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Anti-metabolites

Statins + Lifestyle Counseling for High Cholesterol (EMERALD RCT Trial)

Phase 2

Recruiting

Led By Nick Ashburn

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 40-75 Years

10-year Atherosclerotic Cardiovascular Disease (ASCVD) Risk ≥7.5% or Known Diabetes or Known ASCVD: Myocardial Infarction, Unstable Angina, Percutaneous Coronary Intervention, Coronary Artery Bypass Graft, Stroke, Transient Ischemic Attack, Peripheral Artery Disease

Must not have

ST-Segment Elevation Myocardial Infarction (STEMI) Activation

On a Lipid Lowering Agent (Statin, PCSK9 Inhibitor, Bempedoic Acid, Ezetimibe, Inclisiran, etc.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up index ed encounter through 180 days (+/- 15 days)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to assess a program called EMERALD that provides cardiovascular care to patients in the emergency department who are at risk of heart disease. The goal is to see if this program can help lower

Who is the study for?

This trial is for adults aged 40-75 who are being checked for heart issues in the ER and have a high risk of heart disease or existing conditions like diabetes or past heart events. It's not for those with severe ongoing heart attacks, on other cholesterol meds, with life expectancy under a year, unstable vitals, non-English speakers, pregnant women, prisoners, liver cirrhosis patients, statin intolerance or very poor kidney function.

What is being tested?

The EMERALD study tests if starting statins (rosuvastatin) and healthy lifestyle advice in the ER can lower bad cholesterol levels in at-risk patients not already getting this care. Patients will also get follow-up appointments to check progress and adherence.

What are the potential side effects?

Possible side effects from rosuvastatin include muscle pain or weakness, liver problems signaled by yellowing skin/eyes or dark urine; digestive issues like nausea; headache; increased blood sugar levels which could lead to diabetes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 40 and 75 years old.

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I have a high heart disease risk, diabetes, or a history of heart issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a type of heart attack known as STEMI.

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I am currently taking medication to lower my cholesterol.

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I have liver cirrhosis.

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My kidney function is very low.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ index ed encounter through 180 days (+/- 15 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~index ed encounter through 180 days (+/- 15 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and index ed encounter through 180 days (+/- 15 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent change in low-density lipoprotein cholesterol (LDL-C) at 30 days

Secondary study objectives

Percent change in LDL-C at 180 days.

Percent change in non high-density lipoprotein cholesterol (non-HDL-C) at 30 days

Percent change in non-HDL-C at 180 days

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) armExperimental Treatment3 Interventions

In the EMERALD arm, care will vary by risk level: (1) patients with known atherosclerotic cardiovascular disease (ASCVD) will qualify for a high-intensity statin (rosuvastatin 40 mg daily) and referral to cardiology for secondary prevention, (2) patients with low-density lipoprotein cholesterol (LDL-C) ≥190 mg/dL will receive a high-intensity statin and a cardiology referral for primary prevention, and (3) for the remaining patients, Emergency Department providers will calculate 10-year ASCVD risk using the Pooled Cohort Equations. These patients will be categorized as (3A) high risk patients (10-year risk ≥20%) who will receive a high-intensity statin and a cardiology referral and (3B) moderate risk patients (10-year risk ≥7.5% but \<20% or those with known diabetes and 10-year risk \<20%) who will receive a moderate-intensity statin (rosuvastatin 10 mg daily) and a primary care referral. EMERALD patients will also receive healthy lifestyle counseling.

Group II: Usual Care ArmActive Control2 Interventions

Patients in the usual care arm will receive the current standard of care, which consists of primary care referral and no Emergency Department statin prescription. They will also receive healthy lifestyle counseling.

0 / 6Eligibility criteria met