Trial to Assess Chelation Therapy (TACT) - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Trial to Assess Chelation Therapy (TACT)

Official Title ^†

Trial to Assess Chelation Therapy (TACT)

Brief Summary

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.

Detailed Description

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, hospitalization for angina and hospitalization for congestive heart failure.

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.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Primary Outcome Measure ^†

All cause mortality, myocardial infarction, stroke, hospitalization for angina and hospitalization for congestive heart failure [ Time Frame: Measured throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measure ^†

Condition ^†

Coronary Artery Disease

Intervention ^†

Drug: EDTA chelation therapy
Drug: Placebo infusions

MEDLINE PMIDs

Links

View the NIH press release and Q & A regarding the study from here. This link exits the ClinicalTrials.gov site

Sites are being added frequently; click here to view a current list from the NCCAM web site. This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

1950

Start Date ^†

September 2003

Completion Date

July 2010

Eligibility Criteria ^†

Inclusion Criteria for Participants:

Heart attack at least 6 weeks prior to study start

Exclusion Criteria for Participants:

Chelation therapy within 5 years prior to study start
History of allergic reactions to EDTA or any of the therapy's components
Coronary or carotid revascularization procedures within 6 months prior to study start or a scheduled revascularization
Cigarette smoking within 3 months prior to study start
Childbearing potential
History of liver disease
Diagnoses of additional medical conditions that could otherwise limit patient survival

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: NCCAM Clearinghouse

1-888-644-6226

Location Countries ^†

United States, Canada

Administrative Information Fields

NCT ID ^†

NCT00044213

Organization ID

U01 HL092607

Secondary IDs ^††

Study Sponsor ^†

National Heart, Lung, and Blood Institute (NHLBI)

Collaborators ^††

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators ^†

Study Director:

Gervasio A Lamas, M.D.

University of Miami

Information Provided By

National Heart, Lung, and Blood Institute (NHLBI)

Verification Date

October 2008

First Received Date ^†

August 22, 2002

Last Updated Date

October 7, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.