Literature DB >> 24464592

Lessons learned from negative clinical trials evaluating antithrombotic therapy for ischemic heart disease.

Hyun-Jae Kang1, Matthew T Roe.   

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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Year:  2014        PMID: 24464592     DOI: 10.1007/s12265-013-9532-6

Source DB:  PubMed          Journal:  J Cardiovasc Transl Res        ISSN: 1937-5387            Impact factor:   4.132


  44 in total

1.  Rivaroxaban in patients with a recent acute coronary syndrome.

Authors:  Jessica L Mega; Eugene Braunwald; Stephen D Wiviott; Jean-Pierre Bassand; Deepak L Bhatt; Christoph Bode; Paul Burton; Marc Cohen; Nancy Cook-Bruns; Keith A A Fox; Shinya Goto; Sabina A Murphy; Alexei N Plotnikov; David Schneider; Xiang Sun; Freek W A Verheugt; C Michael Gibson
Journal:  N Engl J Med       Date:  2011-11-13       Impact factor: 91.245

2.  A new era in secondary prevention after acute coronary syndrome.

Authors:  Matthew T Roe; E Magnus Ohman
Journal:  N Engl J Med       Date:  2011-11-13       Impact factor: 91.245

3.  Pretreatment with prasugrel in non-ST-segment elevation acute coronary syndromes.

Authors:  Gilles Montalescot; Leonardo Bolognese; Dariusz Dudek; Patrick Goldstein; Christian Hamm; Jean-Francois Tanguay; Jurrien M ten Berg; Debra L Miller; Timothy M Costigan; Jochen Goedicke; Johanne Silvain; Paolo Angioli; Jacek Legutko; Margit Niethammer; Zuzana Motovska; Joseph A Jakubowski; Guillaume Cayla; Luigi Oltrona Visconti; Eric Vicaut; Petr Widimsky
Journal:  N Engl J Med       Date:  2013-09-01       Impact factor: 91.245

4.  ACC/AHA 2007 guidelines for the management of patients with unstable angina/non ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction): developed in collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons: endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine.

Authors:  Jeffrey L Anderson; Cynthia D Adams; Elliott M Antman; Charles R Bridges; Robert M Califf; Donald E Casey; William E Chavey; Francis M Fesmire; Judith S Hochman; Thomas N Levin; A Michael Lincoff; Eric D Peterson; Pierre Theroux; Nanette Kass Wenger; R Scott Wright; Sidney C Smith; Alice K Jacobs; Jonathan L Halperin; Sharon A Hunt; Harlan M Krumholz; Frederick G Kushner; Bruce W Lytle; Rick Nishimura; Joseph P Ornato; Richard L Page; Barbara Riegel
Journal:  Circulation       Date:  2007-08-06       Impact factor: 29.690

5.  Perceived risk of ischemic and bleeding events in acute coronary syndromes.

Authors:  Derek P Chew; Ge Junbo; William Parsonage; Prafulla Kerkar; Vitaly A Sulimov; Matthew Horsfall; Sue Mattchoss
Journal:  Circ Cardiovasc Qual Outcomes       Date:  2013-05-07

6.  Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium.

Authors:  Roxana Mehran; Sunil V Rao; Deepak L Bhatt; C Michael Gibson; Adriano Caixeta; John Eikelboom; Sanjay Kaul; Stephen D Wiviott; Venu Menon; Eugenia Nikolsky; Victor Serebruany; Marco Valgimigli; Pascal Vranckx; David Taggart; Joseph F Sabik; Donald E Cutlip; Mitchell W Krucoff; E Magnus Ohman; Philippe Gabriel Steg; Harvey White
Journal:  Circulation       Date:  2011-06-14       Impact factor: 29.690

7.  Effect of platelet inhibition with cangrelor during PCI on ischemic events.

Authors:  Deepak L Bhatt; Gregg W Stone; Kenneth W Mahaffey; C Michael Gibson; P Gabriel Steg; Christian W Hamm; Matthew J Price; Sergio Leonardi; Dianne Gallup; Ezio Bramucci; Peter W Radke; Petr Widimský; Frantisek Tousek; Jeffrey Tauth; Douglas Spriggs; Brent T McLaurin; Dominick J Angiolillo; Philippe Généreux; Tiepu Liu; Jayne Prats; Meredith Todd; Simona Skerjanec; Harvey D White; Robert A Harrington
Journal:  N Engl J Med       Date:  2013-03-10       Impact factor: 91.245

8.  Vorapaxar for secondary prevention of thrombotic events for patients with previous myocardial infarction: a prespecified subgroup analysis of the TRA 2°P-TIMI 50 trial.

Authors:  Benjamin M Scirica; Marc P Bonaca; Eugene Braunwald; Gaetano M De Ferrari; Daniel Isaza; Basil S Lewis; Felix Mehrhof; Piera A Merlini; Sabina A Murphy; Marc S Sabatine; Michal Tendera; Frans Van de Werf; Robert Wilcox; David A Morrow
Journal:  Lancet       Date:  2012-08-26       Impact factor: 79.321

9.  Intravenous platelet blockade with cangrelor during PCI.

Authors:  Deepak L Bhatt; A Michael Lincoff; C Michael Gibson; Gregg W Stone; Steven McNulty; Gilles Montalescot; Neal S Kleiman; Shaun G Goodman; Harvey D White; Kenneth W Mahaffey; Charles V Pollack; Steven V Manoukian; Petr Widimsky; Derek P Chew; Fernando Cura; Ivan Manukov; Frantisek Tousek; M Zubair Jafar; Jaspal Arneja; Simona Skerjanec; Robert A Harrington
Journal:  N Engl J Med       Date:  2009-12-10       Impact factor: 91.245

10.  Platelet inhibition with cangrelor in patients undergoing PCI.

Authors:  Robert A Harrington; Gregg W Stone; Steven McNulty; Harvey D White; A Michael Lincoff; C Michael Gibson; Charles V Pollack; Gilles Montalescot; Kenneth W Mahaffey; Neal S Kleiman; Shaun G Goodman; Maged Amine; Dominick J Angiolillo; Richard C Becker; Derek P Chew; William J French; Franz Leisch; Keyur H Parikh; Simona Skerjanec; Deepak L Bhatt
Journal:  N Engl J Med       Date:  2009-12-10       Impact factor: 91.245

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