The future of clinical trials in secondary prevention after acute coronary syndromes

Randomized clinical trials (RCTs) are the gold standard for building evidence. However, the strength of evidence in cardiovascular disease guidelines is not keeping pace with the number of emerging recommendations,1 perhaps reflecting the growing difficulties in developing adequately powered RCTs. In the context of secondary prevention after acute coronary syndromes (ACS), the increase in sample size needed to establish benefit, the rising costs, and the growing complexity of the regulatory environment and study logistics are challenging the development of new therapies. In response to these concerns, the European Society of Cardiology (ESC) convened an ad hoc meeting in May 2009. This paper summarizes the discussions and offers suggestions for improvement ( Table 1 ), which may complement previous proposals.2 [Note: the ideas presented are those of the individual participants (listed in the Appendix) and do not reflect the ideas of the participating bodies]. View this table: Table 1 Strategies to improve research on secondary prevention after acute coronary syndromes In spite of major advances, our understanding of the pathophysiology of coronary atherosclerosis progression and triggers of recurrent thrombotic events after ACS remains limited. To enhance therapeutic development, a clearer picture of coronary atherothrombosis is required. For that, large collaborative consortia between Pharma and acadaemia focused on pathophysiology, genetic epidemiology, new biomarkers, and other intermediate measurements, as well as clinical research on traditional outcomes are needed to better understand the natural history of coronary artery disease. The identification of new pathways and therapeutic targets, as well as the genetic, phenotypic, or behavioural causes underlying the wide individual variations in responses to therapies, particularly antithrombotic treatments should be prioritized. Traditional and new ways of research will be essential to achieve these objectives ( Table 1 ).3 Better ways are also needed to identify patients at high risk for coronary or other vascular recurrences as well as the …