| Trial ID: | L7208 |
| Source ID: | NCT05641753
|
| Associated Drug: |
Evolocumab Cartridge
|
| Title: |
Cholesterol Lowering and Residual Risk in Diabetes, Type 1
|
| Acronym: |
CHORD1
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: Evolocumab Cartridge|DRUG: Atorvastatin Calcium Tablets|DRUG: Ezetimibe Tablets|DRUG: 18F-FDG|DEVICE: Angiocatheter 20IV|DEVICE: J-Wire|DEVICE: GlycoCheck Glycocalyx Measurement Software
|
| Outcome Measures: |
Primary: Change in Monocyte Platelet Aggregation (MPA) from Baseline, Measurement of platelet activity. Assessed via patient blood sample., Baseline, Week 4|Change in Light Transmission Aggregation (LTA) from Baseline, Measurement of platelet activity. Assessed via patient blood sample., Baseline, Week 4 | Secondary: Percent Change in Natural Killer (NK) Cell Population from Baseline, Assessed via patient blood sample., Baseline, Week 4|Percent Change in Dendritic Cell Population from Baseline, Assessed via patient blood sample., Baseline, Week 4|Percent Change in CD8 Cell Population from Baseline, Assessed via patient blood sample., Baseline, Week 4
|
| Sponsor/Collaborators: |
Sponsor: NYU Langone Health | Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
125
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
|
| Start Date: |
2022-12-06
|
| Completion Date: |
2027-07-31
|
| Results First Posted: |
|
| Last Update Posted: |
2025-03-03
|
| Locations: |
New York VA Hospital, New York, New York, 10010, United States|NYC Health + Hospitals/Bellevue, New York, New York, 10016, United States|NYU Langone Health, New York, New York, 10016, United States|Mount Sinai School of Medicine, New York, New York, 10029, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05641753
|
