Trial to Assess Chelation Therapy (TACT)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,708
- 试验地点
- 86
- 主要终点
- A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina.
研究概览
简要总结
The purpose of this study is to determine the safety and effectiveness of ethylene diamine tetra-acetic (EDTA) chelation therapy in individuals with coronary artery disease.
详细描述
EDTA chelation therapy involves repeated administrations of a synthetic amino acid to reduce atherosclerotic plaque and other mineral deposits throughout the cardiovascular system.
Participants will be randomly assigned to receive 40 infusions of either the standard chelation solution or placebo. The primary endpoint of this trial will be a composite of all cause mortality, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
EDTA placebo + high dose vitamin
Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
干预措施: High Dose Vitamin (Dietary Supplement)
EDTA + high dose vitamin placebo
Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
干预措施: High Dose Vitamin Placebo (Dietary Supplement)
EDTA placebo + high dose vitamin
Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
干预措施: EDTA Placebo (Drug)
EDTA + high dose vitamin
Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
干预措施: EDTA (Drug)
EDTA + high dose vitamin
Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
干预措施: High Dose Vitamin (Dietary Supplement)
EDTA + high dose vitamin placebo
Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
干预措施: EDTA (Drug)
EDTA placebo + high dose vitamin placebo
Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
干预措施: EDTA Placebo (Drug)
EDTA placebo + high dose vitamin placebo
Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
干预措施: High Dose Vitamin Placebo (Dietary Supplement)
结局指标
主要结局
A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina.
时间窗: Measured over a maximum 5-year follow-up period- 55 month median
Number of patients with events (composite of death from any cause, MI, stroke, coronary revascularization or hospitalization for angina) Events were centrally adjudicated where available; otherwise site reported events were used.
次要结局
- A Composite of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke.(Measured over a maximum 5-year follow-up period- 55 month median)
研究者
Gervasio Lamas, MD
Chair, Department of Medicine- Chief, Division of Cardiology
Mt. Sinai Medical Center, Miami