Trial Outcomes & Findings for Tailoring P2Y12 Inhibiting Therapy in Patients Requiring Oral Anticoagulation After PCI (NCT NCT04483583)
NCT ID: NCT04483583
Last Updated: 2025-07-31
Results Overview
The primary end point of our study will be levels of platelet reactivity, measured as P2Y12 reaction units (PRU) using the VerifyNow system of ticagrelor versus clopidogrel in patients with an ABCD-Gene score ≥10. A PRU \>208 suggests high platelet reactivity, while \<85 may indicate increased bleeding risk.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
81 participants
Primary outcome timeframe
30 days
Results posted on
2025-07-31
Participant Flow
There were no wash out or run-in periods.
Participant milestones
| Measure |
ABCD-GENE >10 - Clopidogrel
Patients with an ABCD-GENE\>10 score will be randomized in a 1:1 fashion to ticagrelor (60 mg/bid) or clopidogrel (75 mg/qd). Treatment will be maintained for 30 days.
|
ABCD-GENE >10 - Ticagrelor
Patients with an ABCD-GENE\>10 score will be randomized in a 1:1 fashion to ticagrelor (60 mg/bid) or clopidogrel (75 mg/qd). Treatment will be maintained for 30 days.
|
ABCD-GENE <10 - Clopidogrel
Patients with an ABCD-GENE\<10 will be treated with clopidogrel (75 mg/qd) for 30 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
19
|
42
|
|
Overall Study
COMPLETED
|
20
|
14
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
5
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
count (%)
Baseline characteristics by cohort
| Measure |
ABCD-GENE >10 - Clopidogrel
n=20 Participants
Patients with an ABCD-GENE\>10 score will be randomized in a 1:1 fashion to ticagrelor (60 mg/bid) or clopidogrel (75 mg/qd). Treatment will be maintained for 30 days.
|
ABCD-GENE >10 - Ticagrelor
n=19 Participants
Patients with an ABCD-GENE\>10 score will be randomized in a 1:1 fashion to ticagrelor (60 mg/bid) or clopidogrel (75 mg/qd). Treatment will be maintained for 30 days.
|
ABCD-GENE <10 - Clopidogrel
n=42 Participants
Patients with an ABCD-GENE\<10 will be treated with clopidogrel (75 mg/qd) for 30 days.
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
74.1 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
74.2 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
70.1 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
72 years
STANDARD_DEVIATION 8.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants • count (%)
|
8 Participants
n=7 Participants • count (%)
|
5 Participants
n=5 Participants • count (%)
|
21 Participants
n=4 Participants • count (%)
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants • count (%)
|
11 Participants
n=7 Participants • count (%)
|
37 Participants
n=5 Participants • count (%)
|
60 Participants
n=4 Participants • count (%)
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • count (%)
|
0 Participants
n=7 Participants • count (%)
|
0 Participants
n=5 Participants • count (%)
|
0 Participants
n=4 Participants • count (%)
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants • count (%)
|
1 Participants
n=7 Participants • count (%)
|
0 Participants
n=5 Participants • count (%)
|
3 Participants
n=4 Participants • count (%)
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • count (%)
|
0 Participants
n=7 Participants • count (%)
|
0 Participants
n=5 Participants • count (%)
|
0 Participants
n=4 Participants • count (%)
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants • count (%)
|
4 Participants
n=7 Participants • count (%)
|
3 Participants
n=5 Participants • count (%)
|
10 Participants
n=4 Participants • count (%)
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants • count (%)
|
14 Participants
n=7 Participants • count (%)
|
39 Participants
n=5 Participants • count (%)
|
68 Participants
n=4 Participants • count (%)
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • count (%)
|
0 Participants
n=7 Participants • count (%)
|
0 Participants
n=5 Participants • count (%)
|
0 Participants
n=4 Participants • count (%)
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • count (%)
|
0 Participants
n=7 Participants • count (%)
|
0 Participants
n=5 Participants • count (%)
|
0 Participants
n=4 Participants • count (%)
|
|
PCI indication
Stable Ischemic Heart Disease
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
PCI indication
Unstable angina
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
PCI indication
Non-ST-Segment Elevation Myocardial Infarction
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
PCI indication
ST-elevation myocardial infarction
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 30 daysThe primary end point of our study will be levels of platelet reactivity, measured as P2Y12 reaction units (PRU) using the VerifyNow system of ticagrelor versus clopidogrel in patients with an ABCD-Gene score ≥10. A PRU \>208 suggests high platelet reactivity, while \<85 may indicate increased bleeding risk.
Outcome measures
| Measure |
ABCD-GENE >10 - Clopidogrel
n=20 Participants
Patients with an ABCD-GENE\>10 score will be randomized in a 1:1 fashion to ticagrelor (60 mg/bid) or clopidogrel (75 mg/qd). Treatment will be maintained for 30 days.
|
ABCD-GENE >10 - Ticagrelor
n=14 Participants
Patients with an ABCD-GENE\>10 score will be randomized in a 1:1 fashion to ticagrelor (60 mg/bid) or clopidogrel (75 mg/qd). Treatment will be maintained for 30 days.
|
ABCD-GENE <10 - Clopidogrel
n=35 Participants
Patients with an ABCD-GENE\<10 will be treated with clopidogrel (75 mg/qd) for 30 days.
|
|---|---|---|---|
|
Platelet Reactivity Measured as PRU
|
154.5 PRU
Interval 77.5 to 183.5
|
23 PRU
Interval 3.0 to 46.0
|
104 PRU
Interval 35.0 to 167.0
|
Adverse Events
ABCD-GENE >10 - Clopidogrel
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
ABCD-GENE >10 - Ticagrelor
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
ABCD-GENE <10 - Clopidogrel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ABCD-GENE >10 - Clopidogrel
n=20 participants at risk
Patients with an ABCD-GENE\>10 score will be randomized in a 1:1 fashion to ticagrelor (60 mg/bid) or clopidogrel (75 mg/qd). Treatment will be maintained for 30 days.
|
ABCD-GENE >10 - Ticagrelor
n=20 participants at risk
Patients with an ABCD-GENE\>10 score will be randomized in a 1:1 fashion to ticagrelor (60 mg/bid) or clopidogrel (75 mg/qd). Treatment will be maintained for 30 days.
|
ABCD-GENE <10 - Clopidogrel
n=42 participants at risk
Patients with an ABCD-GENE\<10 will be treated with clopidogrel (75 mg/qd) for 30 days.
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
5.0%
1/20 • Number of events 1 • 30 days
Our definition of adverse event and/or serious adverse event did not differ from the one of clinicaltrials.gov
|
0.00%
0/20 • 30 days
Our definition of adverse event and/or serious adverse event did not differ from the one of clinicaltrials.gov
|
0.00%
0/42 • 30 days
Our definition of adverse event and/or serious adverse event did not differ from the one of clinicaltrials.gov
|
Other adverse events
| Measure |
ABCD-GENE >10 - Clopidogrel
n=20 participants at risk
Patients with an ABCD-GENE\>10 score will be randomized in a 1:1 fashion to ticagrelor (60 mg/bid) or clopidogrel (75 mg/qd). Treatment will be maintained for 30 days.
|
ABCD-GENE >10 - Ticagrelor
n=20 participants at risk
Patients with an ABCD-GENE\>10 score will be randomized in a 1:1 fashion to ticagrelor (60 mg/bid) or clopidogrel (75 mg/qd). Treatment will be maintained for 30 days.
|
ABCD-GENE <10 - Clopidogrel
n=42 participants at risk
Patients with an ABCD-GENE\<10 will be treated with clopidogrel (75 mg/qd) for 30 days.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Drug-induced dyspnea
|
0.00%
0/20 • 30 days
Our definition of adverse event and/or serious adverse event did not differ from the one of clinicaltrials.gov
|
35.0%
7/20 • Number of events 7 • 30 days
Our definition of adverse event and/or serious adverse event did not differ from the one of clinicaltrials.gov
|
0.00%
0/42 • 30 days
Our definition of adverse event and/or serious adverse event did not differ from the one of clinicaltrials.gov
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place