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PCSK9 Inhibitor

Evolocumab for Cardiovascular Disease

Phase 3

Waitlist Available

Led By Daniel S. Berman, MD

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (pre-treatment) and 18 months after of treatment

Awards & highlights

Study Summary

This trial will show whether evolocumab treatment reduces coronary plaque volume and improves plaque composition, which could help prevent future cardiac events.

Eligible Conditions

Cardiovascular Disease
High Cholesterol

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (pre-treatment) and 18 months after of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (pre-treatment) and 18 months after of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (pre-treatment) and 18 months after of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in noncalcified coronary artery plaque volume (NCPV)

Secondary outcome measures

Change in plaque composition (fibrous, fibrofatty, fatty, and calcified)

Side effects data

From 2020 Phase 4 trial • 259 Patients • NCT03096288

chest pain

gastrointestinal bleeding

100%

80%

60%

40%

20%

Study treatment Arm

HPR - Evolocumab

HPR - Placebo

NPR - Evolocumab

NPR - Placebo

Trial Design

1Treatment groups

Experimental Treatment

Group I: Evolocumab, F18-NaF PET, CCTAExperimental Treatment3 Interventions

Evolocumab self-administration for 18 months. Baseline (pre-treatment) and follow-up 18F-NaF PET and CCTA (possible beta-blocker and nitroglycerin, if medically safe).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CCTA

2019

Completed Phase 3

~1410

Evolocumab

2011

Completed Phase 4

~13010

18F-NaF PET

2019

Completed Phase 3

~60

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor

500 Previous Clinical Trials

164,808 Total Patients Enrolled

AmgenIndustry Sponsor

1,371 Previous Clinical Trials

1,378,082 Total Patients Enrolled

Daniel S. Berman, MD5.02 ReviewsPrincipal Investigator - Cedars-Sinai Medical Center

Cedars-Sinai Medical Center

1 Previous Clinical Trials

20 Total Patients Enrolled

Frequently Asked Questions

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

Has Evolocumab undergone FDA approval?

"There is both efficacy and safety data from previous clinical trials, so Evolocumab was given a score of 3."

Answered by AI

What is the precedence for this type of trial?

"There are 23 ongoing Evolocumab trials in 35 countries and 240 cities. The first trial was conducted in 2018 by Hoffmann-La Roche. That initial study had 435 participants and completed both Phase 1 & 2 of the drug approval process. Since 2018, an additional 53 studies have been completed."

Answered by AI

How many people are allowed to join this test group?

"At this moment in time, this study is not recruiting any more patients. It was originally posted on 3/19/2019 but the most recent update was on 7/20/2022. If you are interested in other trials, there are currently 512 trials actively looking for participants with lipidemia and 23 trials for Evolocumab actively recruiting participants."

Answered by AI

Are researchers still looking for participants in this trial?

"No, this study is not currently seeking patients. Although the trial was posted on March 19th, 2019 and updated as recently as July 20th, 2022, there are 535 other studies that are actively looking for patients right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Evolocumab on Coronary Artery Plaque Volume and Composition by CCTA and Microcalcification by F18-NaF PET

Daniel S. Berman 2019. "Effect of Evolocumab on Coronary Artery Plaque Volume and Composition by CCTA and Microcalcification by F18-NaF PET". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03689946.