine and launched (without funds) a national megatrial, the Gruppo Italiano por lo Studio della Streptochinasi nell'Infarto Miocardico (GISSI) study. In the following 20 years, 4 GISSI trials have been carried out, and a fifth is underway. The conceptual process that followed this experience shaped the role of the medico-scientific society that sponsored these trials as an active player in research, with the public health as the common target. ⋯ Accordingly, further studies were undertaken dealing with clinical epidemiology, observational outcome research introduced complementarily to develop lines of clinical investigation along 2 mainstreams: ischemic heart disease and heart failure. The original decision to directly sponsor countrywide research projects in critical and relevant areas of care had broader implications not only for the role of scientific societies, but more generally for the nurture of independent research, which is today widely recognized to be at risk. The articulation among experimental, observational, and evaluative protocols in which all caring physicians are allowed to be producers and authors and not simply users of knowledge can favor a cultural continuity that minimizes the risk of parallelisms and gaps between research and care.