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Trial Outcomes & Findings for Effect of Evolocumab on Coronary Endothelial Function (NCT NCT03500302)

NCT ID: NCT03500302

Last Updated: 2020-07-24

Results Overview

Coronary endothelial function will be assessed by the percent change in cross sectional coronary artery area (measured on MRI) from rest to isometric handgrip stress exercise at week 1 and week 6. The percent change from week 1 to week 6 is presented below.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

1 week and 6 weeks

Results posted on

2020-07-24

Participant Flow

Participant milestones

Participant milestones
Measure
Evolocumab
All enrolled patients (people living with HIV) who received evolocumab sq once a month for a total of two doses
Overall Study
STARTED
19
Overall Study
COMPLETED
19
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Evolocumab on Coronary Endothelial Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Evolocumab Group
n=19 Participants
Patients (people living with HIV) who received Evolocumab sq once a month for total of 2 doses
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
19 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age, Continuous
52 years
STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male
Female
4 Participants
n=5 Participants
Sex: Female, Male
Male
15 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
14 Participants
n=5 Participants
Race (NIH/OMB)
White
5 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
19 Participants
n=5 Participants
Body Mass Index (BMI)
26 kg/m^2
STANDARD_DEVIATION 5 • n=5 Participants

PRIMARY outcome

Timeframe: 1 week and 6 weeks

Coronary endothelial function will be assessed by the percent change in cross sectional coronary artery area (measured on MRI) from rest to isometric handgrip stress exercise at week 1 and week 6. The percent change from week 1 to week 6 is presented below.

Outcome measures

Outcome measures
Measure
Evolocumab
n=19 Participants
Patients with HIV receiving Evolocumab sq (2 doses total)
Coronary Endothelial Function as Assessed by Percent Coronary Artery Area Change With Isometric Handgrip Exercise
5.6 percent change in coronary artery area
Standard Deviation 5.5

SECONDARY outcome

Timeframe: At 6 weeks

LDL cholesterol level: mg/dL.

Outcome measures

Outcome measures
Measure
Evolocumab
n=19 Participants
Patients with HIV receiving Evolocumab sq (2 doses total)
LDL Cholesterol Level
37 mg/dL
Standard Deviation 19

Adverse Events

Evolocumab

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Allison Hays

Johns Hopkins University

Phone: 443-287-6827

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60