Trial Outcomes & Findings for Impact of Evolocumab in Cardiac Transplant Patients With CAV (NCT NCT03944577)
NCT ID: NCT03944577
Last Updated: 2024-06-03
Results Overview
The primary outcome measure for this study was percent change in LDL from baseline after 12 weeks of evolocumab therapy. Serum LDL was measured at baseline and after 12 weeks of evolocumab therapy. This primary endpoint was used in prior phase 2 trials investigating evolocumab in other patient populations. Wilcoxon matched-pairs signed rank test was used for statistical assessment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
12 weeks
Results posted on
2024-06-03
Participant Flow
Participant milestones
| Measure |
Evolocumab
Heart transplant participant with Cardiac allograft vasculopathy (CAV) who received the study drug.
Enrolled study participants will be treated with evolocumab (Repatha) 140 mg injected subcutaneously every 2 weeks for 52 weeks.
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Evolocumab
Heart transplant participant with Cardiac allograft vasculopathy (CAV) who received the study drug.
Enrolled study participants will be treated with evolocumab (Repatha) 140 mg injected subcutaneously every 2 weeks for 52 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
Baseline Characteristics
Impact of Evolocumab in Cardiac Transplant Patients With CAV
Baseline characteristics by cohort
| Measure |
Evolocumab
n=26 Participants
Heart transplant participants with CAV who received the study drug. Enrolled study participants will be treated with evolocumab (Repatha) 140 mg injected subcutaneously every 2 weeks for 52 weeks.
|
|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Low density lipoprotein (LDL)
|
100 mg/dL
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: This single arm study investigated the impact of PCSK9 inhibition via evolocumab on serum LDL in heart transplant patients with CAV after 12 weeks compared to baseline. Percent Change in serum LDL will serve as the primary endpoint for comparison.
The primary outcome measure for this study was percent change in LDL from baseline after 12 weeks of evolocumab therapy. Serum LDL was measured at baseline and after 12 weeks of evolocumab therapy. This primary endpoint was used in prior phase 2 trials investigating evolocumab in other patient populations. Wilcoxon matched-pairs signed rank test was used for statistical assessment.
Outcome measures
| Measure |
Evolocumab
n=24 Participants
Heart transplant participant with CAV who received the study drug. Enrolled study participants will be treated with evolocumab (Repatha) 140 mg injected subcutaneously every 2 weeks for 52 weeks.
|
|---|---|
|
Percent Change in Serum LDL (mg/dL) After 12 Weeks of Evolocumab
|
68 percent change
Interval 51.0 to 82.0
|
Adverse Events
Treatment Arm
Serious events: 11 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Arm
n=26 participants at risk
Heart transplant participant with CAV who received the study drug. Enrolled study participants will be treated with evolocumab 140 mg injected subcutaneously every 2 weeks for 52 weeks.
|
|---|---|
|
Infections and infestations
hospitalization
|
11.5%
3/26 • Number of events 3 • 12 months
Adverse events were assessed by research personnel at weeks 2, 4, 12, 26, 38 and study conclusion (week 52).
|
|
Vascular disorders
hospitalization
|
11.5%
3/26 • Number of events 3 • 12 months
Adverse events were assessed by research personnel at weeks 2, 4, 12, 26, 38 and study conclusion (week 52).
|
|
Cardiac disorders
hospitalization
|
11.5%
3/26 • Number of events 3 • 12 months
Adverse events were assessed by research personnel at weeks 2, 4, 12, 26, 38 and study conclusion (week 52).
|
|
Gastrointestinal disorders
hospitalization
|
3.8%
1/26 • Number of events 1 • 12 months
Adverse events were assessed by research personnel at weeks 2, 4, 12, 26, 38 and study conclusion (week 52).
|
|
Musculoskeletal and connective tissue disorders
hospitalization
|
3.8%
1/26 • Number of events 1 • 12 months
Adverse events were assessed by research personnel at weeks 2, 4, 12, 26, 38 and study conclusion (week 52).
|
Other adverse events
| Measure |
Treatment Arm
n=26 participants at risk
Heart transplant participant with CAV who received the study drug. Enrolled study participants will be treated with evolocumab 140 mg injected subcutaneously every 2 weeks for 52 weeks.
|
|---|---|
|
Gastrointestinal disorders
nausea
|
7.7%
2/26 • 12 months
Adverse events were assessed by research personnel at weeks 2, 4, 12, 26, 38 and study conclusion (week 52).
|
|
Infections and infestations
URI/sinus congestion/viral infection
|
23.1%
6/26 • 12 months
Adverse events were assessed by research personnel at weeks 2, 4, 12, 26, 38 and study conclusion (week 52).
|
|
Cardiac disorders
palpitations
|
3.8%
1/26 • 12 months
Adverse events were assessed by research personnel at weeks 2, 4, 12, 26, 38 and study conclusion (week 52).
|
|
Cardiac disorders
rejection
|
3.8%
1/26 • 12 months
Adverse events were assessed by research personnel at weeks 2, 4, 12, 26, 38 and study conclusion (week 52).
|
|
Musculoskeletal and connective tissue disorders
myalgia/back pain
|
19.2%
5/26 • 12 months
Adverse events were assessed by research personnel at weeks 2, 4, 12, 26, 38 and study conclusion (week 52).
|
|
Renal and urinary disorders
overactive bladder
|
3.8%
1/26 • 12 months
Adverse events were assessed by research personnel at weeks 2, 4, 12, 26, 38 and study conclusion (week 52).
|
|
Gastrointestinal disorders
diarrhea
|
3.8%
1/26 • 12 months
Adverse events were assessed by research personnel at weeks 2, 4, 12, 26, 38 and study conclusion (week 52).
|
|
Skin and subcutaneous tissue disorders
phlebitis/urticaria
|
7.7%
2/26 • 12 months
Adverse events were assessed by research personnel at weeks 2, 4, 12, 26, 38 and study conclusion (week 52).
|
|
Skin and subcutaneous tissue disorders
toothache
|
3.8%
1/26 • 12 months
Adverse events were assessed by research personnel at weeks 2, 4, 12, 26, 38 and study conclusion (week 52).
|
|
Musculoskeletal and connective tissue disorders
headache
|
3.8%
1/26 • 12 months
Adverse events were assessed by research personnel at weeks 2, 4, 12, 26, 38 and study conclusion (week 52).
|
|
Nervous system disorders
confusion
|
3.8%
1/26 • 12 months
Adverse events were assessed by research personnel at weeks 2, 4, 12, 26, 38 and study conclusion (week 52).
|
|
Musculoskeletal and connective tissue disorders
fall
|
3.8%
1/26 • 12 months
Adverse events were assessed by research personnel at weeks 2, 4, 12, 26, 38 and study conclusion (week 52).
|
|
Musculoskeletal and connective tissue disorders
toe fracture
|
3.8%
1/26 • 12 months
Adverse events were assessed by research personnel at weeks 2, 4, 12, 26, 38 and study conclusion (week 52).
|
|
Cardiac disorders
Hypertension
|
3.8%
1/26 • 12 months
Adverse events were assessed by research personnel at weeks 2, 4, 12, 26, 38 and study conclusion (week 52).
|
|
Endocrine disorders
hypoglycemia
|
3.8%
1/26 • 12 months
Adverse events were assessed by research personnel at weeks 2, 4, 12, 26, 38 and study conclusion (week 52).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place