Supportive Care for High Cholesterol

(ALLTOP Trial)

Recruiting at 1 trial location

Overseen By Jeffrey N Feldman, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Atlantic Health System

Disqualifiers: Pregnancy, Incarceration, Terminal illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks to improve treatments for people with high cholesterol, a major cause of heart problems. It aims to assist those with abnormal cholesterol levels by enhancing access to care and developing a treatment model aligned with doctors' guidelines. The trial suits individuals with high LDL cholesterol (a type of bad cholesterol), a family history of heart disease, or previous heart issues. Participants will receive supportive care, a comprehensive approach to managing health, with a focus on improving overall well-being. As an unphased trial, joining offers a unique opportunity to contribute to innovative research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this supportive care is safe for high cholesterol patients?

Research has shown that supportive care for high cholesterol usually helps patients manage their lifestyle. This care can include advice on diet, exercise, and medication. Since this trial is marked as "Not Applicable" for phase, it likely doesn't involve new drugs or invasive treatments. Instead, it focuses on optimizing existing resources and guidelines.

Supportive care here is generally easy to manage because it uses non-invasive methods. These methods aim to improve overall health without introducing new risks. No specific safety concerns or side effects have been noted for supportive care in this context, suggesting it is a safe way to manage high cholesterol.

Why are researchers excited about this trial?

Researchers are excited about supportive care for high cholesterol because it offers a new approach to managing the condition. Unlike traditional treatments, which often rely on medications like statins to lower LDL-C (bad cholesterol) levels, supportive care focuses on holistic strategies that include lifestyle changes, dietary adjustments, and other non-pharmaceutical interventions. This method aims to empower patients to take control of their cholesterol levels without the potential side effects of medication, potentially improving overall well-being and quality of life.

What evidence suggests that supportive care is effective for high cholesterol?

Research shows that managing high cholesterol is crucial for reducing heart disease risk. This trial evaluates supportive care, including diet and exercise changes, for its effectiveness in lowering cholesterol levels. Studies have proven that reducing "bad" cholesterol (LDL-C) significantly lowers the risk of heart attacks and strokes. By focusing on personalized care and close monitoring, patients can better control their cholesterol. This approach aims to identify high-risk patients early and equip them with the tools needed to improve heart health.

Who Is on the Research Team?

Robert D Fishberg, MD

Principal Investigator

Atlantic Health System

Are You a Good Fit for This Trial?

This trial is for individuals with high cholesterol or related lipid disorders. It's aimed at those who could benefit from improved treatment access both at their primary care and specialty levels. The goal is to identify high-risk patients using electronic health records and work closely with their primary doctors for better management.

Inclusion Criteria

Consenting individuals

A close family member has had coronary artery disease.

LDL-C ≥160 mg/dL

Exclusion Criteria

Individuals who are pregnant

Individuals who do not consent

Individuals who are incarcerated

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive comprehensive medical management to reduce LDL-C levels

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Supportive care

Trial Overview The program isn't testing a specific drug, but rather a new approach to managing high cholesterol by optimizing the use of resources in medical practices. This includes following guidelines more closely and possibly integrating new strategies into patient care.

How Is the Trial Designed?

Group I: LDL-C Experimental Treatment 1 Intervention

Most recent LDL-C result

Who Is Running the Clinical Trial?

Atlantic Health System

Lead Sponsor

Trials

58

Recruited

9,400+

Regeneron Pharmaceuticals

Industry Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Published Research Related to This Trial

Heart and vascular diseases are the leading cause of death globally, highlighting the importance of effective lipid-lowering strategies for high-risk patients.

Nurse-centered case management programs have proven effective in helping high-risk patients adhere to lifestyle changes and medication, leading to better achievement of low-density lipoprotein cholesterol goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lipid-lowering therapy today: treating the high-risk cardiovascular patient. Berra, K.[2021]

Preventable adverse drug events (pADEs) occur at a median rate of 5.6 per 1000 person-months in ambulatory care, with cardiovascular drugs, analgesics, and hypoglycemic agents accounting for the majority of these events.

Many pADEs lead to hospitalization, highlighting the need for quality improvement programs that focus on reducing prescribing and monitoring errors, particularly for high-risk medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of the incidence and characteristics of preventable adverse drug events in ambulatory care. Thomsen, LA., Winterstein, AG., Søndergaard, B., et al.[2022]

An internet-based reporting system was developed to help healthcare professionals, particularly pharmacists, report dietary supplement-related adverse events, addressing the issue of underreporting due to lack of awareness and time constraints.

The system not only facilitated the collection of DS-related events but also provided educational resources, which increased engagement and awareness among healthcare professionals regarding the safety of dietary supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Collecting and sharing information about dietary supplements and functional foods among healthcare professionals using internet-based system]. Asahina, Y., Hori, S., Sawada, Y.[2019]

In a study analyzing 2557 patient records, 72.7% of do-not-do recommendations (DNDs) were ignored, leading to 69 avoidable adverse events (AAEs) in 1307 patients, indicating a significant risk associated with disregarding these guidelines.

Most AAEs were minor and temporary, with a higher occurrence in older adults (5.7% in patients aged 65 and older), highlighting the potential safety risks of low-value medical practices in primary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Avoidable Adverse Events Related to Ignoring the Do-Not-Do Recommendations: A Retrospective Cohort Study Conducted in the Spanish Primary Care Setting. Mira, JJ., Carrillo, I., Pérez-Pérez, P., et al.[2023]

A study involving 31 health professionals revealed significant gaps in knowledge and fear of punishment as major barriers to effectively reporting adverse events in a teaching hospital.

Improving communication and educational practices between leaders and healthcare professionals is essential to enhance the reporting of adverse events, which is crucial for patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The practice of reporting adverse events in a teaching hospital. Siman, AG., Cunha, SGS., Brito, MJM.[2019]

Citations