Actively Recruiting

Phase Not Applicable
Age: 18Years - 120Years
All Genders
ID06439654

Atlantic Lipid Lowering Treatment Optimization Program (ALLTOP): A Comprehensive Approach to the Treatment of Familial Hypercholesterolemia and Complex Dyslipidemias

Led by Atlantic Health System · Updated on 2025-08-03

250

Participants Needed

2

Research Sites

30 weeks

Total Duration

On this page

Sponsors

A

Atlantic Health System

Lead Sponsor

R

Regeneron Pharmaceuticals

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying familial hypercholesterolemia and related lipid disorders to improve treatment and reduce cardiovascular risks. The study aims to enhance lipid disorder management by partnering with primary care providers and using electronic health records to identify high-risk patients. The goal is to develop a prevention model that integrates treatment guidelines at the practice level, focusing on lowering LDL cholesterol levels in affected individuals. Participants with high LDL-C levels, especially those with familial hypercholesterolemia or related conditions, will receive supportive care through a comprehensive outreach approach. This includes database screening, secure communication with healthcare providers, genetic testing encouragement, education, medication adherence support, routine lab testing, specialist referrals, and follow-up visits either in person or virtually. Additional consultations with pharmacists, nutritionists, genetic counselors, or specialists may be provided to manage coexisting conditions. During the study, patients' LDL-C levels will be monitored, with the primary measure being the proportion maintaining LDL-C below 100 mg/dL six months after enrollment. Secondary outcomes include achieving LDL-C levels below 75 and 55 mg/dL. The study involves ongoing medical management, routine lab tests, and access to integrated care resources, aiming to improve lipid control and reduce cardiovascular risks over time.

CONDITIONS

Brief Title

Atlantic Lipid Lowering Treatment Optimization Program

Who Can Participate

Age: 18Years - 120Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • LDL-C level of 160 mg/dL or higher
  • Untreated LDL-C of 190 mg/dL or higher with family history of coronary artery disease
  • History of prior heart attack without optimized lipid-lowering therapy
  • Family history of coronary artery disease in a first-degree relative
  • Personal history of coronary artery disease
  • Untreated triglycerides greater than 500
  • Elevated Lp(a) and/or high calcium scores
  • Individuals who provide consent to participate
Not Eligible

You will not qualify if you...

  • Individuals who are pregnant
  • Individuals who are incarcerated
  • Individuals with a terminal illness
  • Individuals who do not consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or virtual)

Supportive Care

Duration - 6 months

Participants receive enhanced supportive care involving outreach, genetic testing encouragement, education, medical management, specialist referrals, and routine follow-up either in person or virtually to manage familial hypercholesterolemia and complex dyslipidemias.

Routine in-person or virtual follow-up visits during 6 months

Trial Site Locations

Total: 2 locations

1

Atlantic Medical Group

Clark, New Jersey, United States, 07066

Not Yet Recruiting

2

Atlantic Medical Group

Springfield, New Jersey, United States, 07081

Actively Recruiting

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Research Team

R

Robert D Fishberg, MD

J

Jeffrey N Feldman, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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Frequently Asked Questions

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Published Research Related To This Trial

2022 ACC Expert Consensus Decision Pathway on the Role of Nonstatin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk: A Report of the American College of Cardiology Solution Set Oversight Committee.

Writing Committee, Donald M Lloyd-Jones, Pamela B Morris...

https://pubmed.ncbi.nlm.nih.gov/36031461

Diagnostic Yield and Clinical Utility of Sequencing Familial Hypercholesterolemia Genes in Patients With Severe Hypercholesterolemia.

Amit V Khera, Hong-Hee Won, Gina M Peloso...

https://pubmed.ncbi.nlm.nih.gov/27050191

Health disparities among adult patients with a phenotypic diagnosis of familial hypercholesterolemia in the CASCADE-FH™ patient registry.

Stephen M Amrock, P Barton Duell, Thomas Knickelbine...

https://pubmed.ncbi.nlm.nih.gov/29080546

ODYSSEY FH I and FH II: 78 week results with alirocumab treatment in 735 patients with heterozygous familial hypercholesterolaemia.

John J P Kastelein, Henry N Ginsberg, Gisle Langslet...

https://pubmed.ncbi.nlm.nih.gov/26330422