Trial to Assess Chelation Therapy 2 (TACT2) DCC Supplemental Bridge Funding

点击翻译按钮获取中文摘要

The Trial to Assess Chelation Therapy 2 (TACT2) is an ongoing multicenter US-Canada randomized placebo- controlled trial that has enrolled 1000 post-MI patients with diabetes and is testing, in a factorial design, whether 40 intravenous edetate disodium-based infusions or placebo infusions and high-dose oral multivitamins or oral placebo can significantly reduce recurrent ischemic cardiac events. The study has completed enrollment and seeks funding for 2.5 additional years to complete follow-up, closeout, analysis, and presentations/publications. This TACT2 continuation proposal consists of a single application by the Data Coordinating Center (DCC) at the Duke Clinical Research Institute (DCRI) led by Principal Investigators (PI) Kevin J. Anstrom PhD and Daniel B. Mark MD, with subcontracts to the Clinical Coordinating Center (CCC) at Mount Sinai Medical Center in Miami Beach FL (Gervasio A. Lamas MD, PI) and the Toxic Metals and Biorepository Core Laboratory at the Columbia University Mailman School of Public Health in New York City (Ana Navas-Acien MD PhD, PI). The DCC, and its subcontracts, will coordinate all post-enrollment activities. This competitive renewal of TACT2 is required to support completion of follow-up, database lock, analyses of study hypotheses, reporting, publication, and dissemination of trial results The combined CCC/DCC Specific Aims of TACT2 for this competitive renewal are to: a. Determine if the chelation-based strategy in patients with diabetes and prior MI improves the primary composite endpoint of event-free survival; b. Determine if the chelation-based strategy in patients with diabetes and prior MI reduces all- cause mortality; c. Perform an economic analysis of the TACT2 chelation strategy; d. Determine whether the metal chelation regimen reduces body metal burden in the active treatment group, and to determine whether treatment effect size is larger among those with larger metal burden; e. Assess the effect of OMVM vs. placebo on clinical outcomes; f. Maintain a biorepository including DNA for future scientific questions. TACT2, if positive, will not only result in the acceptance of chelation into clinical practice and clinical guidelines but also will provide important novel insights into the pathobiology and etiology of coronary artery disease.