Patient Autonomy and Statin Therapy Adherence

NCT05845580 | Completed DMC

• 1 other identifier: LUHSKC-204
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Statins; Patient autonomy; Red yeast rice extract; Patient-centered care; Primary prevention

Outcome Measures

Primary Outcomes (1)

• Rate of statin compliance

  Based on pharmacy refill records. Values per patient can range from 0-6 according to the number of refills.

  8 months

Secondary Outcomes (1)

• Rate of perceived side-effects from statin use

  8 months

Study Arms (2)

Patient centered care

EXPERIMENTAL

Patients concern of refusing statin therapy will initially be addressed.

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

Guideline-centered care

ACTIVE COMPARATOR

patients will be prescribed the standard of care regardless of their concerns toward statin therapy.

Other: Statin therapy

Interventions

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

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.

Patient centered care

Statin therapy OTHER

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.

Guideline-centered care

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate atherosclerotic cardiovascular disease risk
• Decline statin therapy

You may not qualify if:

• Dementia
• Severe Mental Illness
• History of statin intolerance
• High-risk for atherosclerotic cardiovascular disease
• Currently on lipid lowering therapy
• Currently taking red yeast rice extract
• Pregnant or breast feeding
• Concomitant use of the following drugs: anti-retroviral therapy, niacin, calcineurin inhibitors, mTOR inhibitors, amiodarone, and fibrates

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead
• Minneapolis Heart Institute: collaborator
• Kreiskrankenhaus Rotenburg an der fluda: collaborator
• Klaipėda University: collaborator

Study Sites (1)

Lithuanian University of Health Sciences

Kaunas, LT-50161, Lithuania

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiovascular disease consultant

Model Details: Participants are randomly assigned to receive either atorvastatin therapy or red yeast rice extract and then atorvastatin. The two arms will be run concurrently, and patients in each arm will be assessed for adherence and outcomes over the same period of time.

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 6, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 26, 2024

Record last verified: 2024-08

Locations

LI (1)