Trial Outcomes & Findings for Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus (NCT NCT03258281)
NCT ID: NCT03258281
Last Updated: 2023-01-19
Results Overview
Change from baseline in ADP-stimulated P-selectin expression (% Positive Cells) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo).
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
4 participants
Primary outcome timeframe
Baseline and after 30 days of treatment
Results posted on
2023-01-19
Participant Flow
A total of 31 participants were screened, 4 met eligibility and were randomized to the study treatment.
Participant milestones
| Measure |
Evolocumab 420mg
Participants on optimal statin therapy undergoing elective percutaneous coronary intervention (PCI) will receive evolocumab 420mg.
Evolocumab: Participants will receive evolocumab 420 mg administered subcutaneously
|
Placebo
Participants on optimal statin therapy undergoing elective percutaneous coronary intervention (PCI) will receive placebo
Placebo: Participants will receive placebo administered subcutaneously
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
1
|
|
Overall Study
COMPLETED
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Evolocumab 420mg
n=3 Participants
Participants on optimal statin therapy undergoing elective PCI will receive evolocumab 420mg.
Evolocumab: Participants will receive evolocumab 420 mg administered subcutaneously
|
Placebo
n=1 Participants
Participants on optimal statin therapy undergoing elective PCI will receive placebo
Placebo: Participants will receive placebo administered subcutaneously
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION 8 • n=5 Participants
|
67 years
STANDARD_DEVIATION 0 • n=7 Participants
|
69 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 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
|
PRIMARY outcome
Timeframe: Baseline and after 30 days of treatmentPopulation: Instrument malfunction with flow cytometer. Unable to collect data from subject (n=1) in placebo group.
Change from baseline in ADP-stimulated P-selectin expression (% Positive Cells) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo).
Outcome measures
| Measure |
Evolocumab 420mg
n=3 Participants
Participants on optimal statin therapy undergoing elective PCI will receive evolocumab 420mg.
Evolocumab: Participants will receive evolocumab 420 mg administered subcutaneously
|
Placebo
Participants on optimal statin therapy undergoing elective PCI will receive placebo
Placebo: Participants will receive placebo administered subcutaneously
|
|---|---|---|
|
Change From Baseline in Adenosine Diphosphate (ADP) Stimulated P-selectin Expression
Baseline
|
45.2 % Positive Cells
Standard Deviation 17.1
|
—
|
|
Change From Baseline in Adenosine Diphosphate (ADP) Stimulated P-selectin Expression
30 Days
|
47.8 % Positive Cells
Standard Deviation 18.8
|
—
|
SECONDARY outcome
Timeframe: Baseline and after 30 days of treatmentPopulation: Instrument malfunction with flow cytometer. Unable to collect data from subject (n=1) in placebo group.
Change in ADP-unstimulated P-selectin expression (% Positive Cells) between treatment groups (420 mg evolocumab treatment and placebo)
Outcome measures
| Measure |
Evolocumab 420mg
n=3 Participants
Participants on optimal statin therapy undergoing elective PCI will receive evolocumab 420mg.
Evolocumab: Participants will receive evolocumab 420 mg administered subcutaneously
|
Placebo
Participants on optimal statin therapy undergoing elective PCI will receive placebo
Placebo: Participants will receive placebo administered subcutaneously
|
|---|---|---|
|
Change in ADP-unstimulated P-selectin Expression
Baseline
|
5.4 % Positive Cells
Standard Deviation 2.7
|
—
|
|
Change in ADP-unstimulated P-selectin Expression
30 Days
|
8.8 % Positive Cells
Standard Deviation 2.9
|
—
|
SECONDARY outcome
Timeframe: Baseline and after 30 days of treatmentPopulation: Instrument malfunction with flow cytometer. Unable to collect data from subject (n=1) in placebo group.
Change in ADP-stimulated LOX-1 (MFI) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo)
Outcome measures
| Measure |
Evolocumab 420mg
n=3 Participants
Participants on optimal statin therapy undergoing elective PCI will receive evolocumab 420mg.
Evolocumab: Participants will receive evolocumab 420 mg administered subcutaneously
|
Placebo
Participants on optimal statin therapy undergoing elective PCI will receive placebo
Placebo: Participants will receive placebo administered subcutaneously
|
|---|---|---|
|
Change in ADP-stimulated Lectin-like oxLDL [Oxidized Low-density Lipoprotein] Receptor-1 Mean Fluorescence Intensity (MFI)
Baseline
|
1186 MFI
Standard Deviation 1017
|
—
|
|
Change in ADP-stimulated Lectin-like oxLDL [Oxidized Low-density Lipoprotein] Receptor-1 Mean Fluorescence Intensity (MFI)
30 Days
|
721 MFI
Standard Deviation 82
|
—
|
SECONDARY outcome
Timeframe: Baseline and after 30 days of treatmentPopulation: Instrument malfunction with flow cytometer. Unable to collect data from subject (n=1) in placebo group.
Change in ADP-stimulated CD-147 mean fluorescence intensity (MFI) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo)
Outcome measures
| Measure |
Evolocumab 420mg
n=3 Participants
Participants on optimal statin therapy undergoing elective PCI will receive evolocumab 420mg.
Evolocumab: Participants will receive evolocumab 420 mg administered subcutaneously
|
Placebo
Participants on optimal statin therapy undergoing elective PCI will receive placebo
Placebo: Participants will receive placebo administered subcutaneously
|
|---|---|---|
|
Change in ADP-stimulated Cluster of Differentiation (CD)-147 MFI
30 Days
|
678 MFI
Standard Deviation 148
|
—
|
|
Change in ADP-stimulated Cluster of Differentiation (CD)-147 MFI
Baseline
|
1459 MFI
Standard Deviation 1220
|
—
|
Adverse Events
Evolocumab 420mg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Evolocumab 420mg
n=3 participants at risk
75 subjects on optimal statin therapy undergoing elective PCI will receive evolocumab 420mg.
Evolocumab: Patients will receive evolocumab 420 mg administered subcutaneously
|
Placebo
n=1 participants at risk
75 subjects on optimal statin therapy undergoing elective PCI will receive placebo
Placebo: Patients will receive placebo administered subcutaneously
|
|---|---|---|
|
Cardiac disorders
Chest pain
|
33.3%
1/3 • Number of events 1 • 30 Days
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have to have a causal relationship with this treatment. An adverse event can be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a drug. This includes any newly occurring event that has increased in severity or frequency since the administration of the study treatment.
|
0.00%
0/1 • 30 Days
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have to have a causal relationship with this treatment. An adverse event can be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a drug. This includes any newly occurring event that has increased in severity or frequency since the administration of the study treatment.
|
Other adverse events
| Measure |
Evolocumab 420mg
n=3 participants at risk
75 subjects on optimal statin therapy undergoing elective PCI will receive evolocumab 420mg.
Evolocumab: Patients will receive evolocumab 420 mg administered subcutaneously
|
Placebo
n=1 participants at risk
75 subjects on optimal statin therapy undergoing elective PCI will receive placebo
Placebo: Patients will receive placebo administered subcutaneously
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
rash
|
33.3%
1/3 • Number of events 1 • 30 Days
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have to have a causal relationship with this treatment. An adverse event can be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a drug. This includes any newly occurring event that has increased in severity or frequency since the administration of the study treatment.
|
0.00%
0/1 • 30 Days
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have to have a causal relationship with this treatment. An adverse event can be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a drug. This includes any newly occurring event that has increased in severity or frequency since the administration of the study treatment.
|
Additional Information
Director of Clinical Trials
Sinai Center for Thrombosis Research
Phone: 443-244-1497
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60