The Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA.CER) trial: study design and rationale

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Fältnamn	Indikatorer	Metadata
000		04857naa a2200841 4500
001		oai:DiVA.org:uu-148289
003		SwePub
008		110304s2009 \| \|\|\|\|\|\|\|\|\|\|\|000 \|\|eng\|
024	7	a https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-1482892 URI
024	7	a https://doi.org/10.1016/j.ahj.2009.07.0012 DOI
040		a (SwePub)uu
041		a engb eng
042		9 SwePub
072	7	a ref2 swepub-contenttype
072	7	a art2 swepub-publicationtype
100	1	a Harrington, Robert A.4 aut
245	1 0	a The Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA.CER) trial :b study design and rationale
264	1	b Elsevier BV,c 2009
338		a print2 rdacarrier
520		a Background The protease-activated receptor 1 (PAR-1), the main platelet receptor for thrombin, represents a novel target for treatment of arterial thrombosis, and SCH 530348 is an orally active, selective, competitive PAR-1 antagonist. We designed TRA.CER to evaluate the efficacy and safety of SCH 530348 compared with placebo in addition to standard of care in patients with non-ST-segment elevation (NSTE) acute coronary syndromes (ACS) and high-risk features. Trial design TRA.CER is a prospective, randomized, double-blind, multicenter, phase III trial with an original estimated sample size of 10,000 subjects. Our primary objective is to demonstrate that SCH 530348 in addition to standard of care will reduce the incidence of the composite of cardiovascular death, myocardial infarction (MI), stroke, recurrent ischemia with rehospitalization, and urgent coronary revascularization compared with standard of care alone. Our key secondary objective is to determine whether SCH 530348 will reduce the composite of cardiovascular death, MI, or stroke compared with standard of care alone. Secondary objectives related to safety are the composite of moderate and severe GUSTO bleeding and clinically significant TIMI bleeding. The trial will continue until a predetermined minimum number of centrally adjudicated primary and key secondary end point events have occurred and all subjects have participated in the study for at least I year. The TRA.CER trial is part of the large phase III SCH 530348 development program that includes a concomitant evaluation in secondary prevention. Conclusion TRA.CER will define efficacy and safety of the novel platelet PAR-1 inhibitor SCH 530348 in the treatment of high-risk patients with NSTE ACS in the setting of current treatment strategies.
653		a MEDICINE
653		a MEDICIN
700	1	a Van de Werf, Frans4 aut
700	1	a Armstrong, Paul W.4 aut
700	1	a Aylward, Phil4 aut
700	1	a Veltri, Enrico4 aut
700	1	a Mahaffey, Kenneth W.4 aut
700	1	a Moliterno, David J.4 aut
700	1	a Strony, John4 aut
700	1	a Wallentin, Larsu Uppsala universitet,Uppsala kliniska forskningscentrum (UCR)4 aut0 (Swepub:uu)larswall
700	1	a White, Harvey D.4 aut
700	1	a Diaz, Rafael4 aut
700	1	a Huber, Kurt4 aut
700	1	a Nicolau, Jose Carlos4 aut
700	1	a Carlos Prieto, Juan4 aut
700	1	a Isaza, Daniel4 aut
700	1	a Widimsky, Petr4 aut
700	1	a Grande, Peer4 aut
700	1	a Nieminen, Markku4 aut
700	1	a Montalescot, Gilles4 aut
700	1	a Bode, Christoph4 aut
700	1	a Wong, Lawrence4 aut
700	1	a Ofner, Peter4 aut
700	1	a Lewis, Basil S.4 aut
700	1	a Ambrosio, Giuseppe4 aut
700	1	a Valgimigli, Marco4 aut
700	1	a Ogawa, Hisao4 aut
700	1	a Yamaguchi, Jun-ichi4 aut
700	1	a Jukema, J. Wouter4 aut
700	1	a Cornel, Jan H.4 aut
700	1	a Nordrehaug, Jan Erik4 aut
700	1	a Ruzyllo, Witold4 aut
700	1	a Providencia, Luis4 aut
700	1	a Tan, Huay-Cheem4 aut
700	1	a Dalby, Anthony4 aut
700	1	a Seung-Jung, Park4 aut
700	1	a Betriu, Amadeo4 aut
700	1	a Cequier, Angel4 aut
700	1	a Held, Claes,d 1956-u Uppsala universitet,Uppsala kliniska forskningscentrum (UCR),Institutionen för medicinska vetenskaper4 aut0 (Swepub:uu)clahe947
700	1	a Pfisterer, Mathias4 aut
700	1	a Ming-Fong, Chen4 aut
700	1	a Timurkaynak, Timur4 aut
700	1	a Storey, Robert F.4 aut
700	1	a Chen, Edmond4 aut
700	1	a Hudson, Michael P.4 aut
700	1	a Lincoff, A. Michael4 aut
700	1	a Morrow, David A.4 aut
700	1	a Tricoci, Pierluigi4 aut
700	1	a Whellan, David4 aut
710	2	a Uppsala universitetb Uppsala kliniska forskningscentrum (UCR)4 org
773	0	t American Heart Journald : Elsevier BVg 158:3, s. 327-334q 158:3<327-334x 0002-8703x 1097-6744
856	4 8	u https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-148289
856	4 8	u https://doi.org/10.1016/j.ahj.2009.07.001

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Av författaren/redakt...: Harrington, Robe ...; Van de Werf, Fra ...; Armstrong, Paul ...; Aylward, Phil; Veltri, Enrico; Mahaffey, Kennet ...; visa fler...; Moliterno, David ...; Strony, John; Wallentin, Lars; White, Harvey D.; Diaz, Rafael; Huber, Kurt; Nicolau, Jose Ca ...; Carlos Prieto, J ...; Isaza, Daniel; Widimsky, Petr; Grande, Peer; Nieminen, Markku; Montalescot, Gil ...; Bode, Christoph; Wong, Lawrence; Ofner, Peter; Lewis, Basil S.; Ambrosio, Giusep ...; Valgimigli, Marc ...; Ogawa, Hisao; Yamaguchi, Jun-i ...; Jukema, J. Woute ...; Cornel, Jan H.; Nordrehaug, Jan ...; Ruzyllo, Witold; Providencia, Lui ...; Tan, Huay-Cheem; Dalby, Anthony; Seung-Jung, Park; Betriu, Amadeo; Cequier, Angel; Held, Claes, 195 ...; Pfisterer, Mathi ...; Ming-Fong, Chen; Timurkaynak, Tim ...; Storey, Robert F ...; Chen, Edmond; Hudson, Michael ...; Lincoff, A. Mich ...; Morrow, David A.; Tricoci, Pierlui ...; Whellan, David; visa färre...

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