IMP roved R eduction of O utcomes: V ytorin E fficacy I nternational T rial A Multicenter, Double - Blind, Randomized Study to Establish the Clinical Benefit and Safety of Vytorin (Ezetimibe/Simvastatin Tablet) vs Simvastatin Monotherapy in High - Risk Subjects Presenting With Acute Coronary Syndrome
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IMProved Reduction of Outcomes: Vytorin Efficacy International Trial
A Multicenter, Double-Blind, Randomized Study to
Establish the Clinical Benefit and Safety of Vytorin
(Ezetimibe/Simvastatin Tablet) vs Simvastatin
Monotherapy in High-Risk Subjects Presenting
With Acute Coronary Syndrome
Trial Leadership
Study Chairmen: Eugene Braunwald and Robert Califf
TIMI Study Group: Christopher Cannon Robert Giugliano
Amy McCagg Christina Pelland
Sabina Murphy Erin Bohula May
DCRI: Michael Blazing Craig Reist
Jennifer White Yuliya Lokhnygina
Curtis Campbell Cathy Martz
Merck: Thomas Musliner Andrew Tershakovec
Ann Kilian Rona Harmelin-Kadouri
Paul DeLucca Steve Bird
DSMB Chair: Scott Grundy
CEC Chair: Stephen Wiviott
National Lead Investigators and Steering Committee (1158 sites, 39 Countries)
Enrique Gurfinkel¹Argentina (331)
Philip AylwardAndrew Tonkin*Australia (116)
Gerald MaurerGermany (935)
Frans Van de WerfBelgium (249)
Jose C. NicolauBrazil (423)
Pierre TherouxPaul Armstrong*Jacques Genest*Canada (1106)
Ramon CobalanChile (152)
Daniel IsazaColombia (568)
Jindrich SpinarCzech Rep (371)
Peer Grande²Denmark (576)
Juri VoitkEstonia (10)
Antero KesaniemiFinland (341)
Jean-Pierre BassandMichel Franier*France (268)
Harald DariusGermany (935)
Matayas KeltaiHungary (116)
Atul MathurSanjay MittalKrishna ReddyIndia (259)
Basil LewisIsrael (589)
Gaetano DeFerrariItaly (593)
Ton Oude OphuisJ. Wouter Jukema*Netherlands (1191)
Harvey WhiteNew Zealand (164)
Terje PedersenNorway (295)
Frank BrittoPeru (66)
Witold RuzylloPoland (589)
Manuel CarragetaPortugal (102)
Ki-Bae SeungS. Korea (118)
Singapore (75), Malaysia (59), Hong Kong (58) Ecuador (45), Taiwan (46)
*Steering Comm Member, ¹ Deceased, ² 2005–2013
Tibor DurisSlovakia (121)
Anthony DalbyS. Africa (186)
Jose Lopez-SendonSpain (551)
Mikael DellborgSweden (480)
Francois MachSwitzerland (263)
Sema GuneriTurkey (50)
Alexander ParkhomenkoUkraine (159)
Adrian BradyUnited Kingdom (318)
Michael BlazingChristopher CannonChristie Ballantyne*James de Lemos*Neal Kleiman*Darren McGuire*United States (5869)
Background: Cholesterol Lowering
➢ Lowering LDL cholesterol (LDL-C) has been a mainstay
of cardiovascular prevention
➢ Evidence mostly from statin trials which show reduction
in morbidity and mortality
– High-dose statins further reduce non-fatal CV events
➢ To date, no lipid-modifying therapy added to statins has
been demonstrated to provide a clinical benefit
– Fibrates, niacin, CETP inhibitors
➢ Recent ACC/AHA Guidelines have emphasized use of
statin therapy
➢ Despite current therapies, patients remain at high risk