Evolocumab for Atherosclerosis

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Atherosclerosis+2 MoreEvolocumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether evolocumab, when added to statin therapy, can improve the health of veins used in bypass surgery.

Eligible Conditions
  • Atherosclerosis
  • Coronary Artery Bypass Surgery
  • Venous Occlusion

Treatment Effectiveness

Effectiveness Progress

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

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 24 months post CABG

24 months post CABG
Composite rate of fatal and non-fatal myocardial infarction, fatal and non-fatal stroke, cardiovascular death, coronary heart disease death, repeat coronary revascularization
Percentage of patients free of vein graft disease at 24 months.
Rate of all-cause mortality.
Rate of cardiovascular death.
Rate of coronary heart disease death.
Rate of fatal and non-fatal myocardial infarction.
Rate of fatal and non-fatal stroke.
Rate of repeat coronary revascularization.
Rate of total vein graft patency at 24 months.
Saphenous vein graft disease rate (VGDR)
The percentage of vein grafts which are totally (100%) occluded grafts.
The proportion of patients with at least 1 vein graft totally (100%) occluded.
Vein graft plaque volume.

Trial Safety

Safety Progress

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

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

2 Treatment Groups

Evolocumab Treatment
1 of 2
Placebo Treatment
1 of 2

Experimental Treatment

Non-Treatment Group

766 Total Participants · 2 Treatment Groups

Primary Treatment: Evolocumab · Has Placebo Group · Phase 4

Evolocumab Treatment
Drug
Experimental Group · 1 Intervention: Evolocumab · Intervention Types: Drug
Placebo Treatment
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
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: 24 months post cabg

Who is running the clinical trial?

Applied Health Research CentreOTHER
21 Previous Clinical Trials
70,867 Total Patients Enrolled
Unity Health TorontoLead Sponsor
494 Previous Clinical Trials
375,124 Total Patients Enrolled
1 Trials studying Atherosclerosis
123 Patients Enrolled for Atherosclerosis
Subodh Verma, MDPrincipal InvestigatorUnity Health Toronto
4 Previous Clinical Trials
3,175 Total Patients Enrolled
David Mazer, MDPrincipal InvestigatorUnity Health Toronto
9 Previous Clinical Trials
7,402 Total Patients Enrolled
Lawrence Leiter, MDStudy ChairUnity Health Toronto
1 Previous Clinical Trials
2,500 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had a CABG procedure within the past 21 days, or are planning one within the next 60 days.