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Coordinated series of studies to evaluate characteristics and mechanisms of acute coronary syndromes in high-risk patients randomly assigned to enoxaparin or unfractionated heparin: design and rationale of the SYNERGY Library.

Publication ,  Journal Article
Petersen, JL; Mahaffey, KW; Becker, RC; Goodman, SG; Kleiman, NS; Marian, AJ; Stone, GW; Lansky, AJ; Lincoff, AM; Hazen, SL; Nessel, CC ...
Published in: Am Heart J
August 2004

Clinical trials and accompanying substudies in patients with acute coronary syndromes (ACS) have over the last several years yielded a wealth of knowledge about the pathophysiology and management of this high-risk condition. The Superior Yield of the New strategy of Enoxaparin, Revascularization, and GlYcoprotein IIb/IIIa inhibitors (SYNERGY) trial is a large-scale, randomized, controlled trial evaluating the effect of enoxaparin and unfractionated heparin on death and myocardial infarction in high-risk patients presenting with non-ST-segment elevation ACS. The SYNERGY Library has been designed as a coordinated series of investigations with simultaneous data acquisition on the same cohort of approximately 500 SYNERGY patients at 60 centers in North America. Specifically, electrocardiograms, coronary arteriograms, inflammatory markers, coagulation studies, and genetic samples will be collected and processed at core laboratory facilities, and the results will be stored in a central repository. This novel strategy for substudy investigation is unprecedented in cardiovascular clinical trials. The goal is to gain significant understanding about this patient population, discover new principles of pathophysiology, identify novel pharmacologic targets, and streamline further drug development. It is hoped that the SYNERGY Library will serve as a model for future substudy design to maximize academic insight within the framework of a large-scale, multicenter trial.

Duke Scholars

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

August 2004

Volume

148

Issue

2

Start / End Page

269 / 276

Location

United States

Related Subject Headings

  • Risk Factors
  • Research Design
  • Randomized Controlled Trials as Topic
  • Patient Selection
  • Myocardial Infarction
  • Multicenter Studies as Topic
  • Humans
  • Heparin
  • Enoxaparin
  • Electrocardiography
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Petersen, J. L., Mahaffey, K. W., Becker, R. C., Goodman, S. G., Kleiman, N. S., Marian, A. J., … SYNERGY Library, . (2004). Coordinated series of studies to evaluate characteristics and mechanisms of acute coronary syndromes in high-risk patients randomly assigned to enoxaparin or unfractionated heparin: design and rationale of the SYNERGY Library. Am Heart J, 148(2), 269–276. https://doi.org/10.1016/j.ahj.2004.03.022
Petersen, John L., Kenneth W. Mahaffey, Richard C. Becker, Shaun G. Goodman, Neal S. Kleiman, A. J. Marian, Gregg W. Stone, et al. “Coordinated series of studies to evaluate characteristics and mechanisms of acute coronary syndromes in high-risk patients randomly assigned to enoxaparin or unfractionated heparin: design and rationale of the SYNERGY Library.Am Heart J 148, no. 2 (August 2004): 269–76. https://doi.org/10.1016/j.ahj.2004.03.022.
Petersen JL, Mahaffey KW, Becker RC, Goodman SG, Kleiman NS, Marian AJ, Stone GW, Lansky AJ, Lincoff AM, Hazen SL, Nessel CC, Toro-Figueroa L, Tate L, Reist CJ, Cohen M, Califf RM, Ferguson JJ, SYNERGY Library. Coordinated series of studies to evaluate characteristics and mechanisms of acute coronary syndromes in high-risk patients randomly assigned to enoxaparin or unfractionated heparin: design and rationale of the SYNERGY Library. Am Heart J. 2004 Aug;148(2):269–276.
Journal cover image

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

August 2004

Volume

148

Issue

2

Start / End Page

269 / 276

Location

United States

Related Subject Headings

  • Risk Factors
  • Research Design
  • Randomized Controlled Trials as Topic
  • Patient Selection
  • Myocardial Infarction
  • Multicenter Studies as Topic
  • Humans
  • Heparin
  • Enoxaparin
  • Electrocardiography