Trial Outcomes & Findings for Vorapaxar in Patients With Prior Myocardial Infarction Treated With Prasugrel and Ticagrelor (NCT NCT02545933)
NCT ID: NCT02545933
Last Updated: 2020-09-16
Results Overview
The primary end point of our study is the comparison of maximal platelet aggregation measured by light transmittance aggregometry using CAT (collagen-ADP-TRAP) between DAPT and DAPT plus vorapaxar after 30 days of treatment.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
130 participants
Primary outcome timeframe
30 days
Results posted on
2020-09-16
Participant Flow
Participant milestones
| Measure |
Prasugrel/Ticagrelor Plus Vorapaxar
Prasugrel or ticagrelor plus vorapaxar 2.5mg od
Prasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)
Vorapaxar: Vorapaxar will be administered at the dose of 2.5mg once daily
Ticagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)
|
DAPT
Aspirin in addition to prasugrel or ticagrelor
Prasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)
Aspirin: Aspirin will be administered at the dose of 81mg once daily
Ticagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)
|
DAPT Plus Vorapaxar
Aspirin plus prasugrel or ticagrelor plus vorapaxar 2.5mg od
Prasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)
Vorapaxar: Vorapaxar will be administered at the dose of 2.5mg once daily
Aspirin: Aspirin will be administered at the dose of 81mg once daily
Ticagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)
|
|---|---|---|---|
|
Overall Study
STARTED
|
43
|
43
|
44
|
|
Overall Study
COMPLETED
|
40
|
39
|
38
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
6
|
Reasons for withdrawal
| Measure |
Prasugrel/Ticagrelor Plus Vorapaxar
Prasugrel or ticagrelor plus vorapaxar 2.5mg od
Prasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)
Vorapaxar: Vorapaxar will be administered at the dose of 2.5mg once daily
Ticagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)
|
DAPT
Aspirin in addition to prasugrel or ticagrelor
Prasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)
Aspirin: Aspirin will be administered at the dose of 81mg once daily
Ticagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)
|
DAPT Plus Vorapaxar
Aspirin plus prasugrel or ticagrelor plus vorapaxar 2.5mg od
Prasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)
Vorapaxar: Vorapaxar will be administered at the dose of 2.5mg once daily
Aspirin: Aspirin will be administered at the dose of 81mg once daily
Ticagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
Baseline Characteristics
Vorapaxar in Patients With Prior Myocardial Infarction Treated With Prasugrel and Ticagrelor
Baseline characteristics by cohort
| Measure |
DAPT Plus Vorapaxar
n=44 Participants
Aspirin plus prasugrel or ticagrelor plus vorapaxar 2.5mg od
Prasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)
Vorapaxar: Vorapaxar will be administered at the dose of 2.5mg once daily
Aspirin: Aspirin will be administered at the dose of 81mg once daily
Ticagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)
|
Prasugrel/Ticagrelor Plus Vorapaxar
n=43 Participants
Prasugrel or ticagrelor plus vorapaxar 2.5mg od
Prasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)
Vorapaxar: Vorapaxar will be administered at the dose of 2.5mg once daily
Ticagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)
|
DAPT
n=43 Participants
Aspirin in addition to prasugrel or ticagrelor
Prasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)
Aspirin: Aspirin will be administered at the dose of 81mg once daily
Ticagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 9 • n=5 Participants
|
56 years
STANDARD_DEVIATION 9 • n=7 Participants
|
56 years
STANDARD_DEVIATION 10 • n=5 Participants
|
56 years
STANDARD_DEVIATION 10 • n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
91 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
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
79 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
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
44 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
130 Participants
n=4 Participants
|
|
Diabetes mellitus
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: 130 patients were randomized and exposed to at least one dose of study medication (triple therapy, n=44; dual therapy, n= 43; DAPT, n=43). Of these, 115 patients (triple therapy, n=37; dual therapy, n= 39; DAPT, n=39) had valid primary endpoint data
The primary end point of our study is the comparison of maximal platelet aggregation measured by light transmittance aggregometry using CAT (collagen-ADP-TRAP) between DAPT and DAPT plus vorapaxar after 30 days of treatment.
Outcome measures
| Measure |
DAPT Plus Vorapaxar
n=37 Participants
Aspirin plus prasugrel or ticagrelor plus vorapaxar 2.5mg od
Prasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)
Vorapaxar: Vorapaxar will be administered at the dose of 2.5mg once daily
Aspirin: Aspirin will be administered at the dose of 81mg once daily
Ticagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)
|
Prasugrel/Ticagrelor Plus Vorapaxar
n=39 Participants
Prasugrel or ticagrelor plus vorapaxar 2.5mg od
Prasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)
Vorapaxar: Vorapaxar will be administered at the dose of 2.5mg once daily
Ticagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)
|
DAPT
n=39 Participants
Aspirin in addition to prasugrel or ticagrelor
Prasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)
Aspirin: Aspirin will be administered at the dose of 81mg once daily
Ticagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)
|
|---|---|---|---|
|
Maximal Platelet Aggregation
|
52 percent aggregation
Standard Deviation 21
|
64 percent aggregation
Standard Deviation 20
|
74 percent aggregation
Standard Deviation 10
|
Adverse Events
DAPT Plus Vorapaxar
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Prasugrel/Ticagrelor Plus Vorapaxar
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
DAPT
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DAPT Plus Vorapaxar
n=44 participants at risk
Aspirin plus prasugrel or ticagrelor plus vorapaxar 2.5mg od
Prasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)
Vorapaxar: Vorapaxar will be administered at the dose of 2.5mg once daily
Aspirin: Aspirin will be administered at the dose of 81mg once daily
Ticagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)
|
Prasugrel/Ticagrelor Plus Vorapaxar
n=43 participants at risk
Prasugrel or ticagrelor plus vorapaxar 2.5mg od
Prasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)
Vorapaxar: Vorapaxar will be administered at the dose of 2.5mg once daily
Ticagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)
|
DAPT
n=43 participants at risk
Aspirin in addition to prasugrel or ticagrelor
Prasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)
Aspirin: Aspirin will be administered at the dose of 81mg once daily
Ticagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
BARC 1 bleeding
|
13.6%
6/44 • Number of events 6 • Duration of the study (30 days)
|
2.3%
1/43 • Number of events 1 • Duration of the study (30 days)
|
0.00%
0/43 • Duration of the study (30 days)
|
|
Cardiac disorders
chest pain
|
0.00%
0/44 • Duration of the study (30 days)
|
0.00%
0/43 • Duration of the study (30 days)
|
9.3%
4/43 • Duration of the study (30 days)
|
|
Gastrointestinal disorders
diarrhea
|
2.3%
1/44 • Duration of the study (30 days)
|
4.7%
2/43 • Duration of the study (30 days)
|
0.00%
0/43 • Duration of the study (30 days)
|
|
General disorders
dizziness
|
2.3%
1/44 • Duration of the study (30 days)
|
4.7%
2/43 • Duration of the study (30 days)
|
0.00%
0/43 • Duration of the study (30 days)
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
2.3%
1/44 • Duration of the study (30 days)
|
2.3%
1/43 • Duration of the study (30 days)
|
0.00%
0/43 • Duration of the study (30 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place