Trial to Assess Chelation Therapy (TACT)

描述：(申请人提供)回应申请请求 (AT-01-004)由NCCAM发布，我们提出了一种多中心随机 1600名老年患者的临床试验(评估螯合疗法的试验) 50或以上，比较40次标准螯合溶液的输液 由美国高等医学院推荐，而不是40 注射安慰剂。在社区中实践的螯合疗法，也 包括使用高剂量的抗氧化剂、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络合作用，或高剂量补充剂，或两者兼而有之。因此，我们进一步 提出2X2析因设计，以独立检验 高剂量补充，而不是简单地用低剂量方案替代 与螯合相关的损失。此试验的主要终点将是 所有原因的综合死亡，心肌梗塞，中风， 心绞痛住院治疗和充血性心力衰竭住院治疗。 该主端点与RFA一致。Tact将有90多个 检测减少25%的功率，以及超过80%的功率 检测到此主终端减少了20%。大中专 终点将包括(1)心源性死亡或非致命性死亡的组合终点 心肌梗死或非致命性中风；(2) 主要终点；(3)冠状动脉血运重建；(4)冠状动脉的安全性 干预措施包括肾、肝和血液功能指标， (5)与健康相关的生活质量；(6)费用和 成本-效果，如RFA所建议的；(7)臂动脉血流介导 RFA提示的内皮功能；(8)血浆氧化标记物 应激和抗氧化保护，如RFA所建议的；和(9)血浆 血管内皮细胞活化和炎症的标志物，如RFA所示。 TACT的结果将提供一个重要的积极结果或 理性临床决策与健康的信息性空洞结果 政策可以是基础的。

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.