Trial Outcomes & Findings for Ticagrelor With and Without Aspirin in Patients With Diabetes Mellitus (NCT NCT04484259)
NCT ID: NCT04484259
Last Updated: 2025-03-30
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
105 participants
Primary outcome timeframe
Day 10, pre-dose
Results posted on
2025-03-30
Participant Flow
105 patients consented. * 4 screen failures * 16 withdrawn during run in * 4 lost to follow-up before randomization visit
Participant milestones
| Measure |
Ticagrelor
ticagrelor 60 mg bid monotherapy
Ticagrelor monotherapy: Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
|
Aspirin Plus Clopidogrel
aspirin 81 mg qd plus clopidogrel 75 mg qd
Clopidogrel with aspirin: Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
|
Aspirin Plus Ticagrelor
aspirin 81 mg qd plus ticagrelor 60 mg bid
Ticagrelor plus aspirin: Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
|
Aspirin Plus Ticagrelor 90 mg
Eligible patients entered a 7-10 day run-in phase with aspirin 81 mg qd plus ticagrelor 90 mg bid
|
Ticagrelor 90 mg Monotherapy
Patients discontinued aspirin and maintained ticagrelor 90 mg bid monotherapy for 10±3 days.
|
|---|---|---|---|---|---|
|
Run-in Phase With Aspirin and Ticagrelor
STARTED
|
0
|
0
|
0
|
101
|
0
|
|
Run-in Phase With Aspirin and Ticagrelor
COMPLETED
|
0
|
0
|
0
|
82
|
0
|
|
Run-in Phase With Aspirin and Ticagrelor
NOT COMPLETED
|
0
|
0
|
0
|
19
|
0
|
|
Run-in Phase With Ticagrelor Monotherapy
STARTED
|
0
|
0
|
0
|
0
|
82
|
|
Run-in Phase With Ticagrelor Monotherapy
COMPLETED
|
0
|
0
|
0
|
0
|
81
|
|
Run-in Phase With Ticagrelor Monotherapy
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
|
Randomized Treatment
STARTED
|
26
|
27
|
28
|
0
|
0
|
|
Randomized Treatment
COMPLETED
|
25
|
27
|
28
|
0
|
0
|
|
Randomized Treatment
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Ticagrelor
ticagrelor 60 mg bid monotherapy
Ticagrelor monotherapy: Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
|
Aspirin Plus Clopidogrel
aspirin 81 mg qd plus clopidogrel 75 mg qd
Clopidogrel with aspirin: Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
|
Aspirin Plus Ticagrelor
aspirin 81 mg qd plus ticagrelor 60 mg bid
Ticagrelor plus aspirin: Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
|
Aspirin Plus Ticagrelor 90 mg
Eligible patients entered a 7-10 day run-in phase with aspirin 81 mg qd plus ticagrelor 90 mg bid
|
Ticagrelor 90 mg Monotherapy
Patients discontinued aspirin and maintained ticagrelor 90 mg bid monotherapy for 10±3 days.
|
|---|---|---|---|---|---|
|
Run-in Phase With Aspirin and Ticagrelor
Adverse Event
|
0
|
0
|
0
|
9
|
0
|
|
Run-in Phase With Aspirin and Ticagrelor
Withdrawal by Subject
|
0
|
0
|
0
|
4
|
0
|
|
Run-in Phase With Aspirin and Ticagrelor
Physician Decision
|
0
|
0
|
0
|
2
|
0
|
|
Run-in Phase With Aspirin and Ticagrelor
Lost to Follow-up
|
0
|
0
|
0
|
4
|
0
|
|
Run-in Phase With Ticagrelor Monotherapy
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
|
Randomized Treatment
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Ticagrelor With and Without Aspirin in Patients With Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Ticagrelor
n=26 Participants
ticagrelor 60 mg bid monotherapy
Ticagrelor monotherapy: Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
|
Aspirin Plus Clopidogrel
n=27 Participants
aspirin 81 mg qd plus clopidogrel 75 mg qd
Clopidogrel with aspirin: Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
|
Aspirin Plus Ticagrelor
n=28 Participants
aspirin 81 mg qd plus ticagrelor 60 mg bid
Ticagrelor plus aspirin: Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 8 • n=93 Participants
|
65 years
STANDARD_DEVIATION 8 • n=4 Participants
|
65 years
STANDARD_DEVIATION 10 • n=27 Participants
|
64 years
STANDARD_DEVIATION 8 • n=483 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
36 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
45 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
22 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
57 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Hemoglobin A1c
|
8.0 % of glycated hemoglobin
STANDARD_DEVIATION 2.0 • n=93 Participants
|
7.5 % of glycated hemoglobin
STANDARD_DEVIATION 2.7 • n=4 Participants
|
7.6 % of glycated hemoglobin
STANDARD_DEVIATION 2.4 • n=27 Participants
|
7.7 % of glycated hemoglobin
STANDARD_DEVIATION 2.0 • n=483 Participants
|
PRIMARY outcome
Timeframe: Day 10, pre-doseThe 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).
Outcome measures
| Measure |
Ticagrelor
n=26 Participants
ticagrelor 60 mg bid monotherapy
Ticagrelor monotherapy: Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
|
Aspirin Plus Clopidogrel
n=27 Participants
aspirin 81 mg qd plus clopidogrel 75 mg qd
Clopidogrel with aspirin: Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
|
Aspirin Plus Ticagrelor
n=28 Participants
aspirin 81 mg qd plus ticagrelor 60 mg bid
Ticagrelor plus aspirin: Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
|
|---|---|---|---|
|
P2Y12 Reaction Units (PRU)
|
47 PRU
Interval 26.0 to 68.0
|
136 PRU
Interval 110.0 to 162.0
|
39 PRU
Interval 20.0 to 57.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 10, pre-doseComparison 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.
Outcome measures
| Measure |
Ticagrelor
n=26 Participants
ticagrelor 60 mg bid monotherapy
Ticagrelor monotherapy: Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
|
Aspirin Plus Clopidogrel
n=27 Participants
aspirin 81 mg qd plus clopidogrel 75 mg qd
Clopidogrel with aspirin: Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
|
Aspirin Plus Ticagrelor
n=28 Participants
aspirin 81 mg qd plus ticagrelor 60 mg bid
Ticagrelor plus aspirin: Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
|
|---|---|---|---|
|
VASP
|
77 PRI
Interval 72.0 to 82.0
|
73 PRI
Interval 68.0 to 78.0
|
70 PRI
Interval 66.0 to 76.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 10, pre-dosePlatelet 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.
Outcome measures
| Measure |
Ticagrelor
n=26 Participants
ticagrelor 60 mg bid monotherapy
Ticagrelor monotherapy: Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
|
Aspirin Plus Clopidogrel
n=27 Participants
aspirin 81 mg qd plus clopidogrel 75 mg qd
Clopidogrel with aspirin: Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
|
Aspirin Plus Ticagrelor
n=28 Participants
aspirin 81 mg qd plus ticagrelor 60 mg bid
Ticagrelor plus aspirin: Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
|
|---|---|---|---|
|
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.
|
29 MPA%
Interval 23.0 to 36.0
|
39 MPA%
Interval 33.0 to 45.0
|
26 MPA%
Interval 20.0 to 32.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 10, pre-doseT-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.
Outcome measures
| Measure |
Ticagrelor
n=26 Participants
ticagrelor 60 mg bid monotherapy
Ticagrelor monotherapy: Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
|
Aspirin Plus Clopidogrel
n=27 Participants
aspirin 81 mg qd plus clopidogrel 75 mg qd
Clopidogrel with aspirin: Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
|
Aspirin Plus Ticagrelor
n=28 Participants
aspirin 81 mg qd plus ticagrelor 60 mg bid
Ticagrelor plus aspirin: Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
|
|---|---|---|---|
|
Comparison of Thrombus Formation Measured by T-TAS Between Between Aspirin Plus Ticagrelor 60 mg and Ticagrelor 60 mg Monotherapy
|
258 kPa x minutes
Interval 207.0 to 308.0
|
147 kPa x minutes
Interval 98.0 to 196.0
|
67 kPa x minutes
Interval 19.0 to 115.0
|
Adverse Events
Ticagrelor
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Aspirin Plus Clopidogrel
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Aspirin Plus Ticagrelor
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Aspirin Plus Ticagrelor 90 mg
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Ticagrelor 90 mg Monotherapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ticagrelor
n=26 participants at risk
ticagrelor 60 mg bid monotherapy
Ticagrelor monotherapy: Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
|
Aspirin Plus Clopidogrel
n=27 participants at risk
aspirin 81 mg qd plus clopidogrel 75 mg qd
Clopidogrel with aspirin: Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
|
Aspirin Plus Ticagrelor
n=28 participants at risk
aspirin 81 mg qd plus ticagrelor 60 mg bid
Ticagrelor plus aspirin: Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
|
Aspirin Plus Ticagrelor 90 mg
n=101 participants at risk
7-10 day run-in phase with aspirin 81 mg qd plus ticagrelor 90 mg bid
|
Ticagrelor 90 mg Monotherapy
n=82 participants at risk
discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days
|
|---|---|---|---|---|---|
|
Surgical and medical procedures
iliac artery perforation
|
0.00%
0/26 • 10 days
These adverse event reporting reflects adverse events occurred during the randomized phase of the study.
|
0.00%
0/27 • 10 days
These adverse event reporting reflects adverse events occurred during the randomized phase of the study.
|
0.00%
0/28 • 10 days
These adverse event reporting reflects adverse events occurred during the randomized phase of the study.
|
0.99%
1/101 • Number of events 1 • 10 days
These adverse event reporting reflects adverse events occurred during the randomized phase of the study.
|
0.00%
0/82 • 10 days
These adverse event reporting reflects adverse events occurred during the randomized phase of the study.
|
|
Cardiac disorders
chest pain
|
0.00%
0/26 • 10 days
These adverse event reporting reflects adverse events occurred during the randomized phase of the study.
|
0.00%
0/27 • 10 days
These adverse event reporting reflects adverse events occurred during the randomized phase of the study.
|
0.00%
0/28 • 10 days
These adverse event reporting reflects adverse events occurred during the randomized phase of the study.
|
0.99%
1/101 • Number of events 1 • 10 days
These adverse event reporting reflects adverse events occurred during the randomized phase of the study.
|
0.00%
0/82 • 10 days
These adverse event reporting reflects adverse events occurred during the randomized phase of the study.
|
Other adverse events
| Measure |
Ticagrelor
n=26 participants at risk
ticagrelor 60 mg bid monotherapy
Ticagrelor monotherapy: Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
|
Aspirin Plus Clopidogrel
n=27 participants at risk
aspirin 81 mg qd plus clopidogrel 75 mg qd
Clopidogrel with aspirin: Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
|
Aspirin Plus Ticagrelor
n=28 participants at risk
aspirin 81 mg qd plus ticagrelor 60 mg bid
Ticagrelor plus aspirin: Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
|
Aspirin Plus Ticagrelor 90 mg
n=101 participants at risk
7-10 day run-in phase with aspirin 81 mg qd plus ticagrelor 90 mg bid
|
Ticagrelor 90 mg Monotherapy
n=82 participants at risk
discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
26.9%
7/26 • Number of events 7 • 10 days
These adverse event reporting reflects adverse events occurred during the randomized phase of the study.
|
44.4%
12/27 • Number of events 12 • 10 days
These adverse event reporting reflects adverse events occurred during the randomized phase of the study.
|
25.0%
7/28 • Number of events 7 • 10 days
These adverse event reporting reflects adverse events occurred during the randomized phase of the study.
|
6.9%
7/101 • Number of events 7 • 10 days
These adverse event reporting reflects adverse events occurred during the randomized phase of the study.
|
0.00%
0/82 • 10 days
These adverse event reporting reflects adverse events occurred during the randomized phase of the study.
|
Additional Information
Francesco Franchi, MD
University of Florida College of Medicine Jacksonville
Phone: 904-244-5515
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place