J. of Cardiovasc. Trans. Res. (2014) 7:112–125 DOI 10.1007/s12265-013-9532-6
Lessons Learned from Negative Clinical Trials Evaluating Antithrombotic Therapy for Ischemic Heart Disease Hyun-Jae Kang & Matthew T. Roe
Received: 4 October 2013 / Accepted: 12 December 2013 / Published online: 25 January 2014 # Springer Science+Business Media New York 2014
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.
Therefore, a review of the key, large-scale clinical trials of antithrombotic therapy for ischemic heart disease during the last decade that failed to achieve their primary efficacy endpoints can help to provide insights that may inform the conduct of future trials. Within this manuscript, we will review a number of recent, negative clinical trials of antithrombotic therapies for ischemic heart disease. We will discuss the implications of these trial results for contemporary clinical practice, considerations for balancing ischemic versus bleeding risks with antithrombotic therapies, and how these trial results may influence future studies of antithrombotic therapies.
Keywords Clinical trial . Antithrombotic therapy
The Superior Yield of the New Strategy of Enoxaparin, Revascularization, and Glycoprotein IIb/IIIa Inhibitors
During the last two decades, there have been remarkable improvements in antithrombotic therapy for the treatment of ischemic heart disease that have prompted significant changes to clinical practice guidelines for acute and chronic ischemic heart disease [1–3]. New antithrombotic therapies, that improved outcomes for patients with ischemic heart diseases in pivotal clinical trials [4–7], were included in clinical practice guidelines and changed clinical practices. Despite these advances, there have been more large-scale trials with antithrombotic therapies that have been negative or neutral. Nonetheless, valuable lessons can be learned from these negative clinical trials of antithrombotic therapy for ischemic heart diseases, especially contemporary studies recently performed. Associate Editor Dominick Angiolillo oversaw the review of this article H.
Lessons Learned from Negative Clinical Trials Evaluating Antithrombotic Therapy for Ischemic Heart Disease Hyun-Jae Kang & Matthew T. Roe
Received: 4 October 2013 / Accepted: 12 December 2013 / Published online: 25 January 2014 # Springer Science+Business Media New York 2014
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.
Therefore, a review of the key, large-scale clinical trials of antithrombotic therapy for ischemic heart disease during the last decade that failed to achieve their primary efficacy endpoints can help to provide insights that may inform the conduct of future trials. Within this manuscript, we will review a number of recent, negative clinical trials of antithrombotic therapies for ischemic heart disease. We will discuss the implications of these trial results for contemporary clinical practice, considerations for balancing ischemic versus bleeding risks with antithrombotic therapies, and how these trial results may influence future studies of antithrombotic therapies.
Keywords Clinical trial . Antithrombotic therapy
The Superior Yield of the New Strategy of Enoxaparin, Revascularization, and Glycoprotein IIb/IIIa Inhibitors
During the last two decades, there have been remarkable improvements in antithrombotic therapy for the treatment of ischemic heart disease that have prompted significant changes to clinical practice guidelines for acute and chronic ischemic heart disease [1–3]. New antithrombotic therapies, that improved outcomes for patients with ischemic heart diseases in pivotal clinical trials [4–7], were included in clinical practice guidelines and changed clinical practices. Despite these advances, there have been more large-scale trials with antithrombotic therapies that have been negative or neutral. Nonetheless, valuable lessons can be learned from these negative clinical trials of antithrombotic therapy for ischemic heart diseases, especially contemporary studies recently performed. Associate Editor Dominick Angiolillo oversaw the review of this article H.
