Trial · NCT04964544
Technology-Assisted Cholesterol Trial in Consumers (TACTiC)
NCT04964544, Phase 3, Completed, AstraZeneca; results first posted 2024-10-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Technology-Assisted Cholesterol Trial in Consumers (TACTiC). Trials, record NCT04964544. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04964544
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Technology-Assisted Cholesterol Trial in Consumers (TACTiC)
- NCT number
- NCT04964544
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,196 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- High Cholesterol
- Interventions
- 5 mg rosuvastatin calcium with a Web App (combination product)
- First posted
- 2021-07-16
- Last updated
- 2024-10-30
- Results first posted
- 2024-10-30
- 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.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Correct Initial TASS Outcome, Worst Case Imputation, First Co-Primary Endpoint (Self-Selection Population) | Study day -30 to -1, at initial TASS assessment | Proportion of participants that had a correct tass outcome at their initial TASS assessment |
| Primary | Overall Correct Final Use Outcome With Mitigation, Second Co-primary Endpoint (Per Protocol Population) | From enrollment to end of the home use period at 180 days, at final TASS Assessment | Proportion of participants that had a correct tass outcome at their final TASS assessment |
| Primary | 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 | 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 | |
| Secondary | 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 Stop Use Warning also identified by the CMOG, and Stop Medication. |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Participants With Overall Compliance Between 50% and 120% | From enrollment to end of the home use period at 180 days | Overall compliance is defined as 100 \* (total number of pills taken) / (Intended duration of treatment in days) |
| Secondary | Participants Who Were Longitudinally Compliant (Per Protocol Population) | From enrollment to end of the home use period at 180 days | An individual is longitudinally compliant if they have 50% to 120% compliance across each supply period. |
| Secondary | Participants Who Were Persistent (Per Protocol Population) | From enrollment to end of the home use period at 180 days | An individual is persistent if they ordered the full 180 days of treatment and were eligible for continuous treatment |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Correct Initial TASS Outcome, Worst Case Imputation, First Co-Primary Endpoint (Self-Selection Population) | Study day -30 to -1, at initial TASS assessment | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Overall Correct Final Use Outcome With Mitigation, Second Co-primary Endpoint (Per Protocol Population) | From enrollment to end of the home use period at 180 days, at final TASS Assessment | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | 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 | Percent change of baseline | MEAN | |
| SECONDARY | 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 in the per protocol analysis set eligble for continuous treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 had a stop use warning identified by the CMOG at final use assessment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 in the per protocol population who had a do not use warning identified by the CMOG at final use visit | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 in the per protocol population who had an ask a doctor before use warning identified by the CMOG at final use visit | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants With Overall Compliance Between 50% and 120% | From enrollment to end of the home use period at 180 days | Participants in the per protocol population whose overall compliance was assessed | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants Who Were Longitudinally Compliant (Per Protocol Population) | From enrollment to end of the home use period at 180 days | Participants in the per protocol population for whom supply period compliance was assessed across all supply periods | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants Who Were Persistent (Per Protocol Population) | From enrollment to end of the home use period at 180 days | Participants in the per protocol population that were eligible for continuous treatment | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Correct Initial TASS Outcome, Worst Case Imputation, First Co-Primary Endpoint (Self-Selection Population) | Nonprescription Rosuvastatin | 1085 | Participants | ||
| Overall Correct Final Use Outcome With Mitigation, Second Co-primary Endpoint (Per Protocol Population) | Nonprescription Rosuvastatin | 1132 | Participants | ||
| Percent Change From Baseline in Verified LDL-C Regardless of Final Use Outcome (AUS ITT Population) | Nonprescription Rosuvastatin | -35.48 | 95% Confidence Interval -36.63 to -34.33 | Percent change of baseline | |
| Participants Eligble for Continuous Treatment Who Self-Tested With a Verified LDL-C Retest During Study, Overall and by Subgroups (Per Protocol Population) | Nonprescription Rosuvastatin | 845 | Participants | ||
| Participants Who Self-Identify a Stop Use Warning Also Identified by the CMOG, and Stop Medication (Per Protocol Population) | Nonprescription Rosuvastatin | 1 | Participants | ||
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) | Nonprescription Rosuvastatin | 46 | Participants | ||
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) | Nonprescription Rosuvastatin | 23 | Participants | ||
| Participants With Overall Compliance Between 50% and 120% | Nonprescription Rosuvastatin | 1089 | Participants | ||
| Participants Who Were Longitudinally Compliant (Per Protocol Population) | Nonprescription Rosuvastatin | 848 | Participants | ||
| Participants Who Were Persistent (Per Protocol Population) | Nonprescription Rosuvastatin | 896 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nonprescription Rosuvastatin | 1,196 | |
| Overall Study | Had an Ask a Doctor Before Use Warning Identified by the CMOG at Final Use Visit | Nonprescription Rosuvastatin | 25 | |
| Overall Study | Had a do Not Use Warning Identified by the CMOG at Final Use Visit | Nonprescription Rosuvastatin | 59 | |
| Overall Study | Participants for Whom CMOG Identified a Stop Use Warning at Final Use Assessment | Nonprescription Rosuvastatin | 2 | |
| Overall Study | COMPLETED | Nonprescription Rosuvastatin | 1,154 | |
| Overall Study | NOT COMPLETED | Nonprescription Rosuvastatin | 42 |
Source ClinicalTrials.gov
Adverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Nonprescription Rosuvastatin | 26 | 1,177 | 27 |
| other | Fatigue | General disorders | Nonprescription Rosuvastatin | 49 | 1,177 | 52 |
| other | Pain | General disorders | Nonprescription Rosuvastatin | 32 | 1,177 | 33 |
| other | Pyrexia | General disorders | Nonprescription Rosuvastatin | 21 | 1,177 | 21 |
| other | Covid-19 | Infections and infestations | Nonprescription Rosuvastatin | 17 | 1,177 | 17 |
| other | Sinusitis | Infections and infestations | Nonprescription Rosuvastatin | 13 | 1,177 | 13 |
| other | Suspected covid-19 | Infections and infestations | Nonprescription Rosuvastatin | 14 | 1,177 | 14 |
| other | Urinary tract infection | Infections and infestations | Nonprescription Rosuvastatin | 26 | 1,177 | 27 |
| other | Sars-cov-2 test positive | Investigations | Nonprescription Rosuvastatin | 126 | 1,177 | 129 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Nonprescription Rosuvastatin | 83 | 1,177 | 113 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nonprescription Rosuvastatin | 1 | 1,177 |
| Total, other adverse events | Nonprescription Rosuvastatin | 493 | 1,177 |
| Total, serious adverse events | Nonprescription Rosuvastatin | 27 | 1,177 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04964544
GET https://conductscience.org/api/trials/v1/NCT04964544/events?page=2