| Trial ID: | L3815 |
| Source ID: | NCT03437044
|
| Associated Drug: |
Ticagrelor
|
| Title: |
Low Maintenance Dose Ticagrelor Versus Clopidogrel in Diabetes Patients Undergoing PCI
|
| Acronym: |
OPTIMUS-6
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03437044/results
|
| Conditions: |
Diabetes Mellitus, Type 2|Coronary Artery Disease
|
| Interventions: |
DRUG: Ticagrelor|DRUG: Clopidogrel
|
| Outcome Measures: |
Primary: P2Y12 Reaction Units (PRU), The primary endpoint of our study will be platelet reactivity, measured as PRU level using VerifyNow PRU, of ticagrelor versus clopidogrel MD at 30 days after PCI, immediately pre-dosing dosing (trough levels). PRU is a marker of platelet reactivity. Higher PRU values correspond to higher aggregation and lower response to antiplatelet therapy., 30 days | Secondary: Platelet Reactivity Index (PRI), Platelet reactivity measured as PRI% using whole blood vasodilator-stimulated phosphoprotein (VASP), of ticagrelor versus clopidogrel MD at 30 days after PCI, immediately pre-dosing dosing (trough levels). PRI% is a marker of platelet reactivity. Higher PRI values correspond to higher aggregation and lower response to antiplatelet therapy., 30 days
|
| Sponsor/Collaborators: |
Sponsor: University of Florida | Collaborators: AstraZeneca
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
40
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2018-03-14
|
| Completion Date: |
2020-06-27
|
| Results First Posted: |
2021-02-05
|
| Last Update Posted: |
2021-11-30
|
| Locations: |
University of Florida, Jacksonville, Florida, 32209, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03437044
|
