Integrating ancillary studies in a large clinical trial: The design and rationale of the APEX library

Ross, 1998, Extended mortality benefit of early postinfarction reperfusion. GUSTO-I Angiographic Investigators. Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries Trial, Circulation, 97, 1549, 10.1161/01.CIR.97.16.1549 Ohman, 1996, Cardiac troponin T levels for risk stratification in acute myocardial ischemia. GUSTO IIA Investigators, N Engl J Med, 335, 1333, 10.1056/NEJM199610313351801 Newby, 2001, Benefit of glycoprotein IIb/IIIa inhibition in patients with acute coronary syndromes and troponin t-positive status: the paragon-B troponin T substudy, Circulation, 103, 2891, 10.1161/01.CIR.103.24.2891 Petersen, 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, 269, 10.1016/j.ahj.2004.03.022 2007, APEX AMI Investigators. Pexelizumab for acute ST-elevation myocardial infarction in patients undergoing primary percutaneous coronary intervention: a randomized controlled trial, JAMA, 297, 43, 10.1001/jama.297.1.43 Armstrong, 2005, Am Heart J, 402, 10.1016/j.ahj.2004.12.015 Armstrong, 2006, Reflections on early stopping of a clinical trial, Am Heart J, 152, 407, 10.1016/j.ahj.2006.06.006 Schroder, 1995, J Am Coll Cardiol, 26, 1657, 10.1016/0735-1097(95)00372-X Armstrong, 2003, ST-segment resolution in ASSENT 3: insights into the role of three different treatment strategies for acute myocardial infarction, Eur Heart J, 24, 1515, 10.1016/S0195-668X(03)00322-1 Fu, 2001, for the ASSENT 2 Investigators. Time to treatment influences the impact of ST-segment resolution on one-year prognosis: insights from ASSENT 2, Circulation, 104, 2653, 10.1161/hc4701.099731 Hindman, 1985, Evaluation of a QRS scoring system for estimating myocardial infarct size. V specificity and method of application of the complete system, Am J Cardiol, 55, 1485, 10.1016/0002-9149(85)90958-0 Wagner, 1982, Evaluation of a QRS scoring system for estimating myocardial infarct size. I specificity and observer agreement, Circulation, 65, 342, 10.1161/01.CIR.65.2.342 Granger, 2003, Pexelizumab, an anti-C5 complement antibody, as adjunctive therapy to primary percutaneous coronary intervention in acute myocardial infarction: the COMplement inhibition in Myocardial infarction treated with Angioplasty (COMMA) trial, Circulation, 108, 1184, 10.1161/01.CIR.0000087447.12918.85 Theroux, 2005, Prognostic significance of blood markers of inflammation in patients with ST-segment elevation myocardial infarction undergoing primary angioplasty and effects of pexelizumab, a C5 inhibitor: a substudy of the COMMA trial, Eur Heart J, 26, 1964, 10.1093/eurheartj/ehi292