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Trial to Assess Chelation Therapy 2- TACT2 CCC

Award Number: UG3AT009149
ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2015
PERIOD OF PERFORMANCE END DATE: 09/29/2016

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Trial to Assess Chelation Therapy 2- TACT2 CCC - ¿ DESCRIPTION (provided by applicant): The purpose of the Trial to Assess Chelation Therapy 2 (TACT2) is to perform a pragmatic and efficient replication of TACT1 in patients with diabetes and a prior heart attack. The results of this trial will determine whether disodium ethylene diamine tetraacetic acid (Na2EDTA) chelation therapy receives approval from the US Food and Drug Administration (FDA) and is subsequently accepted to reduce the risk of major adverse events from coronary artery disease (CAD) in patients with diabetes. TACT2, if positive, will also promote research into the mechanism(s) of benefits and provide novel insights into the pathobiology of CAD. The Trial to Assess Chelation Therapy (TACT1) was developed in response to a Request for Applications from NCCAM and the National Heart Lung and Blood Institute (NHLBI) to address the concern that chelation use was widespread but there were no reliable data on either safety or efficacy. Surprisingly to cardiologists, the chelation strategy, combination of up to 40 infusions with intravenous disodium EDTA plus oral multivitamins and multiminerals (OMVM) compared with intravenous and oral placebo, led to a significant reduction in the time to first recurrent cardiovascular event in patients with prior myocardial infarction (MI), age 50 or older, already treated with standard evidence based medical therapies (HR 0.74; 95% confidence intervals (CI) 0.57- 0.95; p=0.016. The 5-year number needed to treat (NNT) was 12. In the prespecified subgroup with diabetes (n=633), the results were dramatic: the chelation-based strategy reduced the composite primary clinical endpoint by 51% (HR 0.49, 95%CI (0.33 0.75); p<0.001, 5-year NNT 5.5) and reduced total mortality by 43% (p=0.011, 5-year NNT 12). As a result of these findings, and because of the public health impact of cardiovascular disease and of diabetes, we have been encouraged by the National Institutes of Health (NIH) and the FDA to confirm the results of TACT1. The three Specific Aims of TACT2 are: 1) To determine if the chelation-based strategy in patients with diabetes and prior MI improves event-free survival; 2) To determine if the chelation-based strategy in patients with diabetes and prior MI reduces mortality; 3) To perform a cost-effectiveness analysis of the TACT2 chelation strategy. TACT2 will enroll 1200 diabetic patients 50 years of age or older with a prior MI and a serum creatinine of 2.0 mg/dL or less. Patients will be randomly allocated (1:1) to receive either chelation + OMVM or double placebo and followed for clinical events until the end of the 5 year trial. The primary endpoint will be a composite of all-cause mortality, recurrent MI, stroke, coronary revascularization, and hospitalization for unstable angina. A Clinical Events Committee masked to treatment assignment will adjudicate events. Principal secondary endpoints will include: (1) all-cause mortality; (2) a composite of cardiovascular mortality, recurrent MI, or stroke; and (3) safety.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2015	MOUNT SINAI MEDICAL CENTER OF FLORIDA, INC.	4300 ALTON RD	MIAMI BEACH	FL	33140	MIAMI-DADE	USA	Research and Training in Complementary and Integrative Health	000	1	7/26/2019	NEW	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = -$62,815 )
2017	2016	MOUNT SINAI MEDICAL CENTER OF FLORIDA, INC.	4300 ALTON RD	MIAMI BEACH	FL	33140	MIAMI-DADE	USA	Research and Training in Complementary and Integrative Health	000	1	1/26/2017	SUPPLEMENT FOR EXPANSION	-$62,815
														Subtotal = -$62,815

Issue Date FY: 2016 ( Subtotal = $64,326 )
2016	2016	MOUNT SINAI MEDICAL CENTER	4300 ALTON ROAD	MIAMI BEACH	FL	33140	MIAMI-DADE	USA	Research and Training in Complementary and Integrative Health	000	1	11/19/2015	SUPPLEMENT FOR EXPANSION	$64,326
														Subtotal = $64,326

Issue Date FY: 2015 ( Subtotal = $400,000 )
2015	2015	MOUNT SINAI MEDICAL CENTER	4300 ALTON ROAD	MIAMI BEACH	FL	33140	MIAMI-DADE	USA	Research and Training in Complementary and Integrative Health	000	1	9/15/2015	NEW	$400,000
														Subtotal = $400,000

Grand Total All Awards = $401,511

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Trial to Assess Chelation Therapy 2- TACT2 CCC

Award Number: UG3AT009149

ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/30/2015

PERIOD OF PERFORMANCE END DATE: 09/29/2016

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