Trial DesignThe A-to-Z Trial: Methods and rationale for a single trial investigating combined use of low-molecular-weight heparin with the glycoprotein IIb/IIIa inhibitor tirofiban and defining the efficacy of early aggressive simvastatin therapy☆,☆☆
Section snippets
Overview of study design
The A-to-Z Trial is an ongoing, 2-phase, international, multicenter, randomized study (Figure 1) that focuses on 2 management questions for patients with ACS.
Discussion
The A-to-Z trial is a single study designed to address 2 separate but temporally related clinical questions concerning the management of patients with ACS. The primary objective examines whether early aggressive simvastatin therapy is superior to an “accepted care” regimen as a prevention measure for nSTE-ACS or STE-ACS patients. The secondary objective examines whether randomization to either enoxaparin or unfractionated heparin affects the outcome of the acute management in patients with
Conclusion
The A-to-Z Trial has 2 distinct aims. The primary aim is to define further the role of statin therapy in the treatment of coronary disease. The secondary aim is to advance acute medical therapy for the stabilization of ACS. The design follows the temporal course of a typical hospital admission for ACS, beginning with initial evaluation and acute therapy, followed by stabilization and secondary evaluation, and concluding with initiation of secondary prevention measures. The results of this study
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Guest Editor for this manuscript was Joseph S. Alpert, MD, University of Arizona Health Sciences Center, Tucson, Ariz.
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Reprint requests: Michael A. Blazing, MD, Duke University Medical Center, Box 3126, Erwin Road, Durham, NC 27710. E-mail: [email protected]