PATIENTS NEEDED FOR NATIONAL

INSTITUTES OF HEALTH (NIH) STUDY

TRIAL TO ASSESS CHELATION THERAPY (TACT)

The NIH-sponsored Trial to Assess Chelation Therapy (TACT) (www.tactnih.com) is a research study, which will test the effectiveness of chelation therapy, an alternative therapy for the treatment of coronary heart disease (CHD), for patients who have survived a heart attack.

If you participate in this study, you will receive 28 months of treatment, and be asked to participate in up to 32 months of follow-up. You will not be charged for participating in this exciting study and will receive the study drug and vitamin and mineral supplements.

To be eligible to participate in TACT you must have had a heart attack, be at least 50 years old, not be a recent smoker or have had chelation therapy for at least 5 years.

TRIAL TO ASSESS CHELATION THERAPY (TACT) 8/28/02

(Project Summary)

 Coronary artery disease (CAD) is the most frequent cause of morbidity and mortality in the United States.  At present, standard therapies for CAD include lifestyle modifications, medical therapies and invasive interventions. Despite the ready availability of a large number and variety of treatments of proven benefit, a national survey has shown that over one third of all patients also seek out and receive alternative therapies, including chelation therapy with ethylenediaminetetraacetic acid (EDTA).  The National Center for Complementary and Alternative Medicine (NCCAM) and the National Heart, Lung, and Blood Institute (NHLBI) have recognized the clinical and public health need for a large-scale trial of chelation therapy and funded this trial. 

Chelation therapy, as practiced in the community, 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.  TACT is a randomized clinical trial with a 2 X 2 factorial design to independently test the effects of the standard chelation solution recommended by the American College for Advancement in Medicine (ACAM) versus placebo solution, and the effects of a high-dose supplementation, versus a low dose regimen to simply replace chelation-related losses.  TACT has the following Specific Aims:

• To determine if chelation or high-dose supplements in patients with CAD improve event-free survival;

• To determine if chelation and high-dose supplements are safe in patients with CAD;

• To determine if chelation or high-dose supplements in patients with CAD improve quality of life;

• To determine if chelation or high-dose supplements in patients with CAD are cost effective.

The primary endpoint of this trial will be a composite of: all cause mortality, myocardial infarction, stroke, hospitalization for angina, and coronary revascularization.   TACT will have over 90% power to detect a 25% reduction, and over 80% power to detect a 20% reduction in this primary endpoint.  Major secondary endpoints will include  (1) additional clinical endpoints; (2) safety of the interventions including indices of renal, hepatic, and hematological function, as suggested by the RFA; (3) health-related quality-of-life, as suggested by the RFA;  (4) cost and cost-effectiveness, as suggested by the RFA; (5) plasma markers of oxidative stress and anti-oxidant protection; and (6) plasma markers of endothelial activation and inflammation. 

TACT is a multicenter and multidisciplinary collaboration of the following centers:

The Clinical Coordinating Center (CCC) including the Clinical Units, the Central Pharmacy, and the Central Lab, led by Gervasio Lamas MD, Study Chairman (Mount Sinai Medical Center);

The Data Coordinating Center (DCC), led by Kerry Lee PhD (Duke Clinical Research Institute);

The Economics and Quality of Life Coordinating Center (EQOL Coordinating Center) led by Daniel Mark MD (Duke Clinical Research Institute).

We propose to enroll 2372 patients 50 years of age or older with a prior myocardial infarction. Following baseline assessments, patients will be randomly assigned to receive 40 infusions of either the chelation or placebo solution, administered as 30 weekly infusions followed by 10 bi-monthly infusions.  Each of these 2 groups will additionally be randomized to receive high-dose supplements versus low-dose supplements. If both therapies are effective, this factorial design will permit the estimation of the contribution of each to the overall effect.  All patients will be followed for clinical events until the end of the trial.  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.

To find out more, please contact

Dr. Lisa Merritt

941.906.9484