Trial Outcomes & Findings for Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease (NCT NCT04006288)
NCT ID: NCT04006288
Last Updated: 2023-04-26
Results Overview
The primary end point of this study will be the comparison of MPA% measured by LTA using the CATF cocktail as agonist between DAPT and low-dose rivaroxaban plus aspirin for each DAPT regimen
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
90 participants
Primary outcome timeframe
30 days
Results posted on
2023-04-26
Participant Flow
Patients treated with either aspirin (81mg/qd) plus clopidogrel, aspirin (81mg/qd) plus ticagrelor (90mg/bid), or aspirin (81mg/qd) plus prasugrel (10mg/bid) were identified. Each cohort was randomized 1:1 to either maintain DAPT or to DPI. DPI consists in treatment with aspirin (81mg/qd) plus rivaroxaban (2.5mg/bid). Patients randomized to DAPT will continue their guideline recommended DAPT regimens.
Participant milestones
| Measure |
Aspirin and Clopidogrel
aspirin 81 mg/qd plus clopidogrel 75mg/qd for 30 days
Clopidogrel: Patients on aspirin and plavix will be randomized to either continue with aspirin and plavix or to switch to aspirin and rivaroxaban
aspirin: all patients will remain on aspirin
|
Aspirin and Rivaroxaban From Aspirin and Clopidogrel
aspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days
aspirin: all patients will remain on aspirin
rivaroxaban: Patients on DAPT will be randomized to either continue with DAPT or to switch to aspirin and rivaroxaban
|
Aspirin and Prasugrel
aspirin 81 mg/qd plus prasugrel 10mg/qd for 30 days
Prasugrel: Patients on aspirin and prasugrel will be randomized to either continue with aspirin and prasugrel or to switch to aspirin and rivaroxaban
aspirin: all patients will remain on aspirin
|
Aspirin and Rivaroxaban From Aspirin and Prasugrel
aspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days
aspirin: all patients will remain on aspirin
rivaroxaban: Patients on DAPT will be randomized to either continue with DAPT or to switch to aspirin and rivaroxaban
|
Aspirin and Ticagrelor
aspirin 81 mg/qd plus ticagrelor 60mg/bid for 30 days
ticagrelor: Patients on aspirin and ticagrelor will be randomized to either continue with aspirin and ticagrelor or to switch to aspirin and rivaroxaban
aspirin: all patients will remain on aspirin
|
Aspirin and Rivaroxaban From Aspirin and Ticagrelor
aspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days
aspirin: all patients will remain on aspirin
rivaroxaban: Patients on DAPT will be randomized to either continue with DAPT or to switch to aspirin and rivaroxaban
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
14
|
15
|
15
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease
Baseline characteristics by cohort
| Measure |
Aspirin and Clopidogrel
n=15 Participants
aspirin 81 mg/qd plus clopidogrel 75mg/qd for 30 days
Clopidogrel: Patients on aspirin and plavix will be randomized to either continue with aspirin and plavix or to switch to aspirin and rivaroxaban
aspirin: all patients will remain on aspirin
|
Aspirin and Rivaroxaban From Aspirin and Clopidogrel
n=15 Participants
aspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days
aspirin: all patients will remain on aspirin
rivaroxaban: Patients on DAPT will be randomized to either continue with DAPT or to switch to aspirin and rivaroxaban
|
Aspirin and Prasugrel
n=15 Participants
aspirin 81 mg/qd plus prasugrel 10mg/qd for 30 days
Prasugrel: Patients on aspirin and prasugrel will be randomized to either continue with aspirin and prasugrel or to switch to aspirin and rivaroxaban
aspirin: all patients will remain on aspirin
|
Aspirin and Rivaroxaban From Aspirin and Prasugrel
n=15 Participants
aspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days
aspirin: all patients will remain on aspirin
rivaroxaban: Patients on DAPT will be randomized to either continue with DAPT or to switch to aspirin and rivaroxaban
|
Aspirin and Ticagrelor
n=15 Participants
aspirin 81 mg/qd plus ticagrelor 60mg/bid for 30 days
ticagrelor: Patients on aspirin and ticagrelor will be randomized to either continue with aspirin and ticagrelor or to switch to aspirin and rivaroxaban
aspirin: all patients will remain on aspirin
|
Aspirin and Rivaroxaban From Aspirin and Ticagrelor
n=15 Participants
aspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days
aspirin: all patients will remain on aspirin
rivaroxaban: Patients on DAPT will be randomized to either continue with DAPT or to switch to aspirin and rivaroxaban
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
63.4 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
64.1 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
61.1 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
61.1 years
STANDARD_DEVIATION 9.0 • n=4 Participants
|
56.5 years
STANDARD_DEVIATION 8.8 • n=21 Participants
|
60.9 years
STANDARD_DEVIATION 9.4 • n=8 Participants
|
61.3 years
STANDARD_DEVIATION 8.4 • n=8 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
60 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
30 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
28 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
61 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
90 Participants
n=8 Participants
|
|
Diabetes mellitus
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
54 Participants
n=8 Participants
|
|
Previous percutaneous coronary intervention
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
85 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 30 daysThe primary end point of this study will be the comparison of MPA% measured by LTA using the CATF cocktail as agonist between DAPT and low-dose rivaroxaban plus aspirin for each DAPT regimen
Outcome measures
| Measure |
Aspirin and Clopidogrel
n=14 Participants
aspirin 81 mg/qd plus clopidogrel 75mg/qd for 30 days
Clopidogrel: Patients on aspirin and plavix will be randomized to either continue with aspirin and plavix or to switch to aspirin and rivaroxaban
aspirin: all patients will remain on aspirin
|
Aspirin and Rivaroxaban From Aspirin and Clopidogrel
n=14 Participants
aspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days
aspirin: all patients will remain on aspirin
rivaroxaban: Patients on DAPT will be randomized to either continue with DAPT or to switch to aspirin and rivaroxaban
|
Aspirin and Prasugrel
n=15 Participants
aspirin 81 mg/qd plus prasugrel 10mg/qd for 30 days
Prasugrel: Patients on aspirin and prasugrel will be randomized to either continue with aspirin and prasugrel or to switch to aspirin and rivaroxaban
aspirin: all patients will remain on aspirin
|
Aspirin and Rivaroxaban From Aspirin and Prasugrel
n=15 Participants
aspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days
aspirin: all patients will remain on aspirin
rivaroxaban: Patients on DAPT will be randomized to either continue with DAPT or to switch to aspirin and rivaroxaban
|
Aspirin and Ticagrelor
n=15 Participants
aspirin 81 mg/qd plus ticagrelor 60mg/bid for 30 days
ticagrelor: Patients on aspirin and ticagrelor will be randomized to either continue with aspirin and ticagrelor or to switch to aspirin and rivaroxaban
aspirin: all patients will remain on aspirin
|
Aspirin and Rivaroxaban From Aspirin and Ticagrelor
n=15 Participants
aspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days
aspirin: all patients will remain on aspirin
rivaroxaban: Patients on DAPT will be randomized to either continue with DAPT or to switch to aspirin and rivaroxaban
|
|---|---|---|---|---|---|---|
|
Maximal Platelet Aggregation (MPA%) by Light Transmittance Aggregometry (LTA)
|
27 percentage of MPA
Interval 17.0 to 50.0
|
53 percentage of MPA
Interval 43.0 to 66.0
|
20 percentage of MPA
Interval 4.0 to 37.0
|
4 percentage of MPA
Interval 0.0 to 17.0
|
15 percentage of MPA
Interval 1.0 to 33.0
|
20 percentage of MPA
Interval 6.0 to 50.0
|
Adverse Events
Aspirin and Clopidogrel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aspirin and Rivaroxaban From Aspirin and Clopidogrel
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Aspirin and Prasugrel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aspirin and Rivaroxaban From Aspirin and Prasugrel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aspirin and Ticagrelor
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aspirin and Rivaroxaban From Aspirin and Ticagrelor
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Aspirin and Clopidogrel
n=15 participants at risk
aspirin 81 mg/qd plus clopidogrel 75mg/qd for 30 days
Clopidogrel: Patients on aspirin and plavix will be randomized to either continue with aspirin and plavix or to switch to aspirin and rivaroxaban
aspirin: all patients will remain on aspirin
|
Aspirin and Rivaroxaban From Aspirin and Clopidogrel
n=15 participants at risk
aspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days
aspirin: all patients will remain on aspirin
rivaroxaban: Patients on DAPT will be randomized to either continue with DAPT or to switch to aspirin and rivaroxaban
|
Aspirin and Prasugrel
n=15 participants at risk
aspirin 81 mg/qd plus prasugrel 10mg/qd for 30 days
Prasugrel: Patients on aspirin and prasugrel will be randomized to either continue with aspirin and prasugrel or to switch to aspirin and rivaroxaban
aspirin: all patients will remain on aspirin
|
Aspirin and Rivaroxaban From Aspirin and Prasugrel
n=15 participants at risk
aspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days
aspirin: all patients will remain on aspirin
rivaroxaban: Patients on DAPT will be randomized to either continue with DAPT or to switch to aspirin and rivaroxaban
|
Aspirin and Ticagrelor
n=15 participants at risk
aspirin 81 mg/qd plus ticagrelor 60mg/bid for 30 days
ticagrelor: Patients on aspirin and ticagrelor will be randomized to either continue with aspirin and ticagrelor or to switch to aspirin and rivaroxaban
aspirin: all patients will remain on aspirin
|
Aspirin and Rivaroxaban From Aspirin and Ticagrelor
n=15 participants at risk
aspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days
aspirin: all patients will remain on aspirin
rivaroxaban: Patients on DAPT will be randomized to either continue with DAPT or to switch to aspirin and rivaroxaban
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Bleeding
|
0.00%
0/15 • At 30 days.
Ischemic and bleeding according to the Bleeding Academic Research Consortium (BARC) definition.
|
6.7%
1/15 • Number of events 1 • At 30 days.
Ischemic and bleeding according to the Bleeding Academic Research Consortium (BARC) definition.
|
0.00%
0/15 • At 30 days.
Ischemic and bleeding according to the Bleeding Academic Research Consortium (BARC) definition.
|
0.00%
0/15 • At 30 days.
Ischemic and bleeding according to the Bleeding Academic Research Consortium (BARC) definition.
|
0.00%
0/15 • At 30 days.
Ischemic and bleeding according to the Bleeding Academic Research Consortium (BARC) definition.
|
0.00%
0/15 • At 30 days.
Ischemic and bleeding according to the Bleeding Academic Research Consortium (BARC) definition.
|
Additional Information
Dr. Dominick J Angiolillo. Professor of med University of Florida College of Medicine-Jacksonville
University of Florida
Phone: 904-244-3378
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place