Trial Outcomes & Findings for Effect of Evolocumab on Coronary Atherosclerosis (NCT NCT03689946)
NCT ID: NCT03689946
Last Updated: 2024-07-17
Results Overview
Compare NCPV in mm\^3 measured on cardiac CT images as analyzed by quantitative software between the two assessments
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
55 participants
Primary outcome timeframe
baseline (pre-treatment) and 18 months after of treatment
Results posted on
2024-07-17
Participant Flow
Participant milestones
| Measure |
Evolocumab, F18-NaF PET, CCTA
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).
Evolocumab: Evolocumab: In patients without homozygous familial hypercholesterolemia (FH), evolocumab will be self-injected as follows: 140mg every 2 weeks or 420mg once a month subcutaneously.
Patients with homozygous FH will be instructed to administer 420mg subcutaneously once a month by giving 3 injections consecutively within 30 minutes using the single-use prefilled autoinjector.
18F-NaF PET: 18F-NaF PET: Baseline (pre-treatment) and follow-up dual cardiac and respiratory-gated PET- imaging of the thoracic aorta. Dose of 250 MBq 18F-NaF intravenously.
CCTA: CCTA: Baseline (pre-treatment) and follow-up CCTA. Bolus injection of 80-100 ml contrast (Omnipaque or Visipaque). Possible beta blocker(metoprolol)administered to achieve a target heart ≤70 beats/min (bpm) and/or 0.4 or 0.8 mg of sublingual nitroglycerin administered, if medical safe.
Omnipaque: contrast agent for CCTA
Metoprolol: beta blocker to optimize heart rate during CCTA
Nitroglycerin: premedication for CCTA
|
|---|---|
|
Overall Study
STARTED
|
55
|
|
Overall Study
COMPLETED
|
47
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Evolocumab, F18-NaF PET, CCTA
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).
Evolocumab: Evolocumab: In patients without homozygous familial hypercholesterolemia (FH), evolocumab will be self-injected as follows: 140mg every 2 weeks or 420mg once a month subcutaneously.
Patients with homozygous FH will be instructed to administer 420mg subcutaneously once a month by giving 3 injections consecutively within 30 minutes using the single-use prefilled autoinjector.
18F-NaF PET: 18F-NaF PET: Baseline (pre-treatment) and follow-up dual cardiac and respiratory-gated PET- imaging of the thoracic aorta. Dose of 250 MBq 18F-NaF intravenously.
CCTA: CCTA: Baseline (pre-treatment) and follow-up CCTA. Bolus injection of 80-100 ml contrast (Omnipaque or Visipaque). Possible beta blocker(metoprolol)administered to achieve a target heart ≤70 beats/min (bpm) and/or 0.4 or 0.8 mg of sublingual nitroglycerin administered, if medical safe.
Omnipaque: contrast agent for CCTA
Metoprolol: beta blocker to optimize heart rate during CCTA
Nitroglycerin: premedication for CCTA
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Data corruption
|
2
|
Baseline Characteristics
Effect of Evolocumab on Coronary Atherosclerosis
Baseline characteristics by cohort
| Measure |
Evolocumab, F18-NaF PET, CCTA
n=47 Participants
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).
Evolocumab: Evolocumab: In patients without homozygous familial hypercholesterolemia (FH), evolocumab will be self-injected as follows: 140mg every 2 weeks or 420mg once a month subcutaneously.
Patients with homozygous FH will be instructed to administer 420mg subcutaneously once a month by giving 3 injections consecutively within 30 minutes using the single-use prefilled autoinjector.
18F-NaF PET: 18F-NaF PET: Baseline (pre-treatment) and follow-up dual cardiac and respiratory-gated PET- imaging of the thoracic aorta. Dose of 250 MBq 18F-NaF intravenously.
CCTA: CCTA: Baseline (pre-treatment) and follow-up CCTA. Bolus injection of 80-100 ml contrast (Omnipaque or Visipaque). Possible beta blocker(metoprolol)administered to achieve a target heart ≤70 beats/min (bpm) and/or 0.4 or 0.8 mg of sublingual nitroglycerin administered, if medical safe.
Omnipaque: contrast agent for CCTA
Metoprolol: beta blocker to optimize heart rate during CCTA
Nitroglycerin: premedication for CCTA
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=5 Participants
|
|
Age, Continuous
|
61.8 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=5 Participants
|
|
BMI
|
26.8 kg/m^2
STANDARD_DEVIATION 4.4 • n=5 Participants
|
|
Risk factors
Hypertension
|
25 Participants
n=5 Participants
|
|
Risk factors
Diabetes
|
10 Participants
n=5 Participants
|
|
Risk factors
Hypercholesterolemia
|
42 Participants
n=5 Participants
|
|
Risk factors
Current smoker
|
1 Participants
n=5 Participants
|
|
Risk factors
Prior CAD history
|
4 Participants
n=5 Participants
|
|
Risk factors
Prior CVA history
|
1 Participants
n=5 Participants
|
|
Medication
Aspirin
|
29 Participants
n=5 Participants
|
|
Medication
Statin
|
38 Participants
n=5 Participants
|
|
Medication
ACEi or ARB
|
15 Participants
n=5 Participants
|
|
Medication
Beta blocker
|
17 Participants
n=5 Participants
|
|
Medication
Calcium channel blocker
|
7 Participants
n=5 Participants
|
|
Plaque volume
Total plaque volume
|
716 mm^3
STANDARD_DEVIATION 431 • n=5 Participants
|
|
Plaque volume
Non calcified plaque volume
|
607 mm^3
STANDARD_DEVIATION 347 • n=5 Participants
|
|
Plaque volume
Low density non calcified plaque volume
|
37 mm^3
STANDARD_DEVIATION 29 • n=5 Participants
|
|
Plaque volume
Calcified plaque volume
|
109 mm^3
STANDARD_DEVIATION 134 • n=5 Participants
|
|
Cholesterol level
Total choleseterol
|
155.8 mg/dL
STANDARD_DEVIATION 46.1 • n=5 Participants
|
|
Cholesterol level
LDL cholesterol
|
82.2 mg/dL
STANDARD_DEVIATION 38.9 • n=5 Participants
|
|
Cholesterol level
HDL cholesterol
|
47.9 mg/dL
STANDARD_DEVIATION 14.4 • n=5 Participants
|
|
Cholesterol level
Triglycerides
|
137.6 mg/dL
STANDARD_DEVIATION 81.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline (pre-treatment) and 18 months after of treatmentCompare NCPV in mm\^3 measured on cardiac CT images as analyzed by quantitative software between the two assessments
Outcome measures
| Measure |
Evolocumab, F18-NaF PET, CCTA
n=47 Participants
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).
Evolocumab: Evolocumab: In patients without homozygous familial hypercholesterolemia (FH), evolocumab will be self-injected as follows: 140mg every 2 weeks or 420mg once a month subcutaneously.
Patients with homozygous FH will be instructed to administer 420mg subcutaneously once a month by giving 3 injections consecutively within 30 minutes using the single-use prefilled autoinjector.
18F-NaF PET: 18F-NaF PET: Baseline (pre-treatment) and follow-up dual cardiac and respiratory-gated PET- imaging of the thoracic aorta. Dose of 250 MBq 18F-NaF intravenously.
CCTA: CCTA: Baseline (pre-treatment) and follow-up CCTA. Bolus injection of 80-100 ml contrast (Omnipaque or Visipaque). Possible beta blocker(metoprolol)administered to achieve a target heart ≤70 beats/min (bpm) and/or 0.4 or 0.8 mg of sublingual nitroglycerin administered, if medical safe.
Omnipaque: contrast agent for CCTA
Metoprolol: beta blocker to optimize heart rate during CCTA
Nitroglycerin: premedication for CCTA
|
|---|---|
|
Change in Noncalcified Coronary Artery Plaque Volume (NCPV)
|
-45 mm^3
Standard Deviation 64
|
SECONDARY outcome
Timeframe: baseline (pre-treatment) and 18 months after of treatmentChances in volume of type of plaque (total, calcified, low density non calcified) on cardiac CT images as detected by quantitative software between the two assessments
Outcome measures
| Measure |
Evolocumab, F18-NaF PET, CCTA
n=47 Participants
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).
Evolocumab: Evolocumab: In patients without homozygous familial hypercholesterolemia (FH), evolocumab will be self-injected as follows: 140mg every 2 weeks or 420mg once a month subcutaneously.
Patients with homozygous FH will be instructed to administer 420mg subcutaneously once a month by giving 3 injections consecutively within 30 minutes using the single-use prefilled autoinjector.
18F-NaF PET: 18F-NaF PET: Baseline (pre-treatment) and follow-up dual cardiac and respiratory-gated PET- imaging of the thoracic aorta. Dose of 250 MBq 18F-NaF intravenously.
CCTA: CCTA: Baseline (pre-treatment) and follow-up CCTA. Bolus injection of 80-100 ml contrast (Omnipaque or Visipaque). Possible beta blocker(metoprolol)administered to achieve a target heart ≤70 beats/min (bpm) and/or 0.4 or 0.8 mg of sublingual nitroglycerin administered, if medical safe.
Omnipaque: contrast agent for CCTA
Metoprolol: beta blocker to optimize heart rate during CCTA
Nitroglycerin: premedication for CCTA
|
|---|---|
|
Change in Plaque Composition (Total, Calcified, Low Density Non Calcified)
Changes in total plaque volume
|
-5 mm^3
Standard Deviation 97
|
|
Change in Plaque Composition (Total, Calcified, Low Density Non Calcified)
Changes in calcified plaque volume
|
40 mm^3
Standard Deviation 56
|
|
Change in Plaque Composition (Total, Calcified, Low Density Non Calcified)
Changes in low density non calcified plaque volume
|
-17 mm^3
Standard Deviation 24
|
Adverse Events
Evolocumab, F18-NaF PET, CCTA
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Evolocumab, F18-NaF PET, CCTA
n=55 participants at risk
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).
Evolocumab: Evolocumab: In patients without homozygous familial hypercholesterolemia (FH), evolocumab will be self-injected as follows: 140mg every 2 weeks or 420mg once a month subcutaneously.
Patients with homozygous FH will be instructed to administer 420mg subcutaneously once a month by giving 3 injections consecutively within 30 minutes using the single-use prefilled autoinjector.
18F-NaF PET: 18F-NaF PET: Baseline (pre-treatment) and follow-up dual cardiac and respiratory-gated PET- imaging of the thoracic aorta. Dose of 250 MBq 18F-NaF intravenously.
CCTA: CCTA: Baseline (pre-treatment) and follow-up CCTA. Bolus injection of 80-100 ml contrast (Omnipaque or Visipaque). Possible beta blocker(metoprolol)administered to achieve a target heart ≤70 beats/min (bpm) and/or 0.4 or 0.8 mg of sublingual nitroglycerin administered, if medical safe.
Omnipaque: contrast agent for CCTA
Metoprolol: beta blocker to optimize heart rate during CCTA
Nitroglycerin: premedication for CCTA
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
runny nose
|
5.5%
3/55 • Number of events 3 • Duration of the study (18 months)
Only adverse events that occurred in at least 5% of the cohort were reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place