| Trial ID: | L5083 |
| Source ID: | NCT04369664
|
| Associated Drug: |
Statin
|
| Title: |
CHOlesterol Lowering and Residual Risk in Type 2 Diabetes
|
| Acronym: |
CHORD
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT04369664/results
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Statin|DRUG: PCSK9 inhibitor|DRUG: Ezetimibe 10mg
|
| Outcome Measures: |
Primary: Percent Change in Platelet Activity (MPA) Before and After Cholesterol Reduction, The difference in platelet activity will be assessed by measuring changes in monocyte-platelet aggregates. Monocyte platelet aggregates (MPA) are a robust marker of platelet activity and inflammatory monocytes. The difference in platelet activity before and after cholesterol reduction will be compared using paired t-test or Wilcoxon signed-rank test. The study will also perform a linear mixed model for the multivariate analysis; the primary outcome will be the change in platelet activity (MPA) before and after cholesterol reduction. All tests will be 2-tailed, and a P \<0.05 will be considered as statistically significant. A positive MPA value indicates increased platelet activity, while a negative MPA value indicates decreased platelet activity., Baseline visit, Follow up visit (4 weeks)|Percent Change in Platelet Activity (LTA) Before and After Cholesterol Reduction, The difference in platelet activity will be assessed by using the light transmission aggregometry test (LTA). Light Transmission Aggregometry \[LTA\] is frequently undertaken as the first test of platelet function, as a screening test for a bleeding disorder and in addition for monitoring of anti-platelet drugs using platelet rich plasma (PRP). The difference in platelet activity before and after cholesterol reduction will be compared using paired t-test or Wilcoxon signed-rank test. We will also perform a linear mixed model for the multivariate analysis; the primary outcome will be the change in platelet activity (LTA) before and after cholesterol reduction. All tests will be 2-tailed, and a P \<0.05 will be considered as statistically significant. A positive value indicates increased platelet activity, while a negative value indicates decreased platelet activity., Baseline visit, Follow up visit (4 weeks) |
|
| Sponsor/Collaborators: |
Sponsor: NYU Langone Health
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
151
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2020-08-12
|
| Completion Date: |
2023-10-19
|
| Results First Posted: |
2024-10-17
|
| Last Update Posted: |
2024-10-17
|
| Locations: |
NYU Langone Health, New York, New York, 10016, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04369664
|
