| Trial ID: | L1316 |
| Source ID: | NCT03774394
|
| Associated Drug: |
Clopidogrel
|
| Title: |
Impact of Chronic Kidney Disease on Clopidogrel Effects in Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03774394/results
|
| Conditions: |
Chronic Kidney Disease (CKD)|Type 2 Diabetes Mellitus (T2DM)|Coronary Artery Disease (CAD)
|
| Interventions: |
DRUG: Clopidogrel|DRUG: Clopidogrel active metabolite
|
| Outcome Measures: |
Primary: Platelet Reactivity Index (PRI) Assessed by VASP. The Cutoff for High Platelet Reactivity is >50%, Comparison of platelet reactivity measured as PRI assessed by VASP after a 600 mg clopidogrel LD between DM patients with and without CKD, 6 hours | Secondary: Clopidogrel Active Metabolite Concentration, Comparison of clopidogrel active metabolite plasma concentrations by means of AUC, 6 hours | Other: P2Y12 Reaction Units (PRU) Assessed by VerifyNow. The Cutoff for High Platelet Reactivity is >208., Comparison of platelet reactivity measured as PRU assessed by VerifyNow after a 600 mg clopidogrel LD between DM patients with and without CKD, 6 hours|Platelet Reactivity Index (PRI) Assessed by VASP. The Cutoff for High Platelet Reactivity is >50%, Comparison of of platelet reactivity measured as PRI assessed by VASP after incubation with clopidogrel active metabolite between DM patients with and without CKD, Baseline
|
| Sponsor/Collaborators: |
Sponsor: University of Florida | Collaborators: Scott R. MacKenzie Foundation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
61
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2019-08-22
|
| Completion Date: |
2022-05-31
|
| Results First Posted: |
2023-08-21
|
| Last Update Posted: |
2023-08-21
|
| Locations: |
University of Florida Jacksonville, Jacksonville, Florida, 32209, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03774394
|
