Technology-Assisted Cholesterol Trial in Consumers (TACTiC)

Summary

The purpose of this AUS is to evaluate the extent to which participants can safely and effectively self-select, purchase, and use Crestor OTC 5 mg for a 6-month period according to the label.

Timeline

Start

2021-07-08

Primary completion

2023-03-01

Completion

2023-03-01

Publications

• Background Chew LD, Griffin JM, Partin MR, Noorbaloochi S, Grill JP, Snyder A, Bradley KA, Nugent SM, Baines AD, Vanryn M. Validation of screening questions for limited health literacy in a large VA outpatient population. J Gen Intern Med. 2008 May;23(5):561-6. doi: 10.1007/s11606-008-0520-5. Epub 2008 Mar 12.
• Background Davis TC, Long SW, Jackson RH, Mayeaux EJ, George RB, Murphy PW, Crouch MA. Rapid estimate of adult literacy in medicine: a shortened screening instrument. Fam Med. 1993 Jun;25(6):391-5.
• Background Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Jun 18;139(25):e1082-e1143. doi: 10.1161/CIR.0000000000000625. Epub 2018 Nov 10.
• Nissen SE, Hutchinson HG, Wolski K, Watson K, Martin SS, Michos ED, Weintraub WS, Morris M, Cho L, Laffin L, Jacoby D, Ballantyne CM, Ekelund J, Birve F, Menon V, Strzelecki M, Ridker PM. A Technology-Assisted Web Application for Consumer Access to a Nonprescription Statin Medication. J Am Coll Cardiol. 2024 May 28;83(21):2080-2088. doi: 10.1016/j.jacc.2024.03.388. Epub 2024 Apr 8.

Drugs

Indications