Evolocumab for Stable Coronary Disease

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Stable Coronary DiseaseEvolocumab - Drug
Eligibility
50 - 90
All Sexes
What conditions do you have?
Select

Study Summary

The study protocol is a single-arm, open label pilot study designed to evaluate the impact of PCSK-9 inhibition on coronary blood flow in patients with stable coronary artery disease. Patients with stable coronary artery disease will be recruited from the BWH Cardiovascular Medicine clinic and/or from the BWH Nuclear Cardiology Laboratory. A target sample size of 35 participants will undergo imaging with N-13 ammonia or Rubidium-82 positron emission tomography (PET) and coronary computed tomography angiography (CCTA) before and after 12 months of PCSK-9 inhibition with Evolocumab to assess changes in myocardial blood flow, plaque volume, and vascular endothelial function.

Eligible Conditions
  • Stable Coronary Disease

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

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rest/ stress imaging day 2
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Coronary Artery Calcium Screening and Statin Treatment

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: Change (from baseline) in TPD, as measured by PET imaging at 52 weeks after initiation of Evolocumab therapy.

Week 52
Total Perfusion Deficit (TPD)
Week 52
Coronary Flow Reserve
Week 52
Stress Myocardial Blood Flow (MBF)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
rest/ stress imaging day 2
1
Evolocumab
1
Coronary Artery Calcium Screening and Statin Treatment

Side Effects for

HPR - Evolocumab
5%chest pain
5%gastrointestinal bleeding
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT03096288) in the HPR - Evolocumab ARM group. Side effects include: chest pain with 5%, gastrointestinal bleeding with 5%.

Trial Design

1 Treatment Group

Evolocumab
1 of 1

Experimental Treatment

35 Total Participants · 1 Treatment Group

Primary Treatment: Evolocumab · No Placebo Group · Phase 4

Evolocumab
Drug
Experimental Group · 1 Intervention: Evolocumab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Evolocumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: change (from baseline) in tpd, as measured by pet imaging at 52 weeks after initiation of evolocumab therapy.

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,480 Previous Clinical Trials
9,735,790 Total Patients Enrolled
Marcelo Di Carli, MDPrincipal InvestigatorBrigham and Women's Hospital
3 Previous Clinical Trials
72 Total Patients Enrolled

Eligibility Criteria

Age 50 - 90 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have low-density lipoprotein cholesterol (LDL-C) ≥ 70 mg/dL.
You have a positive nuclear perfusion imaging study.
You have ≥ 50% stenosis in ≥ 2 coronary vessels or diffuse atherosclerosis in a 3-vessel distribution.
You have a high coronary calcium score.
You have a CAC >100 or >1 ASCVD risk factor.
References

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