Recruiting NA Atherosclerosis

New treatment option for Atherosclerosis

Official title Improving Adherence to Statin Therapy Through a Medication Management Application

ClinicalTrials.gov ID: NCT05777655

What this study is testing

What it's testing
Interventional study to compare standard of care vs standard of care plus the use of a medication therapy management smartphone app (mediteo m+, Mediteo GmbH, Heidelberg) in patients with atherosclerotic cardiovascular disease and indication to start high intensity statin therapy.
  • This is a blinded study.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Age \>18 years
  • Atherosclerosis (neurovascular, cardiac or peripheral) with an indication to start a high intensity statin-therapy (equivalent to 40mg of...
  • Statin naivety
  • LDL-C \>100 mg/dl. No older than 21 days

You likely can't join if

  • 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...
  • Use of a digital therapy management application (including mediteo or mediteo m+) within the last month
  • Participation in another treatment trial
See the full eligibility criteria
Who can join
  • 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...
  • Statin naivety
  • LDL-C \>100 mg/dl. No older than 21 days
What rules you out
  • 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...
  • Use of a digital therapy management application (including mediteo or mediteo m+) within the last month
  • Participation in another treatment trial
  • Pregnancy
  • Inability or unwillingness to provide informed consent

The study team makes the final eligibility decision.

Where it's taking place

  • Essen, North Rhine-Westphalia, Germany

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Essen, North Rhine-Westphalia, Germany. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.