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Lessons Learned from Negative Clinical Trials Evaluating Antithrombotic Therapy for Ischemic Heart Disease

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Abstract

The clinical trials that failed to demonstrate significant efficacy may not result in development of new therapy but contribute to better understanding of antithrombotic therapy for ischemic heart disease. Negative trials provide important messages about how to interpret and understand the results of clinical trials and apply these results to clinical practices. Although every aspect of clinical trials may influence the outcomes of trials and interpretation of their results, selection of study subjects, endpoints, and measuring risk/benefit are crucial to success of clinical trial. We will review the recent key negative trials on antithrombotic therapy for ischemic heart disease and discuss about their results and implications. The challenge in the future for the development of antithrombotic therapies is to leverage these “lessons learned” from negative clinical trials to improve the design, conduct, and interpretation of future randomized clinical trials.

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Conflict of interest

HJK—nothing to declare. MTR—research funding: Eli Lilly, Revalesio, Sanofi-Aventis, American College of Cardiology, American Heart Association, Familial Hyperlipidemia Foundation; consulting or honoraria: Eli Lilly, Astra Zeneca, Sanofi-Aventis, Janssen Pharmaceuticals, Merck, Regeneron, and Daiichi-Sankyo. All conflicts of interest are listed at www.dcri.org.

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  1. Duke Clinical Research Institute, Durham, NC, USA

    Hyun-Jae Kang & Matthew T. Roe

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  1. Hyun-Jae Kang
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  2. Matthew T. Roe
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Correspondence to Matthew T. Roe.

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Associate Editor Dominick Angiolillo oversaw the review of this article

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Kang, HJ., Roe, M.T. Lessons Learned from Negative Clinical Trials Evaluating Antithrombotic Therapy for Ischemic Heart Disease. J. of Cardiovasc. Trans. Res. 7, 112–125 (2014). https://doi.org/10.1007/s12265-013-9532-6

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  • DOI: https://doi.org/10.1007/s12265-013-9532-6

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