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.
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.
Petersen
John L
JL
Division of Cardiology and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
Mahaffey
Kenneth W
KW
Becker
Richard C
RC
Goodman
Shaun G
SG
Kleiman
Neal S
NS
Marian
A J
AJ
Stone
Gregg W
GW
Lansky
Alexandra J
AJ
Lincoff
A Michael
AM
Hazen
Stanley L
SL
Nessel
Christopher C
CC
Toro-Figueroa
Luis
L
Tate
Lynn
L
Reist
Craig J
CJ
Cohen
Marc
M
Califf
Robert M
RM
Ferguson
James J
JJ
D000789:Angina, Unstable / Q000188:drug therapy* / Q000235:genetics / Q000503:physiopathology; D000925:Anticoagulants / Q000627:therapeutic use*; D017023:Coronary Angiography; D004562:Electrocardiography; D017984:Enoxaparin / Q000627:therapeutic use*; D006493:Heparin / Q000627:therapeutic use*; D006801:Humans; D015337:Multicenter Studies as Topic; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000235:genetics / Q000503:physiopathology; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D012307:Risk Factors
D000925:Anticoagulants; D017984:Enoxaparin; D006493:Heparin