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

被引：84

作者：

Harrington, Robert A. ^{[1
]}

Van de Werf, Frans ^{[2
]}

Armstrong, Paul W. ^{[3
]}

Aylward, Phil ^{[4
]}

Veltri, Enrico ^{[5
]}

Mahaffey, Kenneth W. ^{[1
]}

Moliterno, David J. ^{[6
,7
]}

Strony, John ^{[5
]}

Wallentin, Lars ^{[8
]}

White, Harvey D. ^{[9
]}

Diaz, Rafael ^{[10
]}

Huber, Kurt ^{[11
]}

Nicolau, Jose Carlos ^{[12
]}

Carlos Prieto, Juan ^{[13
]}

Isaza, Daniel ^{[14
]}

Widimsky, Petr ^{[15
]}

Grande, Peer ^{[16
]}

Nieminen, Markku ^{[17
]}

Montalescot, Gilles ^{[18
]}

Bode, Christoph ^{[19
]}

Wong, Lawrence ^{[20
]}

Ofner, Peter ^{[21
]}

Lewis, Basil S. ^{[22
]}

Ambrosio, Giuseppe

Valgimigli, Marco ^{[23
]}

Ogawa, Hisao ^{[24
]}

Yamaguchi, Jun-ichi ^{[25
]}

Jukema, J. Wouter ^{[26
]}

Cornel, Jan H. ^{[27
]}

Nordrehaug, Jan Erik ^{[28
]}

Ruzyllo, Witold ^{[29
]}

Providencia, Luis ^{[30
]}

Tan, Huay-Cheem ^{[31
]}

Dalby, Anthony ^{[32
]}

Seung-Jung, Park ^{[33
]}

Betriu, Amadeo ^{[34
]}

Cequier, Angel ^{[35
]}

Held, Claes ^{[8
]}

Pfisterer, Mathias

Ming-Fong, Chen ^{[36
]}

Timurkaynak, Timur ^{[37
]}

Storey, Robert F. ^{[38
]}

Chen, Edmond ^{[5
]}

Hudson, Michael P. ^{[39
]}

Lincoff, A. Michael ^{[40
]}

Morrow, David A. ^{[41
]}

Tricoci, Pierluigi ^{[1
]}

Whellan, David ^{[42
]}

机构：

[1] Duke Clin Res Inst, Durham, NC 27705 USA

[2] Katholieke Univ Leuven, Dept Cardiol, Louvain, Belgium

[3] Univ Alberta, Div Cardiol, Edmonton, AB, Canada

[4] Flinders Med Ctr, Dept Cardiovasc Med, Bedford Pk, SA, Australia

[5] Schering Plough Corp, Res Inst, Kenilworth, NJ 07033 USA

[6] Univ Kentucky, Gill Heart Inst, Lexington, KY USA

[7] Univ Kentucky, Div Cardiovasc Med, Lexington, KY USA

[8] Uppsala Clin Res Ctr, Uppsala, Sweden

[9] Green Lane Cardiovasc Serv, Auckland, New Zealand

[10] Inst Cardiovasc Rosario, Rosario, Argentina

[11] Wilhelminenspital Stadt Wien, Vienna, Austria

[12] Univ Sao Paulo, Sch Med, Heart Inst InCor, BR-05508 Sao Paulo, Brazil

[13] Hosp Jose Joaquin Aguirre, Santiago, Chile

[14] Fdn Clin Shaio, Bogota, Colombia

[15] Univ Hosp Vinohrady, Cardioctr, Prague, Czech Republic

[16] Univ Copenhagen Hosp, Ctr Heart, DK-2100 Copenhagen, Denmark

[17] Helsinki Univ Cent Hosp, Div Cardiol, Helsinki, Finland

[18] CHU Pitie Salpetriere, Dept Cardiol, Paris, France

[19] Univ Freiburg Klinikum, Freiburg, Germany

[20] Chinese Univ Hong Kong, Div Neurol, Hong Kong, Hong Kong, Peoples R China

[21] Natl Inst Cardiol, Budapest, Hungary

[22] Heart Hosp, Lady Davis Carmel Med Ctr, Dept Cardiovasc Med, Haifa, Israel

[23] Azienda Osped Univ Ferrara, Cattedra Cardiol, Ferrara, Italy

[24] Kumamoto Univ, Grad Sch Med Sci, Dept Cardiovasc Med, Kumamoto, Japan

[25] Tokyo Womens Med Univ, Heart Inst Japan, Dept Cardiol, Tokyo, Japan

[26] Leiden Univ, Med Ctr, Dept Cardiol, Leiden, Netherlands

[27] Med Ctr Alkmaar, Dept Cardiol, Alkmaar, Netherlands

[28] Univ Bergen, Bergen, Norway

[29] Natl Inst Cardiol, Warsaw, Poland

[30] Hosp Univ Coimbra, Div Cardiol, Coimbra, Portugal

[31] Natl Univ Singapore Hosp, Dept Cardiol, Singapore 117548, Singapore

[32] Univ Witwatersrand, Johannesburg, South Africa

[33] Asan Med Ctr, Seoul, South Korea

[34] Univ Barcelona, Hosp Clin, Barcelona, Spain

[35] Univ Barcelona, Bellvitge Hosp, Div Cardiol, Barcelona, Spain

[36] Natl Taiwan Univ, Coll Med, Taipei 10764, Taiwan

[37] Gazi Univ Hosp, Dept Cardiol, Ankara, Turkey

[38] Univ Sheffield, Cardiovasc Res Unit, Sheffield S10 2TN, S Yorkshire, England

[39] Henry Ford Hosp, Henry Ford Heart & Vasc Inst, Detroit, MI 48202 USA

[40] Cleveland Clin, Coordinating Ctr Clin Res, Cleveland, OH 44106 USA

[41] TIMI Study Grp, Boston, MA USA

[42] Thomas Jefferson Univ, Div Cardiol, Philadelphia, PA 19107 USA

来源：

AMERICAN HEART JOURNAL | 2009年 / 158卷 / 03期

基金：

美国国家卫生研究院;

关键词：

PROTEASE-ACTIVATED RECEPTOR-1; HIGH-RISK PATIENTS; UNFRACTIONATED HEPARIN; CLOPIDOGREL; OUTCOMES; INTERVENTION; ASPIRIN; IMPACT; INHIBITION; PREVENTION;

D O I：

10.1016/j.ahj.2009.07.001

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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. (Am Heart J 2009; 158:327-34.)

引用

页码：327 / U5

页数：12

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