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PCSK-9 Inhibitor

Evolocumab for Coronary Heart Disease (EMPOWER Trial)

Phase 4
Recruiting
Led By Marcelo Di Carli, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stable coronary artery disease (without plan to undergo revascularization before randomization) defined as one or more of the following:
- CAC >100 + >1 ASCVD risk factor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change (from baseline) in tpd, as measured by pet imaging at 52 weeks after initiation of evolocumab therapy.
Awards & highlights

EMPOWER Trial Summary

This trialstudies how a drug to lower cholesterol affects blood flow in people with stable heart disease. 35 people will get imaging scans before and after taking the drug.

Who is the study for?
This trial is for adults over 50 (men) or 55 (women) with stable coronary artery disease and LDL cholesterol ≥70 mg/dL. They must not be planning revascularization soon, have been on a steady statin dose for 3+ months if applicable, and meet certain criteria indicating heart issues. Excluded are pregnant/breastfeeding individuals, those with severe heart conditions, kidney failure, contraindications to vasodilators, recent major cardiac events or procedures, specific genetic disorders affecting cholesterol levels, severe heart failure or angina.Check my eligibility
What is being tested?
The study tests the effect of Evolocumab on blood flow in coronary arteries using PET scans and CCTA imaging before and after a year of treatment. It's an open-label pilot study where all participants receive the drug; there's also a control group without the drug to compare changes in myocardial blood flow and plaque volume.See study design
What are the potential side effects?
While side effects specific to Evolocumab aren't listed here, common ones include symptoms like flu-like illness, reactions at injection site such as redness or pain; rare but serious side effects can involve muscle-related problems and immune-mediated reactions.

EMPOWER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My heart disease is stable and I don't plan to have surgery for it soon.
Select...
My coronary artery calcium score is over 100 and I have more than one risk factor for heart disease.
Select...
I am a man over 50 or a woman over 55.

EMPOWER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change (from baseline) in global cfr, as measured by pet imaging at 52 weeks after initiation of evolocumab therapy.
This trial's timeline: 3 weeks for screening, Varies for treatment, and change (from baseline) in global cfr, as measured by pet imaging at 52 weeks after initiation of evolocumab therapy. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Coronary Flow Reserve
Stress Myocardial Blood Flow (MBF)
Secondary outcome measures
Total Perfusion Deficit (TPD)

Side effects data

From 2020 Phase 4 trial • 259 Patients • NCT03096288
5%
chest pain
5%
gastrointestinal bleeding
100%
80%
60%
40%
20%
0%
Study treatment Arm
HPR - Evolocumab
HPR - Placebo
NPR - Evolocumab
NPR - Placebo

EMPOWER Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: EvolocumabExperimental Treatment1 Intervention
Informed consent will be obtained from study participants willing to participate in EMPOWER. Study participants will then undergo the baseline rest/stress cardiac PET scan along with CCTA. The final PET scan and CCTA will occur at 12 months after the intervention.
Group II: ControlActive Control1 Intervention
Informed consent will be obtained from study participants willing to participate in EMPOWER. Study participants will then undergo the baseline rest/stress cardiac PET scan along with CCTA. The final PET scan and CCTA will occur at 12 months after the baseline.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Evolocumab
2011
Completed Phase 4
~13010

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,618 Previous Clinical Trials
11,471,331 Total Patients Enrolled
18 Trials studying Coronary Disease
176,975 Patients Enrolled for Coronary Disease
Marcelo Di Carli, MDPrincipal InvestigatorBrigham and Women's Hospital
3 Previous Clinical Trials
72 Total Patients Enrolled
1 Trials studying Coronary Disease
47 Patients Enrolled for Coronary Disease

Media Library

Evolocumab (PCSK-9 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05152888 — Phase 4
Coronary Disease Research Study Groups: Evolocumab, Control
Coronary Disease Clinical Trial 2023: Evolocumab Highlights & Side Effects. Trial Name: NCT05152888 — Phase 4
Evolocumab (PCSK-9 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05152888 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned the use of Evolocumab?

"As this medical intervention has been approved, our team at Power judged the safety of Evolocumab to be a 3 on a scale from 1-3."

Answered by AI

Does this experimental program accept individuals older than 45?

"This investigation requires that patients be between 50 and 90 years old to qualify for participation. There are also 8 clinical trials available for minors, while elderly individuals have access to 254 separate studies."

Answered by AI

Does this research initiative mark an unprecedented milestone?

"As of now, 22 trials for the drug evolocumab are active and spread across 240 cities in 35 nations. The first clinical trial concerning this medication was conducted by Hoffmann-La Roche back in 2018 with a participant pool of 435 people who saw it through Phase 1 & 2 FDA approval stages. Out of the 50 studies that have been completed since then, none has surpassed its efficacy or safety profile yet."

Answered by AI

How many participants have been enrolled in this experiment?

"Correct. The clinical trial is still recruiting, as can be discerned from the information hosted on clinicaltrials.gov. This medical study was originally posted on March 3rd 2022 and revised for the last time on November 1st 2022; 35 participants are needed at one single site."

Answered by AI

Who are the ideal candidates to participate in this experimental program?

"This clinical trial is interested in accepting 35 patients with coronary heart disease, aged between 50 and 90 years old."

Answered by AI

Is there still an opportunity for participants to join this experiment?

"Affirmative. The clinicaltrials.gov entry for this medical trial points out that it is currently making attempts to enroll participants, having been first posted on March 3rd 2022 and last updated November 1st 2022. A total of 35 people will be recruited from one site in particular."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The Impact of Pcsk-9 Inhibition on PET CFR in Patients at High CV Risk
Marcelo F. Di Carli, MD, FACC 2022. "The Impact of Pcsk-9 Inhibition on PET CFR in Patients at High CV Risk". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05152888.
~21 spots leftby Dec 2025
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