| Trial ID: | L5403 |
| Source ID: | NCT04484259
|
| Associated Drug: |
Ticagrelor Monotherapy
|
| Title: |
Ticagrelor With and Without Aspirin in Patients With Diabetes Mellitus
|
| Acronym: |
OPTIMUS-7
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT04484259/results
|
| Conditions: |
Diabetes Mellitus, Type 2|Coronary Artery Disease
|
| Interventions: |
DRUG: Ticagrelor monotherapy|DRUG: Ticagrelor plus aspirin|DRUG: Clopidogrel with aspirin
|
| Outcome Measures: |
Primary: P2Y12 Reaction Units (PRU), The primary end-point of the study is the comparison of the PRU determined by VerifyNow PRU between between aspirin plus ticagrelor 60 mg and ticagrelor 60 mg monotherapy (trough effect pre-dosing). The VerifyNow System is a turbidimetric based optical detection system which measures platelet induced aggregation as an increase in light transmittance. The assay is based on microbead agglutination induced by adenosine diphosphate (ADP). The instrument measures this change in optical signal and reports results in P2Y12 Reaction Units (PRU)., Day 10, pre-dose | Other: VASP, Comparison of the platelet reactivity index (PRI) determined by VASP between between aspirin plus ticagrelor 60 mg and ticagrelor 60 mg monotherapy. VASP phosphorylation (VASP-P) is a marker of P2Y12 receptor signaling. VASP was assessed the ELISA VASP-P kit. Low PRI indicates appropriate platelet inhibition., Day 10, pre-dose|Comparison of Platelet Aggregation With ADP as Stimuli Determined by Light Transmittance Aggregometry Between Between Aspirin Plus Ticagrelor 60 mg and Ticagrelor 60 mg Monotherapy., Platelet aggregation was stimulated by ADP. Platelet aggregation will be determined as the maximal percent change (MPA%) in light transmittance from baseline. Low MPA% reflects good platelet inhibition., Day 10, pre-dose|Comparison of Thrombus Formation Measured by T-TAS Between Between Aspirin Plus Ticagrelor 60 mg and Ticagrelor 60 mg Monotherapy, T-TAS is an automated microchip flow chamber system for the quantitative analysis of the thrombus formation process under blood flow conditions. In the present study, total platelet-derived thrombus formation is expressed as the area under the flow pressure curve for the first 10 min for the PL-chip tested at a flow rate of 18 μL/min (PL18-AUC10). Results of the assay are reported as PL18-AUC10. Low AUC reflect reduced thrombus growth and rapid breakdown of the thrombus., Day 10, pre-dose
|
| Sponsor/Collaborators: |
Sponsor: University of Florida | Collaborators: AstraZeneca
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
105
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2021-03-31
|
| Completion Date: |
2024-06-15
|
| Results First Posted: |
2025-03-30
|
| Last Update Posted: |
2025-03-30
|
| Locations: |
University of Florida, Jacksonville, Florida, 32209, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04484259
|
