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Am Heart J. 2009 Dec;158(6):896-901.e3. doi: 10.1016/j.ahj.2009.09.017.

Rationale and design of the dal-OUTCOMES trial: efficacy and safety of dalcetrapib in patients with recent acute coronary syndrome.

Collaborators (908)

Alvarez C, Alvarez M, Berli M, Bono J, Botto F, Labarta GB, Caccavo A, Caime G, Cartasegna L, Caruso O, Chekherdemian S, Covelli G, Cuneo C, Dran R, Fernandez AA, Fuselli J, Gadaleta F, Garrido M, Giacomi G, Hasbani E, Hominal M, Iglesias RM, Litvak BM, Llanos J, Luciardi H, Macin S, Mackinnon I, Manuale O, Muntaner J, Pelagagge JM, Piskorz D, Pomposiello JC, Porcile R, Sanchez AS, Santos D, Schygiel PO, Stisman DJ, Vico ML, Amerena J, Ardill J, Aroney C, Challa P, Colquhoun D, Garrahy P, Kritharides L, Lee A, New G, Purnell P, Tan R, Thompson P, van Gaal W, Waites J, Ziffer R, Drexel H, Gyongyosi M, Pieske B, Schuchlenz H, Siostrzonek P, Beauloye C, De Raedt H, De Wolf L, Leone A, Missault L, Stammen F, Vrolix M, Saad JA, Abrantes JA, Ardito WR, da Cost FA, Bodanese LC, Botelho R, Braile M, de Albuquerque DC, Sousa AC, Neto JD, dos Santos Filho R, Saporito WF, Feitosa A, Figueiredo G, Fonseca FA, Gomes M, Haddad A, Leaes PE, Maia L, Manenti E, Mendes D, Michalaros Y, Moraes JB Jr, Motta M, Paiva MS, Pastore CA, Dutra OP, Precoma D, Ramos R, Rossi P, Silva D Jr, Souza W, Teixeira M, Zago A, Abramson B, Baird M, Bedard JP, Bergeron J, Berlingieri J, Bernstein V, Bhargava R, Bose S, Bourgeois R, Chehayeb R, Constance C, Diaz A, Dion D, Ducas J, Fadlallah H, Fay D, Gagne C, Gosselin G, Gupta M, Hess A, Houde G, Hui W, Huynh T, Johnston J, Klinke P, Kornder J, Kouz S, Labonte R, Lai C, Lai K, Lainesse A, Lalani A, Lasko B, Lavoie JP, Leader R, LePage S, Lonn E, Ma P, Mansour S, Maranda C, Mymin D, Nawaz S, Nigro F, O'Keefe D, Pandey A, Pesant Y, Pouliot J, Prabhakar M, Ramjattan B, Rebane T, Rodes-Cabau J, Roy A, Rupka D, Sabbah E, Savard D, Schampaert E, Senaratne M, St-Amour E, Sussex B, Tardif JC, Title L, Vizel S, Bai F, Chao S, Chen J, Chen J, Chen Y, Fu G, Ge J, Hao Y, Hong X, Hu D, Hu T, Huang Y, Jiang X, Ke Y, Li H, Li J, Li Z, Lu Q, Qu P, Su H, Sun Y, Wang J, Wang M, Wei M, Wu Z, Xu B, Yang K, Yang X, Yang X, Yang Y, Yu B, Yuan Z, Zhang H, Zhao F, Zhou S, Ballek L, Bufka V, Cermak O, Coufal Z, Ferkl R, Groch L, Hornacek I, Hubac J, Jandik J, Jelinek P, Kaislerova M, Kotik I, Monhart Z, Naplava R, Ostadal P, Ramik C, Reichert P, Sabl P, Simek S, Skvarilova M, Stasek J, Vodnansky P, Brønnum-Schou J, Egstrup K, Jensen G, Klarlund K, Launbjerg J, May O, Nyvad O, Skagen K, Torp-Pedersen C, Tuxen C, Koskela E, Niskanen L, Nyman K, Agraou B, Aleil B, Aliot E, Asseman P, Bareiss P, Bonnet JL, Cattan S, Cohen A, Coisne D, Coste P, Cottin Y, D'Houdain F, Decoulx E, Demarcq JM, Dibie A, Furber A, Galinier M, Henry P, Katz O, Kirkorian G, Lafont A, Probst V, Steg G, Anker S, Baar M, Brachmann J, Braun P, Buerke M, Franz N, Franz W, Genth-Zotz S, Guelker H, Hanefeld C, Haude M, Hauf G, Heuer H, Hoffmann S, Horacek T, Jacob S, Kadel C, Kamke W, Katus H, Koenig W, Kreuzer J, Laufs U, Mueller-Wieland D, Philipp S, Richardt G, Schoeller R, Stellbrink C, Sueselbeck T, Voehringer HF, Voeller H, vom Dahl H, Werner G, Winkelmann B, Worth H, Barsi B, Csikász J, Edes I, Forster T, Horvath I, Janosi A, Keltai M, Kerekes C, Kis E, Kovacs Z, Laszlo Z, Lupkovics G, Mezofi M, Nagy A, Regos L, Sereg M, Toth K, Vértes A, Zámolyi K, Crean P, Foley D, Sugrue D, Aronson D, Atar S, Dicker D, Francis A, Halkin A, Hasin Y, Hayek T, Klainman E, Klutstein M, Kobal S, Kracoff O, Lahav M, Leitersdorf E, Lewis B, Lotan C, Mosseri M, Rauchfleisch S, Shechter M, Shochat M, Solodky A, Turgeman Y, Vered Z, Weiss A, Zeltser D, Benassi A, Bernabò P, Bernardi D, Binetti G, Boccanelli A, Bramucci E, Carbonieri E, Caso P, Catapano O, Cernigliaro C, Chiariello M, De Caterina R, Golino P, Musumeci G, Olivari Z, Rossi M, Salvioni A, Zerboni SC, Alings AM, Basart DC, Borkern MJ, Bronzwaer PN, Bruning TA, Cornel JH, Doevendans PA, Freericks MP, Hamer BJ, Hamraoui K, Herrman JP, Hoedemaker G, Holwerda NJ, Jukema JW, Klomps HC, Kragten JA, Kuijper A, Liem AH, Linssen GC, Lok DJ, Louwerenburg JW, Mannaerts HF, Michels HR, Nierop PR, Oomen A, Plomp J, Pos L, Posma JL, Remmen JJ, Tans JG, ten Berg JM, Trip MD, Van den Berg BJ, van der Heijden DJ, van Eck JW, van 't Hof AW, van Vlies B, van Wijk LM, Veen G, Visser J, Waltenberger JL, Willems F, Withagen A, Benatar J, Devlin G, Hamer A, Harding S, Richards M, Scott D, Ternouth I, Wilkins G, Bronisz M, Bychowski J, Derlaga B, Dluzniewski M, Dobrzycki S, Drzewiecki A, Gasior Z, Gil R, Grajek S, Hiczkiewicz J, Hoffmann A, Jaworska K, Kawka-Urbanek T, Kolodziej P, Konieczny M, Kornacewicz-Jach Z, Kosmider M, Krauze-Wielicka M, Kubica J, Kuc K, Loboz-Grudzien K, Mazurek W, Miekus P, Ostrowski J, Piepiorka M, Piwowarska W, Ponikowski P, Stopinski M, Szelemej R, Szpajer M, Szwed H, Trojnar R, Trusz-Gluza M, Ujda M, Waszyrowski T, Zarebinski M, Zmudka K, Barranco E, Camilo-Vazquez E, Comulada-Rivera A, Franco E, Matta-Fontanet E, Ortiz-Carrasquillo R, Ruiz L, Belicova M, Dzupina A, Kurray P, Micko K, Murin J, Poliacik P, Spisak V, Stevlik J, Sulej P, Badenhorst JC, Bayat J, Dawood SY, Engelbrecht JM, Essop MR, Gebka MK, Klug E, Lloyd E, Manga P, Naidoo D, Rossouw J, Saaiman JA, Snyders FA, Theron H, Venter TP, Cha KS, Cho BR, Cho YH, Chung NS, Han SJ, Hur SH, Hyon SH, Jeon DW, Jeong MH, Kim SH, Namgung J, Park JS, Park JI, Park SJ, Shin E, Antorrena I, Aros F, Arroyo R, Berrazueta JR, Coronado JL, I Cortada JB, Aviles FF, Goicolea F, Juanatey JR, Garcia JM, Romo AI, Garcia-Aranda VL, de Miguel CM, Elbal LM, Paz MA, Quiles J, Nodar JM, Salvador A, Berglund S, Rosenqvist M, Saldeen-Niléhn K, Samad B, Viklund J, Erne P, Hayoz D, Mach F, Moccetti T, Peter M, Pieper M, Widmer F, Bakhai A, Brady A, Bridges A, Butler R, Chauhan A, de Belder M, Findlay I, Gupta S, Hudson I, Khattar R, Lewis P, Leyva F, Lindsay S, Lip G, Martin S, Murdoch D, Newby D, Pell A, Purvis J, Ray K, Rosen S, Rothman M, Smith D, Travill C, Venkataraman A, Wikinson P, Abbott R, Adkins K, Adolphe A, Ahmed A, Akinboboye O, Akmal M, Albirini A, Altschuller A, Alwine L, Alzohaili O, Apostol J, Arif A, Arora D, Asbill B, Ashchi M, Aslam A, Baine S, Bains S, Baker S, Bareket Y, Barnum O, Barrett-Connor E, Bazzi A, Bedoya R, Benton R, Ben-Yehuda O, Berkery W, Berman K, Bertolet B, Bhagwat R, Bhatti Z, Bilazarian S, Bittner V, Blonder R, Bloom S, Borromeo S, Brett C, Brilakis E, Brown A, Brown D, Brulte S, Budoff M, Burchenal J, Burckhartt B, Burtt D, Call J, Cambier P, Caputo R, Carstens J, Carter E, Chadow H, Chandna H, Chandrasekaran S, Chiu A, Chodnicki D, Cohen Y, Colan D, Cole J, Collard C, Corl J, Cottiero R, Cowan L, Crall F, Cromer M, Dadkhah S, Dave K, Davis B, Day F, Del Core M, Desai A, Desai P, Desai V, DeSanto J, Devireddy K, Dotani I, Duprez D, Duvernoy C, Dykstra G, Edris M, Edwards A, Eilen S, Eisenberg S, Elkin G, Ellis J, El-Sherif T, Emlein G, Erickson B, Ervin W, Fastabend C, Feldman R, Felten W, Fenton S, Fields R, Fischell T, Fishberg R, Flores A, Forgosh L, Forker A, Forman S, Fortuin F, Foster M, Freireich R, Fuleihan D, Gabriel G, George A, Gerber J, Ghai A, Giesler G, Gilbert J, Gilchrist I, Gillespie E, Gips S, Glassberg H, Gogia H, Goldberg R, Goldner D, Goldstein M, Goyal N, Goytia-Leos D, Graham S, Gruberg L, Gudmundsson G, Haidar A, Handel F, Hanke F, Hanlon S, Haque I, Harris J, Haskel E, Hearne S, Heiman M, Held J, Hemphill J, Henderson D, Herndon W, Herrington D, Herrod J, Herzog W, Hilton T, Hinchman D, Hodes Z, Homan J, Hotchkiss D, Howard L, Humiston D, Hunter J, Hussain M, Ibarra J, Iteld B, Izzo M, Jackson B, Jaffrani N, Jamal N, Jan M, Jardula M, Jarmukli N, Jauch W, Jinich D, Johnson D, Jones M, Jovin I, Kabour A, Kahn Z, Kakavas P, Kaluski E, Karlsberg R, Karns A, Karve M, Kashou H, Kashyap M, Kassas S, Kaul S, Kennett J, Kenton D, Kersh E, Kersh R, Kesselbrenner M, Khaira A, Khan B, Khan M, Khan M, Khan M, Khera A, Klancke K, Kleczka J, Klugherz B, Knapp J, Knight P, Knutson T, Kobayashi J, Kopecky S, Korban E, Koren M, Kosinski E, Kotha P, Kotlaba D, Koura F, Kovacich D, Kramer N, Krantzler J, Krishnaswami A, Kruse K, Kukuy E, Lambert C, Landzberg J, Leppo J, Levenson L, Levine G, Lewis L, Lewis S, Lillestol M, Litt M, Little T, Littlefield R, Loh I, Lotfi A, Lovell C, Lowe J, Lui H, Mahal S, Malek B, Malinowski T, Mandak J, Mandviwala M, Marar I, Martin L, Masri B, Massaro J, Matar F, Mathew T, Matthews B, McClure J, McDavid R, McFarlane S, McGlynn S, McGough M, McLellan B, Meckel C, Meilman H, Miller C, Miller M, Minor S, Moscoso R, Moses D, Moses J, Mouhaffel A, Moustoukas N, Mowdy M, Murphy J, Myla S, Nadar V, Naidu J, Nelson C, Nguyen T, Nguyen T, Norwood P, Packer R, Patel D, Patel M, Pearson J, Pederson R, Perlman N, Pickens W, Pieniek M, Pillai K, Polk D, Porterfield J, Portnay G, Purdy D, Quadrel M, Quinlan E, Quyyumi A, Rahman J, Raikhel M, Rama B, Randhawa P, Rashid HU, Reeves R, Revtyak G, Rezkalla S, Roan P, Roberts J, Roehll W, Rogers C, Rozanski J, Safford R, Sahar D, Saltiel F, Saluja M, Samal A, Sarikonda K, Saucedo J, Sayeed S, Schmalfuss C, Schmedtje J, Schoenwalder D, Schwartz G, Schwartz M, Schwartz S, Scott C, Seals A, Seaworth J, Shah A, Shammas N, Shanes J, Sharma M, Short W, Shubrook J, Siegel C, Simpfendorfer C, Simpson P, Singh J, Singh V, Smith KM, Snell P, Solanki R, Sotsky G, Srinivas V, Srivastava N, Staab P, Stapleton D, Stein B, Strain J, Stroh J, Stys T, Sullenberger L, Sumpter M, Sutherland J, Tak T, Tami L, Tejani F, Tekler L, Teniola S, Thomas G, Thomas J, Timmapuri S, Traboulssi M, Treasure C, Treat S, Trevino M, Tummala R, Turk S, Varma J, Vijay N, Viswanath D, Vora K, Voyce S, Wallach S, Weber F, Weinstein D, Weiss M, Welker J, Whitaker J, White J, Whittle J, Wiechmann B, Williams D, Wiseman A, Yasin M, Yasuda T, Yousuf K, Zakhary B, Zarka A, Zaroff J, Zebrack J, Zelman R.

Abstract

BACKGROUND:

Despite contemporary therapies for acute coronary syndrome (ACS), morbidity and mortality remain high. Low levels of high-density lipoprotein (HDL) cholesterol are common among patients with ACS and may contribute to ongoing risk. Strategies that raise levels of HDL cholesterol, such as inhibition of cholesterol ester transfer protein (CETP), might reduce risk after ACS. Dal-OUTCOMES is a multicenter, randomized, double-blind, placebo-controlled trial designed to test the hypothesis that CETP inhibition with dalcetrapib reduces cardiovascular morbidity and mortality in patients with recent ACS.

DESIGN:

The study will randomize approximately 15,600 patients to receive daily doses of dalcetrapib 600 mg or matching placebo, beginning 4 to 12 weeks after an index ACS event. There are no prespecified boundaries for HDL cholesterol levels at entry. Other elements of care, including management of low-density lipoprotein cholesterol, are to follow best evidence-based practice. The primary efficacy measure is time to first occurrence of coronary heart disease death, nonfatal acute myocardial infarction, unstable angina requiring hospital admission, resuscitated cardiac arrest, or atherothrombotic stroke. The trial will continue until 1,600 primary end point events have occurred, all evaluable subjects have been followed for at least 2 years, and 80% of evaluable subjects have been followed for at least 2.5 years.

SUMMARY:

Dal-OUTCOMES will determine whether CETP inhibition with dalcetrapib, added to current evidence-based care, reduces cardiovascular morbidity and mortality after ACS.

PMID:
19958854
[PubMed - indexed for MEDLINE]
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