Trial Outcomes & Findings for Pharmacodynamic Evaluation of Switching From Prasugrel to Ticagrelor (NCT NCT02016170)
NCT ID: NCT02016170
Last Updated: 2024-07-03
Results Overview
The primary hypothesis of our study was that after 1 week of randomized treatment PRU levels would be non-inferior in patients switched from prasugrel to ticagrelor (two arms combined) compared with patients remaining on prasugrel.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
82 participants
Primary outcome timeframe
7 days
Results posted on
2024-07-03
Participant Flow
Between March 2014 and October 2015, a total of 150 patients on maintenance DAPT with aspirin and prasugrel were identified. Of these, 83 patients meeting study entry criteria agreed to participate and provided their written informed consent.
One patient was excluded after providing informed consent because of inadequate venous access. Thus a total of 82 patients were randomized.
Participant milestones
| Measure |
Ticagrelor 180mg
Patients on prasugrel will switch to ticagrelor with a 180mg loading dose followed by 90 mg BID maintenance dose for 7±2 days.
|
Ticagrelor 90mg
Patients on prasugrel will switch to ticagrelor with a 90mg maintenance dose followed by 90 mg BID maintenance dose for 7±2 days
|
Prasugrel 10mg
Patients already on prasugrel, will maintain prasugrel 10 mg once daily MD for 7±2 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
27
|
28
|
27
|
|
Overall Study
COMPLETED
|
25
|
27
|
27
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
Ticagrelor 180mg
Patients on prasugrel will switch to ticagrelor with a 180mg loading dose followed by 90 mg BID maintenance dose for 7±2 days.
|
Ticagrelor 90mg
Patients on prasugrel will switch to ticagrelor with a 90mg maintenance dose followed by 90 mg BID maintenance dose for 7±2 days
|
Prasugrel 10mg
Patients already on prasugrel, will maintain prasugrel 10 mg once daily MD for 7±2 days
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
Baseline Characteristics
Pharmacodynamic Evaluation of Switching From Prasugrel to Ticagrelor
Baseline characteristics by cohort
| Measure |
Ticagrelor 180mg
n=25 Participants
Patients on prasugrel will switch to ticagrelor with a 180mg loading dose followed by 90 mg BID maintenance dose for 7±2 days.
|
Ticagrelor 90mg
n=27 Participants
Patients on prasugrel will switch to ticagrelor with a 90mg maintenance dose followed by 90 mg BID maintenance dose for 7±2 days
|
Prasugrel 10mg
n=27 Participants
Patients already on prasugrel, will maintain prasugrel 10 mg once daily MD for 7±2 days
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 10 • n=5 Participants
|
57 years
STANDARD_DEVIATION 7 • n=7 Participants
|
57 years
STANDARD_DEVIATION 7 • n=5 Participants
|
57 years
STANDARD_DEVIATION 8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 7 daysPopulation: Analysis was conducted in patients who received the randomized treatment and had a valid primary end point value (PRU at 1 week).
The primary hypothesis of our study was that after 1 week of randomized treatment PRU levels would be non-inferior in patients switched from prasugrel to ticagrelor (two arms combined) compared with patients remaining on prasugrel.
Outcome measures
| Measure |
Ticagrelor
n=52 Participants
Patients switched to ticagrelor (two arms combined) with or without a loading dose and receiving ticagrelor 90 mg bid for 7 days.
|
Prasugrel
n=27 Participants
Patients already on prasugrel, will maintain prasugrel 10 mg once daily MD for 7 days
|
|---|---|---|
|
Platelet Reactivity Measured as P2Y12 Reaction Units (PRU) Determined by Verify Now-P2Y12 Assay
|
45 PRU
Standard Error 6
|
63 PRU
Standard Error 9
|
SECONDARY outcome
Timeframe: 7 daysThe secondary hypothesis of our study was that after 1 week of randomized treatment PRI levels would be non-inferior in patients switched from prasugrel to ticagrelor (two arms combined) compared with patients remaining on prasugrel. VASP was measured by quantitative flow cytometry using commercially available labelled monoclonal antibodies.
Outcome measures
| Measure |
Ticagrelor
n=52 Participants
Patients switched to ticagrelor (two arms combined) with or without a loading dose and receiving ticagrelor 90 mg bid for 7 days.
|
Prasugrel
n=27 Participants
Patients already on prasugrel, will maintain prasugrel 10 mg once daily MD for 7 days
|
|---|---|---|
|
Platelet Reactivity Index (PRI) Measured by Whole Blood Vasodilator-stimulated Phosphoprotein (VASP).
|
25 PRI
Standard Deviation 6
|
36 PRI
Standard Deviation 9
|
Adverse Events
Ticagrelor 180mg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Ticagrelor 90mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Prasugrel 10mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ticagrelor 180mg
n=27 participants at risk
Patients on prasugrel will switch to ticagrelor with a 180mg loading dose followed by 90 mg BID maintenance dose for 7±2 days.
|
Ticagrelor 90mg
n=28 participants at risk
Patients on prasugrel will switch to ticagrelor with a 90mg maintenance dose followed by 90 mg BID maintenance dose for 7±2 days
|
Prasugrel 10mg
n=27 participants at risk
Patients already on prasugrel, will maintain prasugrel 10 mg once daily MD for 7±2 days
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Angioedema
|
3.7%
1/27 • Number of events 1 • 1 week
The treated population comprised all patients who received any dose of study medication and was considered for analysis of safety and adverse events.
|
0.00%
0/28 • 1 week
The treated population comprised all patients who received any dose of study medication and was considered for analysis of safety and adverse events.
|
0.00%
0/27 • 1 week
The treated population comprised all patients who received any dose of study medication and was considered for analysis of safety and adverse events.
|
Other adverse events
| Measure |
Ticagrelor 180mg
n=27 participants at risk
Patients on prasugrel will switch to ticagrelor with a 180mg loading dose followed by 90 mg BID maintenance dose for 7±2 days.
|
Ticagrelor 90mg
n=28 participants at risk
Patients on prasugrel will switch to ticagrelor with a 90mg maintenance dose followed by 90 mg BID maintenance dose for 7±2 days
|
Prasugrel 10mg
n=27 participants at risk
Patients already on prasugrel, will maintain prasugrel 10 mg once daily MD for 7±2 days
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
37.0%
10/27 • Number of events 10 • 1 week
The treated population comprised all patients who received any dose of study medication and was considered for analysis of safety and adverse events.
|
25.0%
7/28 • Number of events 7 • 1 week
The treated population comprised all patients who received any dose of study medication and was considered for analysis of safety and adverse events.
|
0.00%
0/27 • 1 week
The treated population comprised all patients who received any dose of study medication and was considered for analysis of safety and adverse events.
|
Additional Information
Dominick J. Angiolillo, MD, PhD
University of Florida College of Medicine-Jacksonville
Phone: +1-904-244-3933
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place