| Trial ID: | L3842 |
| Source ID: | NCT03258281
|
| Associated Drug: |
Evolocumab
|
| Title: |
Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus
|
| Acronym: |
ISS-DMII
|
| Status: |
TERMINATED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03258281/results
|
| Conditions: |
Diabetes Mellitus, Type 2|Dyslipidemia Associated With Type II Diabetes Mellitus|Percutaneous Coronary Intervention
|
| Interventions: |
DRUG: Evolocumab|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change From Baseline in Adenosine Diphosphate (ADP) Stimulated P-selectin Expression, 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)., Baseline and after 30 days of treatment | Secondary: Change in ADP-unstimulated P-selectin Expression, Change in ADP-unstimulated P-selectin expression (% Positive Cells) between treatment groups (420 mg evolocumab treatment and placebo), Baseline and after 30 days of treatment|Change in ADP-stimulated Lectin-like oxLDL [Oxidized Low-density Lipoprotein] Receptor-1 Mean Fluorescence Intensity (MFI), Change in ADP-stimulated LOX-1 (MFI) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo), Baseline and after 30 days of treatment|Change in ADP-stimulated Cluster of Differentiation (CD)-147 MFI, Change in ADP-stimulated CD-147 mean fluorescence intensity (MFI) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo), Baseline and after 30 days of treatment
|
| Sponsor/Collaborators: |
Sponsor: Inova Health Care Services
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
4
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2018-05-01
|
| Completion Date: |
2019-10-01
|
| Results First Posted: |
2023-01-19
|
| Last Update Posted: |
2023-01-19
|
| Locations: |
Inova Fairfax Hospital, Falls Church, Virginia, 22042, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03258281
|
