Trial to Assess Chelation Therapy (TACT)

描述：（由申请人提供）对申请要求的回应 （AT-01-004），我们提出了一个多中心随机 在1600名患者中进行的临床试验（评估螯合治疗[TACT]的试验） 50岁或以上，比较40次标准螯合溶液输注 美国医学促进学院推荐的40名 注射安慰剂。螯合疗法，在社区实践中，也 包括使用高剂量的抗氧化维生素和矿物质补充剂。 因此，螯合疗法的任何临床益处可能是由于 EDTA螯合或高剂量补充剂或两者兼而有之。因此，我们进一步 提出了一个2X2析因设计，以独立测试的影响， 高剂量补充剂，而低剂量方案， 螯合相关的损失。本试验的主要终点是 全因死亡率、心肌梗死、卒中 因心绞痛住院和因充血性心力衰竭住院。 该主要终点与RFA一致。TACT将有超过90个 %的功率来检测25%的减少，超过80%的功率来检测 检测到这个主要终点降低了20%。主要次要 终点将包括（1）心源性死亡或非致死性的联合终点 心肌梗死或非致命性卒中;（2） 主要终点;（3）冠状动脉血运重建;（4）安全性 干预措施，包括肾、肝和血液功能指标， RFA建议的;（5）健康相关的生活质量;（6）成本和 RFA建议的成本效益;（7）肱动脉血流介导 内皮功能，如RFA所示;（8）血浆氧化标志物 RFA建议的应激和抗氧化保护;以及（9）血浆 内皮活化和炎症的标志物，如RFA所示。 TACT的结果将提供显著的阳性结果或 理性临床决策和健康 政策是可以依据的。

DESCRIPTION: (provided by applicant) In response to the Request for Application (AT-01-004) released by NCCAM, we are proposing a multi-center randomized clinical trial (Trial to Assess Chelation Therapy [TACT]) in 1600 patients age 50 or older comparing 40 infusions of the standard chelation solution recommended by the American College for Advancement in Medicine versus 40 infusions of placebo. Chelation therapy, as practiced in the community, also includes the use of high dose antioxidant vitamin and mineral supplements. Thus, any clinical benefit of chelation therapy may be due either to the effect of EDTA chelation, or high dose supplements, or both. Therefore, we are further proposing a 2X2 factorial design to independently test the effects of a high-dose supplementation, versus a low dose regimen to simply replace chelation-related losses. The primary endpoint of this trial will be a composite of all cause mortality, myocardial infarction, stroke, hospitalization for angina and hospitalization for congestive heart failure. This primary endpoint is consistent with the RFA. TACT will have over 90 percent power to detect a 25 percent reduction, and over 80 percent power to detect a 20 percent reduction in this primary endpoint. Major secondary endpoints will include (1) a combined endpoint of cardiac death, or nonfatal myocardial infarction, or nonfatal stroke; (2) the individual components of the primary endpoint; (3) coronary revascularization; (4) safety of the interventions including indices of renal, hepatic, and hematological function, as suggested by the RFA; (5) health-related quality-of-life; (6) cost and cost-effectiveness, as suggested by the RFA; (7) brachial artery flow-mediated endothelial function, as suggested by the RFA; (8) plasma markers of oxidative stress and anti-oxidant protection, as suggested by the RFA; and (9) plasma markers of endothelial activation and inflammation, as suggested by the RFA. The results of TACT will provide either a significant positive result or an informative null result upon which rational clinical decision-making and health policy can be based.