drugset / Trial / NCT02733185
Trial to Assess Chelation Therapy 2
Phase 3
Completed
1000 enrolled
Mt. Sinai Medical Center, Miami
Duke Clinical Research Institute · collabNational Center for Complementary and Integrative Health (NCCIH) · collabNational Heart, Lung, and Blood Institute (NHLBI) · collab
RandomizedFactorialTriple-blindPrevention
Summary
Trial to Assess Chelation Therapy 2 (TACT2) is a randomized, double blind controlled factorial clinical trial of edetate disodium-based chelation and high-dose oral vitamins and minerals to prevent recurrent cardiac events in diabetic patients with a prior myocardial infarction (MI).
Timeline
- Start
- 2016-10-01
- Primary completion
- 2023-06-30
- Completion
- 2023-06-30
Publications
- Background Lamas GA, Goertz C, Boineau R, Mark DB, Rozema T, Nahin RL, Lindblad L, Lewis EF, Drisko J, Lee KL; TACT Investigators. Effect of disodium EDTA chelation regimen on cardiovascular events in patients with previous myocardial infarction: the TACT randomized trial. JAMA. 2013 Mar 27;309(12):1241-50. doi: 10.1001/jama.2013.2107.
- Background Escolar E, Lamas GA, Mark DB, Boineau R, Goertz C, Rosenberg Y, Nahin RL, Ouyang P, Rozema T, Magaziner A, Nahas R, Lewis EF, Lindblad L, Lee KL. The effect of an EDTA-based chelation regimen on patients with diabetes mellitus and prior myocardial infarction in the Trial to Assess Chelation Therapy (TACT). Circ Cardiovasc Qual Outcomes. 2014 Jan;7(1):15-24. doi: 10.1161/CIRCOUTCOMES.113.000663. Epub 2013 Nov 19.
- Background Lamas GA, Boineau R, Goertz C, Mark DB, Rosenberg Y, Stylianou M, Rozema T, Nahin RL, Terry Chappell L, Lindblad L, Lewis EF, Drisko J, Lee KL. EDTA chelation therapy alone and in combination with oral high-dose multivitamins and minerals for coronary disease: The factorial group results of the Trial to Assess Chelation Therapy. Am Heart J. 2014 Jul;168(1):37-44.e5. doi: 10.1016/j.ahj.2014.02.012. Epub 2014 Apr 2.
- Background Lamas GA, Goertz C, Boineau R, Mark DB, Rozema T, Nahin RL, Drisko JA, Lee KL. Design of the Trial to Assess Chelation Therapy (TACT). Am Heart J. 2012 Jan;163(1):7-12. doi: 10.1016/j.ahj.2011.10.002.
- Background Lamas GA, Anstrom KJ, Navas-Acien A, Boineau R, Kim H, Rosenberg Y, Stylianou M, Jones TLZ, Joubert BR, Santella RM, Escolar E, Aude YW, Fonseca V, Elliott T, Lewis EF, Farkouh ME, Nathan DM, Mon AC, Gosnell L, Newman JD, Mark DB; TACT2 Investigators. The trial to assess chelation therapy 2 (TACT2): Rationale and design. Am Heart J. 2022 Oct;252:1-11. doi: 10.1016/j.ahj.2022.05.013. Epub 2022 May 19.
- Background Navas-Acien A, Santella RM, Joubert BR, Huang Z, Lokhnygina Y, Ujueta F, Gurvich I, LoIacono NJ, Ravalli F, Ward CD, Jarrett JM, Salazar AL, Boineau R, Jones TLZ, Mark DB, Newman JD, Nathan DM, Anstrom KJ, Lamas GA. Baseline characteristics including blood and urine metal levels in the Trial to Assess Chelation Therapy 2 (TACT2). Am Heart J. 2024 Jul;273:72-82. doi: 10.1016/j.ahj.2024.04.005. Epub 2024 Apr 15.
- Ujueta F, Lamas GA, Anstrom KJ, Navas-Acien A, Boineau R, Rosenberg Y, Stylianou M, Jones TLZ, Joubert BR, Yu Q, Wen J, Nemeth H, Huang Z, Fonseca V, Nathan DM, Uwaifo G, Arenas IA, Luo L, Baker J, Visentin D, Paixao A, Schmedtje JF Jr, Mark DB; TACT2 Investigators. Multivitamins After Myocardial Infarction in Patients With Diabetes: A Randomized Clinical Trial. JAMA Intern Med. 2025 May 1;185(5):540-548. doi: 10.1001/jamainternmed.2024.8408.
- Lamas GA, Anstrom KJ, Navas-Acien A, Boineau R, Nemeth H, Huang Z, Wen J, Rosenberg Y, Stylianou M, Jones TLZ, Joubert BR, Yu Q, Santella RM, Mon AC, Ujueta F, Escolar E, Nathan DM, Fonseca VA, Aude YW, Ehrman JK, Elliott T, Prashad R, Lewis EF, Lopes RD, Farkouh ME, Elliott AM, Newman JD, Mark DB; TACT2 Investigators. Edetate Disodium-Based Chelation for Patients With a Previous Myocardial Infarction and Diabetes: TACT2 Randomized Clinical Trial. JAMA. 2024 Sep 10;332(10):794-803. doi: 10.1001/jama.2024.11463.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Edetate Calcium Disodium | Unknown | — | Intravenous |