Trial to Assess Chelation Therapy 2
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Primary Composite Outcome
研究概览
简要总结
Trial to Assess Chelation Therapy 2 (TACT2) is a randomized, double blind controlled factorial clinical trial of edetate disodium-based chelation and high-dose oral vitamins and minerals to prevent recurrent cardiac events in diabetic patients with a prior myocardial infarction (MI).
详细描述
The primary objective of TACT2, therefore, is to determine if the chelation-based strategy increases the time to the first occurrence of any of the components of the TACT2 primary endpoint: all-cause mortality, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina compared to the placebo chelation strategy.
TACT2 is a 2x2 factorial trial testing 40-weekly edetate disodium-based chelation infusions and twice daily high-dose oral multivitamins and multiminerals (OMVM) in a placebo-controlled design.
TACT2 is being carried out to replicate the findings of TACT1, which found a striking reduction of recurrent cardiovascular events in post-MI diabetic patients receiving edetate disodium-based chelation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, 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
- •Age: ≥ 50 years
- •History of diabetes, defined as medical record evidence or patient report of currently using insulin or oral hypoglycemic agents, or with a history of fasting blood glucose measurement of 126 mg/dL or higher, or a history of HbA1c of 6.5% or higher.
- •History of myocardial infarction based on the Universal Definition of MI.
- •When information about the MI hospitalization is available, all MI types except Type 2 qualify for study entry.
- •When information about the MI hospitalization is not available, a wall motion abnormality on imaging or a perfusion defect on scan that corresponds to a coronary distribution, whether or not accompanied by pathological Q waves in the appropriate distribution, will qualify the patient for study entry. This criterion requires a call to the CCC for case review.
排除标准
- •Baseline serum creatinine >2.0 mg/dL.
- •HbA1C >11%.
- •Myocardial infarction within 6 weeks of randomization.
- •History of allergic reactions to EDTA or any other components of the chelation solution, including heparin. Site personnel are to call the CCC to discuss heparin allergy.
- •Coronary or peripheral arterial revascularization procedure performed within the last 6 months.
- •Planned revascularization procedure in the 6 months following enrollment.
- •Heart failure hospitalization within 6 months prior to enrollment or in clinical heart failure at the time of proposed enrollment (such as NYHA Class 3 dyspnea + rales >basilar, and additional signs of fluid overload). Such patients may be treated with diuretics and enrolled when stable.
- •Poor or no venous access in the upper extremities.
- •a. Prior intravenous chelation therapy consisting of > 1 infusion within 5 years; if only 1 infusion took place, patient cannot be enrolled for at least 12 months after said infusion.
- •b. Oral chelation therapy with an approved oral chelating agent within 2 years.
- •Prior participation in TACT.
- •Baseline platelet count <100,
- •History of cigarette smoking within the last 3 months.
- •ALT or AST > 2.0 times the upper limit of normal.
- •Wilson's disease, hemochromatosis, or parathyroid disease.
- •Any medical condition including a current diagnosis of cancer (except non-melanoma skin cancer) that will limit patient survival over the duration of the trial.
- •Any factor that suggests that the potential participant will not be able to adhere to the protocol.
- •Women of child-bearing potential including those with plans for post-menopausal in vitro fertilization or other reproductive technology.
研究组 & 干预措施
Active/Active
Active disodium EDTA (chelation) + Active Oral Multi Vitamins/Minerals (OMVM)
干预措施: disodium EDTA (Drug)
Active/Active
Active disodium EDTA (chelation) + Active Oral Multi Vitamins/Minerals (OMVM)
干预措施: Oral Multi Vitamins/Minerals (OMVM) (Dietary Supplement)
Active/Placebo
Active disodium EDTA (chelation) + Placebo Oral Multi Vitamins/Minerals (OMVM)
干预措施: disodium EDTA (Drug)
Placebo/ Active
Placebo disodium EDTA (chelation) + Active Oral Multi Vitamins/Minerals (OMVM)
干预措施: Oral Multi Vitamins/Minerals (OMVM) (Dietary Supplement)
Placebo/ Active
Placebo disodium EDTA (chelation) + Active Oral Multi Vitamins/Minerals (OMVM)
干预措施: Placebo disodium EDTA (Drug)
Placebo/Placebo
Placebo disodium EDTA (chelation) + Placebo Oral Multi Vitamins/Minerals (OMVM)
干预措施: Placebo disodium EDTA (Drug)
Placebo/Placebo
Placebo disodium EDTA (chelation) + Placebo Oral Multi Vitamins/Minerals (OMVM)
干预措施: Placebo Oral Multi Vitamins/Minerals (OMVM) (Dietary Supplement)
结局指标
主要结局
Primary Composite Outcome
时间窗: 48 month follow-up (median)
Time to first event: myocardial infarction, stroke, hospitalization for unstable angina, coronary revascularization, or death from any cause
次要结局
- Secondary Composite Outcome(48 month follow-up (median))
- Secondary Outcome(All-Cause Mortality was assessed through study completion, up to 48 months (median))
研究者
Gervasio Lamas, MD
TACT2 Study Chair
Mt. Sinai Medical Center, Miami