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PCSK9 Inhibitor

Treatment Arm for Heart Transplant

Phase 2
Waitlist Available
Led By Douglas A Stoller, MD, PhD
Research Sponsored by University of Nebraska
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 12 weeks
Awards & highlights

Study Summary

This trialis testing if a drug can lower cholesterol in heart transplant patients with CAV. It will measure if it works after 12 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To measure the effect of evolocumab on serum LDL as measured in mL/dL after 12 weeks of therapy in heart transplant patients.

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
Patients who will receive the study drug.
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?

University of NebraskaLead Sponsor
536 Previous Clinical Trials
1,143,896 Total Patients Enrolled
AmgenIndustry Sponsor
1,367 Previous Clinical Trials
1,386,227 Total Patients Enrolled
Douglas A Stoller, MD, PhDPrincipal InvestigatorUniversity of Nebraska

Frequently Asked Questions

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

Am I able to participate in this experiment?

"Patients between the ages of 19 to 80 with a cardiac transplant are qualified for this medical trial, which is currently seeking 26 participants."

Answered by AI

What is the current participation rate in this trial?

"At this time, the clinical trial is not accepting applicants. The study was initially published on July 15th 2019 and last revised on November 4th 2022. If you are exploring alternate studies, 10 cardiac transplant trials and 22 Evolocumab (Repatha) studies are currently seeking participants."

Answered by AI

Has the FDA sanctioned Evolocumab (Repatha) for public use?

"Our experts at Power have assigned a score of 2 to Evolocumab (Repatha) as it is currently undergoing Phase 2 trials, indicating that there was evidence pointing towards safety but no data yet confirming its efficacy."

Answered by AI

Are there vacancies available for volunteers to join this experiment?

"Unfortunately, this clinical trial is not currently recruiting. The initial advertisement was posted on July 15th 2019 and the listing last updated on November 4th 2022. However, 10 studies are available for those with cardiac transplants while 22 trials admit participants to test Evolocumab (Repatha)."

Answered by AI

Is this research an unprecedented exploration of its kind?

"Evolocumab (Repatha) has been under investigation since 2018, when Hoffmann-La Roche initiated the first clinical trial. After 435 people participated in that Phase 1 & 2 study, it received drug approval and is now included in 22 ongoing trials across 240 distinct cities and 35 nations."

Answered by AI

Is the upper age restriction for this research encompassing those aged 55 and above?

"This particular trial has a minimum age requirement of 19 and an upper limit of 80 for those wishing to participate."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Impact of Evolocumab in Cardiac Transplant Patients With CAV
Douglas Stoller 2019. "Impact of Evolocumab in Cardiac Transplant Patients With CAV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03944577.
~5 spots leftby Apr 2025
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