Trial Outcomes & Findings for Downstream Molecular Signals of P2Y12 Receptors in Hyporeactive Patients Under Clopidogrel Treatment A Possible Mechanism of HOTPR(High On-Treatment Platelet Reactivity) (NCT NCT03190005)
NCT ID: NCT03190005
Last Updated: 2019-11-21
Results Overview
PRU(Platelet Rreactivity Unit) 24 hours after DAPT(Dual AntiPlatelet Therapy) Western blot after medication
Recruitment status
COMPLETED
Target enrollment
35 participants
Primary outcome timeframe
24 hours
Results posted on
2019-11-21
Participant Flow
Participant milestones
| Measure |
Group 1
placebo control without medication.
Placebos: no medication, healthy subjects.
|
Group 2
hyper-reactive responser after clopidogrel.
clopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)
|
Group 3
hypo-reactive responser after clopidogrel.
clopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)
|
Group 4
normo-reactive responser after clopidogrel.
clopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)
|
Group 5
reaction after OPC-13013
|
Group 6
reaction after AR-C
|
Group 7
reaction after simastatin
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Downstream Molecular Signals of P2Y12 Receptors in Hyporeactive Patients Under Clopidogrel Treatment A Possible Mechanism of HOTPR(High On-Treatment Platelet Reactivity)
Baseline characteristics by cohort
| Measure |
Group 1
n=5 blood samples
placebo control without medication.
Placebos: no medication, healthy subjects.
|
Group 2
n=5 blood samples
hyper-reactive responser after clopidogrel.
clopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)
|
Group 3
n=5 blood samples
hypo-reactive responser after clopidogrel.
clopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)
|
Group 4
n=5 blood samples
normo-reactive responser after clopidogrel.
clopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)
|
Group 5
n=5 blood samples
reaction after OPC-13013
|
Group 6
n=5 blood samples
reaction after AR-C
|
Group 7
n=5 blood samples
reaction after simastatin
|
Total
n=35 blood samples
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
20 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
15 Participants
n=6 Participants
|
|
Age, Continuous
|
62.52 years
STANDARD_DEVIATION 11.12 • n=5 Participants
|
64.92 years
STANDARD_DEVIATION 13.24 • n=7 Participants
|
66.89 years
STANDARD_DEVIATION 10.72 • n=5 Participants
|
63.35 years
STANDARD_DEVIATION 13.62 • n=4 Participants
|
65.09 years
STANDARD_DEVIATION 11.13 • n=21 Participants
|
61.23 years
STANDARD_DEVIATION 10.34 • n=10 Participants
|
68.32 years
STANDARD_DEVIATION 15.12 • n=115 Participants
|
67.36 years
STANDARD_DEVIATION 13.82 • n=6 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
13 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
22 Participants
n=6 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
35 Participants
n=6 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Region of Enrollment
Taiwan
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
5 participants
n=4 Participants
|
5 participants
n=21 Participants
|
5 participants
n=10 Participants
|
5 participants
n=115 Participants
|
5 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: PRU(Platelet Rreactivity Unit) 24 hours after DAPT(Dual AntiPlatelet Therapy) Western blot after medication
PRU(Platelet Rreactivity Unit) 24 hours after DAPT(Dual AntiPlatelet Therapy) Western blot after medication
Outcome measures
| Measure |
Group 1
n=5 blood sample
placebo control without medication.
Placebos: no medication, healthy subjects.
|
Group 2
n=5 blood sample
hyper-reactive responser after clopidogrel.
clopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)
|
Group 3
n=5 blood sample
hypo-reactive responser after clopidogrel.
clopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)
|
Group 4
n=5 blood sample
normo-reactive responser after clopidogrel.
clopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)
|
Group 5
n=5 blood sample
reaction after OPC-13013
clopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)
|
Group 6
n=5 blood sample
reaction after AR-C
clopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)
|
Group 7
n=5 blood sample
reaction after simastatin
clopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)
|
|---|---|---|---|---|---|---|---|
|
PRU(Platelet Rreactivity Unit) 24 Hours After DAPT(Dual AntiPlatelet Therapy) Western Blot After Medication
|
148 PRU(Platelet Rreactivity Unit)
Standard Deviation 3
|
289 PRU(Platelet Rreactivity Unit)
Standard Deviation 4
|
79 PRU(Platelet Rreactivity Unit)
Standard Deviation 1
|
132 PRU(Platelet Rreactivity Unit)
Standard Deviation 6
|
81 PRU(Platelet Rreactivity Unit)
Standard Deviation 3
|
62 PRU(Platelet Rreactivity Unit)
Standard Deviation 2
|
114 PRU(Platelet Rreactivity Unit)
Standard Deviation 9
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 5
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 6
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 7
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place