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==Eligibility Criteria== | ==Eligibility Criteria== | ||
===Inclusion Criteria=== | ===Inclusion Criteria=== | ||
* Heart attack at least 6 weeks prior to study start | |||
===Exclusion Criteria=== | ===Exclusion Criteria=== | ||
* Serum creatinie level greater than 2.0 mg/dL | |||
* Platelet count less than 100,000/µL | |||
* Blood pressure greater than 160/100 | |||
* 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 | |||
* Active heart failure or heart failure hospitalization within 6 months. | |||
* Diagnoses of additional medical conditions that could otherwise limit patient survival | |||
* Inability to tolerate 500-mL infusions weekly. | |||
==Outcomes== | ==Outcomes== | ||
Revision as of 18:09, 19 November 2013
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High Density Lipoprotein Microchapters |
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Diagnosis |
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Treatment |
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Clinical Trials |
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Case Studies |
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TACT On the Web |
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American Roentgen Ray Society Images of TACT |
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Official Title
Trial to Assess Chelation Therapy (TACT)
Objective
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.
Sponsor
Mt. Sinai Medical Center, Miami
Timeline
| Timeline | |
| Start Date | September 2003 |
| Run-In Period | August 2012 |
| End Date | October 2011 |
| Status | Completed |
The previous information was derived from ClinicalTrials.gov on 11/19/2013 using the identification number NCT00044213.
Study Description
| Study Description | |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | |
| Allocation | Randomized |
| Endpoint | Efficacy Study |
| Interventional Model | Factorial Assignment |
| Masking | Double Blind (Subject, Investigator) |
| Study Details | |
| Primary Purpose | Treatment |
| Condition | Coronary artery disease |
| Intervention | EDTA <vs> EDTA placebo High dose vitamin High dose vitamin placebo |
| Study Arms | Active Comparator: EDTA + high dose vitamin Placebo Comparator: EDTA + high dose vitamin placebo Placebo Comparator: EDTA placebo + high dose vitamin Placebo Comparator: EDTA placebo + high dose vitamin placebo |
| Population Size | 1708 |
The previous information was derived from ClinicalTrials.gov on 11/19/2013 using the identification number NCT00044213.
Eligibility Criteria
Inclusion Criteria
- Heart attack at least 6 weeks prior to study start
Exclusion Criteria
- Serum creatinie level greater than 2.0 mg/dL
- Platelet count less than 100,000/µL
- Blood pressure greater than 160/100
- 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
- Active heart failure or heart failure hospitalization within 6 months.
- Diagnoses of additional medical conditions that could otherwise limit patient survival
- Inability to tolerate 500-mL infusions weekly.