| Trial ID: | L3611 |
| Source ID: | NCT01852214
|
| Associated Drug: |
Prasugrel
|
| Title: |
Pharmacodynamic Effect of Prasugrel vs. Ticagrelor in Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01852214/results
|
| Conditions: |
Diabetes Mellitus|Coronary Artery Disease
|
| Interventions: |
DRUG: Prasugrel|DRUG: Ticagrelor
|
| Outcome Measures: |
Primary: P2Y12 Reaction Units, The primary endpoint is the comparison of the P2Y12 reaction units (PRU) values determined by VerifyNow between both treatments (ticagrelor or prasugrel). Treatment effects were evaluated comparing PRU observed in the overall patient population after prasugrel treatment with those achieved after ticagrelor regardless of the sequence., 1 week | Secondary: P2Y12 Reaction Units, Comparison of the P2Y12 reaction units (PRU) values determined by VerifyNow between both treatments (ticagrelor or prasugrel), 2 hours|Platelet Reactivity Index, The comparison of the platelet reactivity index (PRI) values determined by vasodilator-stimulated phosphoprotein (VASP) between both treatments (ticagrelor or prasugrel). VASP was measured by quantitative flow cytometry using commercially available labelled monoclonal antibodies. A low PRI is indicative of high platelet inhibition., 1 week|Platelet Reactivity Index, The comparison of the platelet reactivity index (PRI) values determined by vasodilator-stimulated phosphoprotein (VASP) between both treatments (ticagrelor or prasugrel). VASP was measured by quantitative flow cytometry using commercially available labelled monoclonal antibodies. A low PRI is indicative of high platelet inhibition., 2 hours
|
| Sponsor/Collaborators: |
Sponsor: University of Florida
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
50
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-02
|
| Completion Date: |
2015-08
|
| Results First Posted: |
2016-10-17
|
| Last Update Posted: |
2016-10-17
|
| Locations: |
University of Florida, Jacksonville, Florida, 32209, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01852214
|