BACKGROUND: Acute myocardial infarction (MI) remains a leading cause of death despite advances in pharmacologic and percutaneous therapies. Animal models of ischemia/reperfusion have demonstrated that single-dose erythropoietin may reduce infarct size, decrease apoptosis, and increase neovascularization, possibly through mobilization of endothelial progenitor cells. STUDY DESIGN: REVEAL is a randomized, double-blind, placebo-controlled, multicenter trial evaluating the effects of epoetin α on infarct size and left ventricular remodeling in patients with large MIs. The trial comprises a dose-escalation safety phase and a single-dose efficacy phase using the highest acceptable epoetin α dose up to 60,000 IU. Up to 250 ST-segment elevation myocardial infarction patients undergoing primary or rescue percutaneous coronary intervention will be randomized to intravenous epoetin α or placebo within 4 hours of successful reperfusion. The primary study end point is infarct size expressed as a percentage of left ventricular mass, as measured by cardiac magnetic resonance imaging 2 to 6 days post study medication administration. Secondary end points will assess changes in endothelial progenitor cell numbers and changes in indices of ventricular remodeling. CONCLUSION: The REVEAL trial will evaluate the safety and efficacy of the highest tolerated single dose of epoetin α in patients who have undergone successful rescue or primary percutaneous coronary intervention for acute ST-segment elevation myocardial infarction.
RCT Entities:
BACKGROUND:Acute myocardial infarction (MI) remains a leading cause of death despite advances in pharmacologic and percutaneous therapies. Animal models of ischemia/reperfusion have demonstrated that single-dose erythropoietin may reduce infarct size, decrease apoptosis, and increase neovascularization, possibly through mobilization of endothelial progenitor cells. STUDY DESIGN: REVEAL is a randomized, double-blind, placebo-controlled, multicenter trial evaluating the effects of epoetin α on infarct size and left ventricular remodeling in patients with large MIs. The trial comprises a dose-escalation safety phase and a single-dose efficacy phase using the highest acceptable epoetin α dose up to 60,000 IU. Up to 250 ST-segment elevation myocardial infarctionpatients undergoing primary or rescue percutaneous coronary intervention will be randomized to intravenous epoetin α or placebo within 4 hours of successful reperfusion. The primary study end point is infarct size expressed as a percentage of left ventricular mass, as measured by cardiac magnetic resonance imaging 2 to 6 days post study medication administration. Secondary end points will assess changes in endothelial progenitor cell numbers and changes in indices of ventricular remodeling. CONCLUSION: The REVEAL trial will evaluate the safety and efficacy of the highest tolerated single dose of epoetin α in patients who have undergone successful rescue or primary percutaneous coronary intervention for acute ST-segment elevation myocardial infarction.
Authors: K W Baran; M Nguyen; G R McKendall; C T Lambrew; G Dykstra; S T Palmeri; R J Gibbons; S Borzak; B E Sobel; S G Gourlay; A C Rundle; C M Gibson; H V Barron Journal: Circulation Date: 2001-12-04 Impact factor: 29.690
Authors: Hannelore Ehrenreich; Martin Hasselblatt; Christoph Dembowski; Lukas Cepek; Piotr Lewczuk; Michael Stiefel; Hans-Heino Rustenbeck; Norbert Breiter; Sonja Jacob; Friederike Knerlich; Matthias Bohn; Wolfgang Poser; Eckart Rüther; Michael Kochen; Olaf Gefeller; Christoph Gleiter; Thomas C Wessel; Marc De Ryck; Loretta Itri; Hilmar Prange; Anthony Cerami; Michael Brines; Anna-Leena Sirén Journal: Mol Med Date: 2002-08 Impact factor: 6.354
Authors: David P Faxon; Raymond J Gibbons; Nicolas A F Chronos; Paul A Gurbel; Florence Sheehan Journal: J Am Coll Cardiol Date: 2002-10-02 Impact factor: 24.094
Authors: Christopher Heeschen; Alexandra Aicher; Ralf Lehmann; Stephan Fichtlscherer; Mariuca Vasa; Carmen Urbich; Christiane Mildner-Rihm; Hans Martin; Andreas M Zeiher; Stefanie Dimmeler Journal: Blood Date: 2003-04-17 Impact factor: 22.113
Authors: Laura Calvillo; Roberto Latini; Jan Kajstura; Annarosa Leri; Piero Anversa; Pietro Ghezzi; Monica Salio; Anthony Cerami; Michael Brines Journal: Proc Natl Acad Sci U S A Date: 2003-03-27 Impact factor: 11.205
Authors: A A Kocher; M D Schuster; M J Szabolcs; S Takuma; D Burkhoff; J Wang; S Homma; N M Edwards; S Itescu Journal: Nat Med Date: 2001-04 Impact factor: 53.440
Authors: Donna M Mancini; Stuart D Katz; Chim C Lang; John LaManca; Alhakam Hudaihed; Ana-Silvia Androne Journal: Circulation Date: 2003-01-21 Impact factor: 29.690
Authors: Rosemeire M Kanashiro-Takeuchi; Lauro M Takeuchi; Konstantinos Hatzistergos; Henry Quevedo; Sarah M Selem; Adriana V Treuer; Courtney Premer; Wayne Balkan; Irene Margitich; Yun Song; Qinghua Hu; Joshua M Hare Journal: Clin Transl Sci Date: 2011-06 Impact factor: 4.689
Authors: Samer S Najjar; Sunil V Rao; Chiara Melloni; Subha V Raman; Thomas J Povsic; Laura Melton; Gregory W Barsness; Kristi Prather; John F Heitner; Rakhi Kilaru; Luis Gruberg; Vic Hasselblad; Adam B Greenbaum; Manesh Patel; Raymond J Kim; Mark Talan; Luigi Ferrucci; Dan L Longo; Edward G Lakatta; Robert A Harrington Journal: JAMA Date: 2011-05-11 Impact factor: 56.272
Authors: Thomas J Povsic; Samer S Najjar; Kristi Prather; Jiying Zhou; Stacie D Adams; Katherine L Zavodni; Francine Kelly; Laura G Melton; Vic Hasselblad; John F Heitner; Subha V Raman; Gregory W Barsness; Manesh R Patel; Raymond J Kim; Edward G Lakatta; Robert A Harrington; Sunil V Rao Journal: J Thromb Thrombolysis Date: 2013-11 Impact factor: 2.300