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Patient Autonomy and Statin Therapy Adherence

NCT05845580 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-08-26

No results posted yet for this study

Summary

The rationale for the Patient Autonomy and Statin Therapy Adherence (PASTA) trial is based on the fact that statin therapy is a highly effective and evidence-based treatment for reducing the risk of cardiovascular disease. However, despite the proven benefits of statin therapy, a significant proportion of patients decline to take statins due to concerns about side effects, safety, or a preference for alternative treatments.

One potential strategy to improve statin adherence in patients who decline therapy is to give patients more autonomy in selecting their treatment options. By offering patients a choice between a traditional statin medication (atorvastatin) or a "natural" statin alternative (red yeast rice extract) and involving them in the goal-setting process for their LDL-C levels, patients may feel more empowered and engaged in their own care.

The PASTA trial aims to evaluate whether greater patient autonomy leads to improved adherence to statin therapy in patients who decline initial therapy. By measuring the impact of patient autonomy on statin adherence, the study results may provide valuable insights into how to improve patient engagement and health outcomes in a population that may be hesitant to initiate statin therapy.

Conditions

  • Drug Adherence

Interventions

OTHER

Red yeast rice extract initial therapy followed later on by statin therapy

Patients will be offered red yeast rice extract to achieve a target LDL-cholesterol level of \<2.6 mmol/L, as recommended by the 2019 ESC/EAS guidelines. If a patient's LDL-cholesterol level remains above the target during follow-up, they will be informed that the natural alternative was ineffective, and they will be prescribed atorvastatin.

OTHER

Statin therapy

Patients will be provided reassurance through a short, semi-structured discussion on the excellent safety profile of statins, similar to a typical interaction between a clinician and patient. They will then be prescribed atorvastatin.

Sponsors & Collaborators

  • Minneapolis Heart Institute

    collaborator OTHER

  • Kreiskrankenhaus Rotenburg an der fluda

    collaborator UNKNOWN

  • Klaipėda University

    collaborator OTHER

  • Lithuanian University of Health Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2024-06-01
Completion
2024-08-01

Countries

  • Lithuania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05845580 on ClinicalTrials.gov