Technology-Assisted Cholesterol Trial in Consumers (TACTiC)

NCT04964544 | Completed Phase 3 Results FDA Drug

• 1 other identifier: D356PL00015
• Study Type: interventional
• Target: 1,196
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

High Cholesterol

Keywords

Cholesterol, Web App

Outcome Measures

Primary Outcomes (3)

• Overall Correct Initial TASS Outcome, Worst Case Imputation, First Co-Primary Endpoint (Self-Selection Population)

  Proportion of participants that had a correct tass outcome at their initial TASS assessment

  Study day -30 to -1, at initial TASS assessment

• Overall Correct Final Use Outcome With Mitigation, Second Co-primary Endpoint (Per Protocol Population)

  Proportion of participants that had a correct tass outcome at their final TASS assessment

  From enrollment to end of the home use period at 180 days, at final TASS Assessment

• Percent Change From Baseline in Verified LDL-C Regardless of Final Use Outcome (AUS ITT Population)

  From enrollment to end of the home use period at 180 days, at final assessment

Secondary Outcomes (7)

• Participants Eligble for Continuous Treatment Who Self-Tested With a Verified LDL-C Retest During Study, Overall and by Subgroups (Per Protocol Population)

  From enrollment to end of the home use period at 180 days

• Participants Who Self-Identify a Stop Use Warning Also Identified by the CMOG, and Stop Medication (Per Protocol Population)

  From enrollment to end of the home use period at 180 days

• Participants Who Self-Identify a Do Not Use Warning Also Identified by the CMOG at Final Use Assessment(Per Protocol Population, Participants Who Had a do Not Use Warning Identified by the CMOG at Final Use Visit)

  From enrollment to end of the home use period at 180 days

• Participants Who Self-Identify an Ask a Doctor Before Use Warning Also Identified by the CMOG at Final Use Assessment (Per Protocol Population, Participants Who Had a do Not Use Warning Identified by the CMOG at Final Use Visit)

  From enrollment to end of the home use period at 180 days

• Participants With Overall Compliance Between 50% and 120%

  From enrollment to end of the home use period at 180 days

Study Arms (1)

Open Label, Single Arm Technology-Assisted Cholesterol Trial

OTHER

Open Label Single Arm study in All-comers population who self-report having concern about high cholesterol or heart health

Combination Product: 5 mg rosuvastatin calcium with a Web App (combination product)

Interventions

5 mg rosuvastatin calcium with a Web App (combination product) COMBINATION_PRODUCT

The combination product will be a Drug (Rosuvastatin calcium 5 mg) and Software as a Medical Device (Web App that features a Technology-Assisted Self-Selection (TASS) tool). Rosuvastatin calcium 5 mg will be taken orally, 1 tablet daily to use for lowering cholesterol, a key risk factor that can lead to heart disease.

Also known as: Crestor 5 mg

Open Label, Single Arm Technology-Assisted Cholesterol Trial

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males, 20-75 years of age
• Respond to advertising regarding a concern about high cholesterol or heart health
• Able to read speak and understand English
• \. Participant reads and signs the Informed Consent form

You may not qualify if:

• The participant or anyone in their household is currently employed by any of the following:
• A pharmacy or pharmaceutical company
• A consumer healthcare company
• A manufacturer of medicines
• A managed care or health insurance company
• A healthcare practice
• An employee of AstraZeneca or Concentrics Research
• The participant has ever been trained or employed as a healthcare professional (physician, nurse, nurse practitioner, physician assistant, pharmacist).
• The participant has, or cannot recall whether he/she has, received an investigational therapy as part of a clinical trial in the previous twelve (12) months
• The participant is not willing to provide contact information.
• Previous enrollment in the present study.
• The participant has a mailing address in Alaska or their mailing address is a Post Office (PO) Box.
• The participant is not willing to complete an eDiary
• The participant is a woman of childbearing potential and is not following contraception guidelines or is not willing to follow contraception guidelines including practicing abstinence or using at least 1 of the following acceptable methods of birth control for at least 1 month prior to entry into the study and for 1 month after study completion: hormonal -oral, implantable, injectable, or transdermal; mechanical - spermicide in conjunction with a barrier such as a condom or diaphragm; intrauterine device; or surgical sterilization of partner.
• The participant does not have access to the internet.

Sponsors & Collaborators

• AstraZeneca: lead
• Concentrics Research: collaborator
• Idea Evolver: collaborator
• The Cleveland Clinic: collaborator

Study Sites (1)

Research Site

Indianapolis, Indiana, 46240, United States

Location

Related Publications (4)

• 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.

  PMID: 18335281 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.

  PMID: 8349060 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.

  PMID: 30586774 BACKGROUND

• 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.

  PMID: 38599257 DERIVED

Related Links

• Study Landing Page
• redacted CSP
• redacted SAP
• redacted CSR Synopsis

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

TACTiC was conducted during the COVID-19 pandemic. However, the pandemic was not judged to adversely impact the quality of the study.

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca

information.center@astrazeneca.com

1-877-240-9479

Study Officials

• William C. Miller, M.D.

  Concentrics Central Medical Operations Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a 6-month, single-arm, uncontrolled technology-assisted Self-Selection and Actual Use Study to evaluate the use of nonprescription rosuvastatin 5 mg in combination with a Web App. It is an open-label study where participants qualify for treatment based on the medical history, laboratory and blood pressure data they enter into the Web App, accessed on their own device on the internet.

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: July 16, 2021
• Study Start: July 8, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: October 30, 2024
• Results First Posted: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

US (1)