← Back to Search

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

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
Select...
I am between 40 and 75 years old.
Select...
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:
Select...
I have had a type of heart attack known as STEMI.
Select...
I am currently taking medication to lower my cholesterol.
Select...
I have liver cirrhosis.
Select...
My kidney function is very low.

Timeline

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

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.

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,266 Previous Clinical Trials
1,013,577 Total Patients Enrolled
1 Trials studying Lipid Disorders
22 Patients Enrolled for Lipid Disorders
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,889 Previous Clinical Trials
47,834,077 Total Patients Enrolled
2 Trials studying Lipid Disorders
230 Patients Enrolled for Lipid Disorders
National Institutes of Health (NIH)NIH
2,765 Previous Clinical Trials
8,133,381 Total Patients Enrolled
3 Trials studying Lipid Disorders
90 Patients Enrolled for Lipid Disorders
~87 spots leftby Nov 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top