Technology-Assisted Cholesterol Trial in Consumers (TACTiC) (TACTiC)

• ClinicalTrials.gov Identifier: NCT04964544
• Recruitment Status: Completed
• First Posted: July 16, 2021
• Last Update Posted: January 24, 2024
• Sponsor: AstraZeneca
• Collaborators: Concentrics Research LLC; Concentrics Research - STATKING JV; Idea Evolver; The Cleveland Clinic
• Information provided by (Responsible Party): AstraZeneca

Study Description

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.

Condition or disease	Intervention/treatment	Phase
High Cholesterol	Combination Product: 5 mg rosuvastatin calcium with a Web App (combination product)	Phase 3

Detailed Description:

This is a single-arm, interventional, phase III Self-Selection (SS) and Actual Use Study (AUS) using a technology assisted tool within a Web App. The open-label study will enroll approximately 1220 participants who qualify for treatment based on the data they enter into the Web App of which an estimated 1000 participants will ultimately proceed to the use phase.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1189 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: 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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase III, 6-Month Self-selection and Actual Use Study for Rx-to-OTC Switch of Rosuvastatin 5 mg Once-daily in Combination With a Web App
• Actual Study Start Date: July 8, 2021
• Actual Primary Completion Date: March 1, 2023
• Actual Study Completion Date: March 1, 2023

Arms and Interventions

Arm

Intervention/treatment

Open Label, Single Arm Technology-Assisted Cholesterol Trial; 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); 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.; Other Name: Crestor 5 mg

Outcome Measures

Primary Outcome Measures :

1. Percentage of participants with an Overall Correct (correct + mitigated) Initial TASS Outcome at the initial self-selection [ Time Frame: -30 to -1 days from Day 0 Drug Delivery ]
   Evaluate initial TASS outcome (for participants deemed "OK to Use" or those with an "Ask a Doctor" outcome who contact a doctor and are permitted to continue treatment) compared to the TASS outcome obtained using clinician-verified medical and laboratory data
2. Percentage of participants with an Overall Correct (correct + mitigated) Final Use Outcome at the final use assessment [ Time Frame: Through study completion, approximately 6 months ]
   Evaluate that participants are properly using nonprescription rosuvastatin during the use period as assessed by their ability to correctly enter their ongoing health status into the Web App to get the correct outcome or through the medical and medication history in those participants who fail to complete a final TASS use assessment
3. Percent change from baseline in verified LDL-C to Visit 2 [ Time Frame: Through study completion, approximately 6 months ]
   Effectiveness in lowering LDL-C in participants regardless of final use outcome

Secondary Outcome Measures :

1. Cholesterol retest within 6 months of starting medication (that was verified at Visit 2, not including study mandated tests) by at least 60% of participants who are eligible for continuous treatment [ Time Frame: Through study completion, approximately 6 months ]
   Compliance with cholesterol retesting within 6 months
2. Percentage of participants who correctly self-identify as having a "Stop Use" warning and stop medication [ Time Frame: Through study completion, approximately 6 months ]
   Compliance with "Stop Use" warnings
3. Percentage of participants who correctly self-identify as having a "Do Not Use" warning at the final use assessment [ Time Frame: Through study completion, approximately 6 months ]
   Compliance with "Do Not Use" warnings
4. Percentage of participants who correctly self-identify as having an "Ask a Doctor Before Use" warning at the final use assessment [ Time Frame: Through study completion, approximately 6 months ]
   Compliance with "Ask a Doctor Before Use" warnings
5. Percentage of participants with overall compliance between 50% and 120% as determined by pill count [ Time Frame: Through study completion, approximately 6 months ]
   Compliance with Continuous Dosing
6. Percentage of participants with longitudinal compliance between 50% and 120% across all supply periods as determined using eDiary data [ Time Frame: Through study completion, approximately 6 months ]
   Compliance with Continuous Dosing
7. Percentage of participants who were persistent as determined by reorder data from the Web App [ Time Frame: Through study completion, approximately 6 months ]
   Compliance with Continuous Dosing

Other Outcome Measures:

1. List of the number and percentage of incorrect entries and the reasons for incorrect TASS entries for initial TASS [ Time Frame: -30 to -1 days from Day 0 Drug Delivery ]
   Evaluate the incorrect entries and the reasons for incorrect TASS entries for each question on the initial TASS assessment
2. List of the number and percentage of incorrect entries and the reasons for incorrect TASS entries for final TASS [ Time Frame: Through study completion, approximately 6 months ]
   Evaluate the incorrect entries and the reasons for incorrect TASS entries for each question on the final TASS assessment
3. Percentage of participants who correctly self-identify as having a "Stop Use" warning and speak to a doctor [ Time Frame: Through study completion, approximately 6 months ]
   Compliance with speak to a doctor component of the "Stop Use" warnings
4. For participants who correctly self-identify a "Stop Use" warning and stopped the medication, the date from when participant self-identifies a "Stop Use" warning to the date the medication was stopped [ Time Frame: Through study completion, approximately 6 months ]
   Timeframe for complying with "Stop Use" warnings
5. For participants who correctly self-identify a "Stop Use" warning and talked to a doctor, the date from when a participant self-identifies a "Stop Use" warning to the date their doctor was contacted [ Time Frame: Through study completion, approximately 6 months ]
   Timeframe for complying with "Stop Use" warnings
6. For participants who correctly self-identify as having a "Do Not Use" warning at final use assessment, the date from when a participant self-identifies a "Do Not Use" warning to the date the medication was stopped [ Time Frame: Through study completion, approximately 6 months ]
   Timeframe for complying with "Do Not Use" warnings
7. Percentage of participants who correctly self-identify as having an "Ask a Doctor Before Use" warning and speak to a doctor [ Time Frame: Through study completion, approximately 6 months ]
   Compliance with speak to a doctor component of the "Ask a Doctor Before Use" warnings
8. For participants who correctly self-identify as having an "Ask a Doctor Before Use" warning at final use assessment, the date from participant receiving an "Ask a Doctor Before Use" warning to the date their doctor was contacted [ Time Frame: Through study completion, approximately 6 months ]
   Timeframe for complying with "Ask a Doctor Before Use" warnings
9. Difference in % change from baseline in LDL-C between participants who had a retest during the study with a verified source and those who did not retest but had a study mandated test completed based on participants eligible for continuous treatment at V2 [ Time Frame: Through study completion, approximately 6 months ]
   Evaluate effectiveness in lowering LDL-C in different participant subgroups
10. Percent change from baseline in verified LDL-C at Visit 2 stratified by level of overall compliance (<50%, 50-120% and >120%) and by 50-120% supply period compliance across all supply periods in participants eligible for continuous treatment [ Time Frame: Through study completion, approximately 6 months ]
    Evaluate LDL-C lowering relative to level of dosing compliance

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Males, 20-75 years of age
2. Females, 20-75 years of age (This inclusion criterion will be applied until 50 females under the age of 50 years complete the initial TASS assessment in the Web App). After this quota of 50 females under the age of 50 years old is met, the inclusion criterion will be revised to females 50-75 years old).
3. Respond to advertising regarding a concern about high cholesterol or heart health
4. Able to read speak and understand English

Additional Criteria for Inclusion for Actual Use (at Virtual Visit 1)

1. Participant reads and signs the Informed Consent form

Exclusion Criteria:

1. 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
2. The participant has ever been trained or employed as a healthcare professional (physician, nurse, nurse practitioner, physician assistant, pharmacist).
3. 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
4. The participant is not willing to provide contact information.
5. Previous enrollment in the present study.
6. The participant has a mailing address in Alaska or their mailing address is a Post Office (PO) Box.
7. The participant is not willing to complete an eDiary
8. 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.
9. The participant does not have access to the internet.
10. The participant does not have an email address or the ability to receive emails.
11. The participant responds to the Single Item Literacy Screener 2 (SILS2) question (See References) with either 'extremely' or 'quite a bit.' (If the quota for normal literacy is met, but the limited literacy target is not met, the SILS2 exclusion will be used to help increase the percentage of limited literacy participants at Virtual Visit 1. Participants identified as normal literacy by Rapid Estimate of Adult Literacy in Medicine [REALM] testing at Virtual Visit 1 will not be excluded from entry into the treatment phase of the study.)
12. Inability to conduct interviews in a private location so that sensitive information about the participant or study would not be overheard by others not permitted to hear such information.

Additional Criteria for Exclusion from Actual Use (at Virtual Visit 1)

Confirmation by Concentrics Central Medical Operations Group (CMOG) clinician:

1. That the participant is pregnant, as determined by an approved self-administered OTC urine pregnancy test (UPT) conducted for all female participants of childbearing potential (Female participants who are not post-menopausal or surgically sterile).
2. That the participant is breastfeeding.
3. That the participant has an allergy to rosuvastatin.

Contacts and Locations

Locations

United States, Indiana

Research Site

Indianapolis, Indiana, United States, 46240

Sponsors and Collaborators

AstraZeneca

Concentrics Research LLC

Concentrics Research - STATKING JV

Idea Evolver

The Cleveland Clinic

Investigators

• Principal Investigator: William C. Miller, M.D.; Concentrics Central Medical Operations Group

More Information

Additional Information:

Study Landing Page 

Publications:

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.

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.

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. Erratum In: Circulation. 2019 Jun 18;139(25):e1182-e1186. Circulation. 2023 Aug 15;148(7):e5.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT04964544
• Other Study ID Numbers: D356PL00015
• First Posted: July 16, 2021
• Last Update Posted: January 24, 2024
• Last Verified: January 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• Supporting Materials: Study Protocol; Statistical Analysis Plan (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.

• URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AstraZeneca:

Cholesterol, Web App

Additional relevant MeSH terms:

Hypercholesterolemia; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Rosuvastatin Calcium; Calcium; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors