Statins + Lifestyle Counseling for High Cholesterol
(EMERALD RCT Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Wake Forest University Health Sciences
Must not be taking: Statins, PCSK9 inhibitors
Disqualifiers: STEMI, ESRD, Liver cirrhosis, others
No Placebo Group
Prior Safety Data
Approved in 6 Jurisdictions
Trial Summary
What is the purpose of this trial?Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) is a protocolized intervention based on American College of Cardiology/American Heart Association and US Preventive Services Task Force guidelines designed to initiate preventive cardiovascular care for emergency department patients being evaluated for acute coronary syndrome. The overarching goals of this proposal are to (1) determine the efficacy of EMERALD at lowering low-density lipoprotein cholesterol (LDL-C) and non high-density lipoprotein cholesterol (non-HDL-C) among at-risk Emergency Department (ED) patients who are not already receiving guideline-directed outpatient preventive care and (2) inform our understanding of patient adherence and determinants of implementation for ED-based cardiovascular disease prevention strategies.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are already on a lipid-lowering agent like statins or similar drugs.
What data supports the effectiveness of the drug for high cholesterol?
Research shows that statins, including atorvastatin, simvastatin, pravastatin, and others, are effective in lowering LDL cholesterol levels, which can reduce the risk of heart disease. Studies have demonstrated that these drugs can significantly decrease cholesterol levels and improve heart health outcomes.
12345Are statins safe for humans?
Statins, which include drugs like atorvastatin, simvastatin, and others, are generally well tolerated and have been used by millions of people. However, they can sometimes cause side effects like muscle pain, liver issues, and sleep disturbances. It's important to discuss any concerns with a healthcare provider.
12678How is the drug Statins + Lifestyle Counseling unique for treating high cholesterol?
The combination of statins (cholesterol-lowering drugs) with lifestyle counseling is unique because it not only targets cholesterol levels through medication but also encourages healthy lifestyle changes, which can enhance the overall effectiveness of treatment and improve cardiovascular health.
135910Eligibility Criteria
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.Inclusion Criteria
Evaluation for Acute Coronary Syndrome
I am between 40 and 75 years old.
I have a high heart disease risk, diabetes, or a history of heart issues.
Exclusion Criteria
I have had a type of heart attack known as STEMI.
ST Depression >1 mm in Contiguous Leads
Anticipated Hospitalization or Placement into an Observation Protocol
+12 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive a lipid panel test, statin prescription based on risk level, and healthy lifestyle counseling
30 days
1 visit (in-person)
Follow-up
Participants are monitored for changes in LDL-C and non-HDL-C levels and adherence to statin therapy
180 days
2 visits (in-person)
Qualitative Assessment
Qualitative interviews to determine facilitators and barriers to the EMERALD program
30 days
Participant Groups
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.
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.
Statin is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:
🇺🇸 Approved in United States as Statins for:
- Hypercholesterolemia
- Hypertriglyceridemia
- Cardiovascular disease prevention
🇪🇺 Approved in European Union as Statins for:
- Hypercholesterolemia
- Hypertriglyceridemia
- Cardiovascular disease prevention
🇨🇦 Approved in Canada as Statins for:
- Hypercholesterolemia
- Hypertriglyceridemia
- Cardiovascular disease prevention
🇯🇵 Approved in Japan as Statins for:
- Hypercholesterolemia
- Hypertriglyceridemia
- Cardiovascular disease prevention
🇨🇳 Approved in China as Statins for:
- Hypercholesterolemia
- Hypertriglyceridemia
- Cardiovascular disease prevention
🇨🇭 Approved in Switzerland as Statins for:
- Hypercholesterolemia
- Hypertriglyceridemia
- Cardiovascular disease prevention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Wake Forest University Health SciencesWinston-Salem, NC
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Who Is Running the Clinical Trial?
Wake Forest University Health SciencesLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
National Institutes of Health (NIH)Collaborator
References
Comparative evaluation of the safety and efficacy of HMG-CoA reductase inhibitor monotherapy in the treatment of primary hypercholesterolemia. [2018]To evaluate the comparative efficacy and safety of the 4 currently available hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors, fluvastatin, lovastatin, pravastatin, and simvastatin, in the treatment of primary hypercholesterolemia.
A review of clinical trials comparing HMG-CoA reductase inhibitors. [2007]Four drugs that act as specific inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase--lovastatin, pravastatin, simvastatin, and, most recently, fluvastatin--have been approved by regulatory authorities throughout the world. In the present review, we have critically assessed the comparative hypocholesterolemic effects of these four drugs based on direct comparative studies, which were randomized, double-blind, and included more than 25 patients per treatment group. All studies were conducted in patients with primary hypercholesterolemia and the major end point of efficacy was reduction in the plasma concentrations of low-density lipoprotein (LDL)-cholesterol. Eight comparative trials have evaluated the efficacy and safety of lovastatin, simvastatin, or pravastatin, and one recently completed trial has compared lovastatin and fluvastatin. These trials confirm the log-linear dose response curves for all four of these drugs but indicate that on a milligram-for-milligram basis, lovastatin and pravastatin are approximately equipotent, whereas simvastatin is at least twice as effective per milligram of drug administered as lovastatin and pravastatin. Lovastatin at doses of 20 and 40 mg/d was of similar efficacy to fluvastatin at doses of 40 and 80 mg/d and would suggest that on a milligram-for-milligram basis, fluvastatin is half as potent as lovastatin. The side-effect profiles of all four drugs appeared similar, and earlier reports that suggested a higher incidence of sleep disorders in patients treated with the more lipophilic drugs, lovastatin and simvastatin, as compared with pravastatin, are not supported by more recent, controlled clinical trials. We conclude that although the currently available HMG-CoA reductase inhibitors differ in their relative hypolipidemic effects, as a class they constitute the most effective agents available to maximally reduce elevated concentrations of LDL-cholesterol.
An overview of the clinical safety profile of atorvastatin (lipitor), a new HMG-CoA reductase inhibitor. [2019]Statins (3-hydroxy-3-methylglutaryl-coenzyme A [HMG-CoA] reductase inhibitors) have been used for a decade to lower low-density lipoprotein (LDL) cholesterol levels and to improve cardiovascular disease and clinical outcomes.
Planned, ongoing and recently completed clinical trials for atherosclerosis prevention and regression: an update. [2019]Recent landmark studies using hydroxy-methyl-glutaryl-Co-enzyme A reductase inhibitors (HMG-CoA reductase inhibitors or statins), specifically, pravastatin and simvastatin, have led to dramatic changes in medical practice. These clinical trials have demonstrated that clinicians can impact coronary morbidity and mortality in primary (pravastatin) and secondary (pravastatin, simvastatin) prevention settings, including post-infarct patients with 'normal' cholesterol levels (pravastatin). The clinical benefit can be seen irrespective of risk factors at baseline and in women, the elderly and diabetics.
Efficacy of 3-hydroxy-3-methylglutaryl coenzyme a reductase inhibitors in the treatment of patients with hypercholesterolemia: a meta-analysis of clinical trials. [2019]Recent studies have documented the long-term impact of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors on mortality and morbidity related to coronary heart disease, establishing the link between lowering cholesterol levels and reducing cardiac events. Our study was a comparative literature review and meta-analysis of the efficacy of four HMG-CoA reductase inhibitors-fluvastatin, lovastatin, pravastatin, and simvastatin-used in the treatment of patients with hypercholesterolemia. The data sources for our meta-analysis of the efficacy of these cholesterol-lowering agents were 52 randomized, double-masked clinical trials with at least 25 patients per treatment arm. The results showed all four agents to be effective in reducing blood cholesterol levels. We computed summary efficacy estimates for all published dose strengths for the four agents. Fluvastatin 20 mg/d reduced low-density lipoprotein cholesterol (LDL-C) levels by 21.0% and total cholesterol (total-C) levels by 16.4%; fluvastatin 40 mg/d reduced these levels by 23.1% and 17.7%, respectively. Lovastatin 20 mg/d reduced LDL-C levels by 24.9% and total-C levels by 17.7%; lovastatin 80 mg/d reduced these levels by 39.8% and 29.2%, respectively. Pravastatin 10 mg/d reduced LDL-C levels by 19.3% and total-C levels by 14.0%; pravastatin 80 mg/d reduced these levels by 37.7% and 28.7%, respectively. Simvastatin 2.5 mg/d reduced LDL-C levels by 22.9% and total-C levels by 15.7%; simvastatin 40 mg/d reduced these levels by 40.7% and 29.7%, respectively. The results of our meta-analysis can be used in conjunction with treatment objectives and comparative cost-effectiveness data for these agents to decide appropriate therapeutic alternatives for individual patients.
Comparison of different HMG-CoA reductase inhibitors. [2018]The HMG-CoA reductase inhibitors have been shown to cause marked reduction of cholesterol and offer a new and effective approach to treatment of hyperlipoproteinemia. Three agents, pravastatin (P), lovastatin (L) and simvastatin (S), have been studied with reference to long-term lipid-lowering effect, tolerance and clinical safety. Following a dietary lead-in period of at least 6 weeks in every case, patients with primary hypercholesterolemia were enrolled from participants of short-term controlled studies which after completion were extended as open studies. Treatment was administered over 6 months with 20 mg S (84 patients), L (42 patients) or P (23 patients) twice daily. Total cholesterol was decreased with S by 30.2% of basal, with L by 25.5%, and with P by 28.2%. The decrease in apolipoprotein B was 28.4%, of basal, with S 16.4% and in P 19.2%. Triglycerides were lowered by 19.6% of basal with S by 17.4%, with L, and by 6.4% with HDL-cholesterol increased in the S group by 23% of basal, by 9.7% in the L group, and by 8.0% in the P group. No serious clinical or laboratory abnormalities were observed. In the S group headache (3.6% of patients), abdominal discomfort (2.4%), sleeping disturbances (3.6%), and muscle pain (2.4%) were reported. In the L group headache (7.1%), abdominal discomfort (4.8%), sleep disorders (4.8%), and muscle pain (4.8%) were observed. In the P group one patient complained of abdominal discomfort (8.7%) and one of sleep disorders (8.7%). Increases in CPK were observed in the S group (4.8% of patients) and in the L group (11.9%).(ABSTRACT TRUNCATED AT 250 WORDS)
Statin safety: an overview and assessment of the data--2005. [2022]The 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, or statin drugs, have been studied in numerous controlled human research trials involving hundreds of thousands of study participants. Statins have been prescribed for millions of patients. Based on this vast research and clinical experience, statins have been shown to improve lipid blood levels and reduce atherosclerotic coronary artery disease (CAD) risk, resulting in reduced CAD morbidity and mortality, and in several studies, reduced overall ("all-cause") mortality. From a safety perspective, both research trial evidence and clinical practice experience have demonstrated that statins are generally well tolerated. However, as with all pharmaceuticals, safety considerations exist with both monotherapy and combination statin therapy, mainly involving potential adverse effects on muscle, liver, kidney, and the nervous system. The evidence supporting statin-related potential adverse experiences on these organ systems is sometimes strong and based on clear clinical trial evidence (such as the increased risk of muscle enzyme elevation with higher statin doses). The evidence is at other times more speculative, being based on case reports and inconclusive clinical trial data (such as possible favorable or unfavorable effects of statins on cognition). Because the use of statins is so widespread, it is useful for the clinician to understand statin safety issues and the level of available evidence supporting the contention that various adverse effects are caused by statins. This review presents an assessment of statin safety based on an overview of the current statin safety data and their clinical implications.
Statin-associated muscular and renal adverse events: data mining of the public version of the FDA adverse event reporting system. [2021]Adverse event reports (AERs) submitted to the US Food and Drug Administration (FDA) were reviewed to assess the muscular and renal adverse events induced by the administration of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) and to attempt to determine the rank-order of the association.
[HMG-CoA reductase inhibitors: a brief review of their pharmacological properties and clinical efficacy in cardiovascular disease]. [2013]The results of recently published studies on primary and secondary prevention of coronary heart disease with HMG-CoA reductase inhibitors--statins--support their use in patients with primary hypercholesterolaemia or mixed hyperlipidaemia, with or without atherosclerotic vascular disease. From a pharmacological point of view, statins inhibit HMG-CoA reductase, reduce the endogenous synthesis of cholesterol and increase the apoB/apoE lipoprotein clearance from plasma. Recent studies confirm that HMG-CoA reductase inhibitors may also decrease hepatic production of VLDL and LDL-cholesterol. However, they have different pharmacokinetic properties and variable effectiveness with potential clinical implications. These drugs are generally well tolerated with a similar profile of adverse effects (gastrointestinal effects, hepatic dysfunction and myopathy). The knowledge of their pharmacodynamic and pharmacokinetic properties can lead to a rational use and greater understanding of their potential benefits.
Efficacy and safety of rosuvastatin and atorvastatin in patients with hypercholesterolemia and a high risk of coronary heart disease: a randomized, controlled trial. [2018]This double-blind, multicenter, randomized trial compared rosuvastatin and atorvastatin for reducing low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia and a high risk of coronary heart disease.