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Extension and Completion of the TACT2 Clinical Trial

May 2021 Council

Lead Division/Office

DEM

Point(s) of Contact

Teresa Jones, M.D.

Executive Summary

The Trial to Assess Chelation Therapy 2 (TACT2) will test if edetate disodium-based chelation and oral multi-vitamins reduces cardiovascular events in people with diabetes and a history of myocardial infarction. The goal of the trial is to test the reproducibility of results from TACT that showed chelation therapy reduces the risk of a cardiovascular event or death by 40% in the pre-defined subgroup of participants with diabetes. Due to the COVID pandemic, the trial was paused without any recruitment or infusions from March to July 2020. The DSMB met in July 2020 and recommended an extension of the trial for minimum follow-up of 2.5 years to offset the reduced enrollment.  The trial has enrolled 1000 participants with retention and infusion completion similar to TACT. NCCIH is the lead institute and requests continued co-funding from NHLBI, NIDDK and NIEHS for the FY21 to FY24 extension. If successful, the trial would provide evidence for a potent therapy to combat the common and deadly complication of diabetes – cardiovascular disease.