App aims to boost statin adherence in heart patients
NCT ID NCT05777655
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a smartphone app can help people with atherosclerosis (hardening of the arteries) stick to their new statin medication. About 250 adults who need to start a high-dose statin will either receive standard care or standard care plus the app. The main goal is to see if the app leads to a greater drop in LDL (bad) cholesterol after 6 months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 250 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2023
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age \>18 years * Atherosclerosis (neurovascular, cardiac or peripheral) with an indication to start a high intensity statin-therapy (equivalent to 40mg of atorvastatin or 20mg of rosuvastatin; start of statin therapy +/- 10 days of enrolment) * Statin naivety * LDL-C \>100 mg/dl. No older than 21 days Exclusion Criteria: * Inability to take medication independently or to use the mediteo m+ app independently (e.g. people in need of care, people with dementia) * Patient has no own smartphone (no device provided for this study) * Prior drug therapy to lower LDL-C within the last 30 days * Active cancer (defined as a diagnosis of cancer within 6 months before enrolment, any treatment for cancer within the previous 6 months, or recurrent or metastatic cancer) or other severe concomitant disease with a life expectancy of \<6 months * Use of a digital therapy management application (including mediteo or mediteo m+) within the last month * Participation in another interventional trial * Pregnancy * Inability or unwillingness to provide informed consent
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University Hospital, Essen
RECRUITINGEssen, North Rhine-Westphalia, 45147, Germany
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