Trial Outcomes & Findings for Effect of Vascepa on Improving Coronary Atherosclerosis in People With High Triglycerides Taking Statin Therapy (NCT NCT02926027)
NCT ID: NCT02926027
Last Updated: 2023-02-21
Results Overview
low attenuation plaque volume change from baseline to 18 months
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
80 participants
Primary outcome timeframe
18 months
Results posted on
2023-02-21
Participant Flow
Participant milestones
| Measure |
Active Subjects
Vascepa (4 gm/day), oral dose
Vascepa: Vascepa is a an Eicosapentaenoic acid (EPA), an omega-3 polyunsaturated fatty acid.
|
Placebo Subject
oral dose of placebo
placebo: placebo
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
31
|
37
|
|
Overall Study
NOT COMPLETED
|
9
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Vascepa on Improving Coronary Atherosclerosis in People With High Triglycerides Taking Statin Therapy
Baseline characteristics by cohort
| Measure |
Active Subjects
n=40 Participants
Vascepa (4 gm/day), oral dose
Vascepa: Vascepa is a an Eicosapentaenoic acid (EPA), an omega-3 polyunsaturated fatty acid.
|
Placebo Subject
n=40 Participants
oral dose of placebo
placebo: placebo
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
58.3 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
57.4 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
80 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: completed study
low attenuation plaque volume change from baseline to 18 months
Outcome measures
| Measure |
Active Subjects
n=31 Participants
Vascepa (4 gm/day), oral dose
Vascepa: Vascepa is a an Eicosapentaenoic acid (EPA), an omega-3 polyunsaturated fatty acid.
|
Placebo Subject
n=37 Participants
oral dose of placebo
placebo: placebo
|
|---|---|---|
|
Progression Rates of Low Attenuation Plaque Under Influence of Vascepa as Compared to Placebo as a Change Between Two or More Time Points
|
-0.3 volume in mm cubed
Standard Deviation 1.5
|
0.9 volume in mm cubed
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: all participants finishing final CT angiogram
the measure is reported as volume of non-calcified plaque, as the secondary measure has been reported.
Outcome measures
| Measure |
Active Subjects
n=31 Participants
Vascepa (4 gm/day), oral dose
Vascepa: Vascepa is a an Eicosapentaenoic acid (EPA), an omega-3 polyunsaturated fatty acid.
|
Placebo Subject
n=37 Participants
oral dose of placebo
placebo: placebo
|
|---|---|---|
|
The Composition of Non-calcified Coronary Atherosclerotic Plaque (NCP)
|
-0.8 MM CUBED
Standard Deviation 1.2
|
0.3 MM CUBED
Standard Deviation 1.3
|
Adverse Events
Active Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Subject
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place