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

评估螯合疗法 2 (TACT2) DCC 补充过渡资金的试验

• 批准号: 10393120
• 负责人: Kevin J Anstrom
• 金额: $ 107.56万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-30 至 2022-03-10
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10393120
• 关键词: Age-Years; Blood; Canada; Cardiac; Cardiovascular Diseases; Cardiovascular system; Cessation of life; Chelation Therapy; Clinical; Clinical Research; Complementary Health; Coronary; Coronary Arteriosclerosis; Creatinine; DNA; Data Analyses; Data Coordinating Center; Databases; Diabetes Mellitus; Disease-Free Survival; Doctor of Philosophy; Dose; Enrollment; Etiology; Event; Funding; Future; Guidelines; Hospitalization; Infusion procedures; Institutes; Integrative Medicine; Intravenous; Laboratories; Medical center; Metals; Multivitamin; Multivitamins/Minerals; Myocardial Infarction; National Center for Complementary and Alternative Medicine; National Heart, Lung, and Blood Institute; New York City; Oral; Outcome; Patients; Placebos; Principal Investigator; Public Health; Public Health Schools; Publications; Publishing; Randomized; Recurrence; Regimen; Relative Risks; Reporting; Request for Applications; Research Institute; Risk Reduction; Serum; Site; Stroke; Subgroup; Telephone; Testing; Time; United States Food and Drug Administration; United States National Institutes of Health; Universities; Urine; active method; base; biobank; chelation; clinical practice; clinically significant; design; economic evaluation; follow-up; improved; insight; mortality; novel; primary endpoint; randomized placebo controlled trial; response; toxic metal; treatment arm; treatment effect; treatment group; treatment strategy; trial comparing; vitamin therapy

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.

试验评估螯合疗法2 （TACT2）是一项正在进行的多中心美国-加拿大随机安慰剂研究