Trial Outcomes & Findings for P3AMI Antiplatelet Trial (NCT NCT02376283)
NCT ID: NCT02376283
Last Updated: 2020-02-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
87 participants
Primary outcome timeframe
Balloon Inflation as Baseline, 20, 60, 240 minutes
Results posted on
2020-02-10
Participant Flow
Participant milestones
| Measure |
Clopidogrel
STEMI (ST-segment elevation myocardial infarction) (n = 14) and NSTEMI (Non-ST segment elevation myocardial infarction) (n = 13) patients were administered a clopidogrel 600mg loading dose and whole blood samples (15ml) for pharmacodynamic assessment of the degree of platelet inhibition were obtained. Plasma samples to allow for pharmacokinetic quantification of active metabolites were extracted from whole blood samples collected. Samples were collected at 20 minutes, 60 minutes and 240 minutes post loading. In the STEMI group an additional sample was collected at the time of angioplasty.
The participants involvement in the study ceased following the collection of the 240-minute blood sample.
|
Prasugrel
STEMI (n = 15) and NSTEMI (n = 15) patients were administered a prasugrel 90mg loading dose and whole blood samples (15ml) for pharmacodynamic assessment of the degree of platelet inhibition were obtained. Plasma samples to allow for pharmacokinetic quantification of active metabolites were extracted from whole blood samples collected. Samples were collected at 20 minutes, 60 minutes and 240 minutes post loading. In the STEMI group an additional sample was collected at the time of angioplasty.
The participants involvement in the study ceased following the collection of the 240-minute blood sample.
|
Ticagrelor
STEMI (n = 15) and NSTEMI (n = 15) patients were administered a ticagrelor 180mg loading dose and whole blood samples (15ml) for pharmacodynamic assessment of the degree of platelet inhibition and pharmacokinetic quantification of parent compound and active metabolites were collected. Samples were collected at 20 minutes, 60 minutes and 240 minutes post loading. In the STEMI group an additional sample was collected at the time of angioplasty.
The participants involvement in the study ceased following the collection of the 240-minute blood sample.
|
|---|---|---|---|
|
Overall Study
STARTED
|
27
|
30
|
30
|
|
Overall Study
COMPLETED
|
27
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Clopidogrel
n=27 Participants
STEMI (n = 14) and NSTEMI (n = 13) patients were administered a clopidogrel 600mg loading dose and whole blood samples (15ml) for pharmacodynamic assessment of the degree of platelet inhibition were obtained. Plasma samples to allow for pharmacokinetic quantification of active metabolites were extracted from whole blood samples collected. Samples were collected at 20 minutes, 60 minutes and 240 minutes post loading. In the STEMI group an additional sample was collected at the time of angioplasty.
The participants involvement in the study ceased following the collection of the 240-minute blood sample.
|
Prasugrel
n=30 Participants
STEMI (n = 15) and NSTEMI (n = 15) patients were administered a prasugrel 90mg loading dose and whole blood samples (15ml) for pharmacodynamic assessment of the degree of platelet inhibition were obtained. Plasma samples to allow for pharmacokinetic quantification of active metabolites were extracted from whole blood samples collected. Samples were collected at 20 minutes, 60 minutes and 240 minutes post loading. In the STEMI group an additional sample was collected at the time of angioplasty.
The participants involvement in the study ceased following the collection of the 240-minute blood sample.
|
Ticagrelor
n=30 Participants
STEMI (n = 15) and NSTEMI (n = 15) patients were administered a ticagrelor 180mg loading dose and whole blood samples (15ml) for pharmacodynamic assessment of the degree of platelet inhibition and pharmacokinetic quantification of parent compound and active metabolites were collected. Samples were collected at 20 minutes, 60 minutes and 240 minutes post loading. In the STEMI group an additional sample was collected at the time of angioplasty.
The participants involvement in the study ceased following the collection of the 240-minute blood sample.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=27 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=87 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=27 Participants
|
19 Participants
n=30 Participants
|
13 Participants
n=30 Participants
|
41 Participants
n=87 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=27 Participants
|
11 Participants
n=30 Participants
|
17 Participants
n=30 Participants
|
46 Participants
n=87 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=27 Participants
|
5 Participants
n=30 Participants
|
6 Participants
n=30 Participants
|
19 Participants
n=87 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=27 Participants
|
25 Participants
n=30 Participants
|
24 Participants
n=30 Participants
|
68 Participants
n=87 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
27 participants
n=27 Participants
|
30 participants
n=30 Participants
|
30 participants
n=30 Participants
|
87 participants
n=87 Participants
|
PRIMARY outcome
Timeframe: Balloon Inflation as Baseline, 20, 60, 240 minutesPopulation: The overall group consists of STEMI and NSTEMI participants -outcome measure is broken down into the time points for each specific sub-group reported separately by Row. These two categories represent a subpopulation within the Overall Number of Participants Analyzed, therefore it has been indicated how many participants were analyzed for each Row.
Outcome measures
| Measure |
Clopidogrel
n=27 Participants
STEMI (n = 14) and NSTEMI (n = 13) patients were administered a clopidogrel 600mg loading dose and whole blood samples (15ml) for pharmacodynamic assessment of the degree of platelet inhibition were obtained. Plasma samples to allow for pharmacokinetic quantification of active metabolites were extracted from whole blood samples collected. Samples were collected at 20 minutes, 60 minutes and 240 minutes post loading. In the STEMI group an additional sample was collected at the time of angioplasty.
The participants involvement in the study ceased following the collection of the 240-minute blood sample.
|
Prasugrel
n=30 Participants
STEMI (n = 15) and NSTEMI (n = 15) patients were administered a prasugrel 90mg loading dose and whole blood samples (15ml) for pharmacodynamic assessment of the degree of platelet inhibition were obtained. Plasma samples to allow for pharmacokinetic quantification of active metabolites were extracted from whole blood samples collected. Samples were collected at 20 minutes, 60 minutes and 240 minutes post loading. In the STEMI group an additional sample was collected at the time of angioplasty.
The participants involvement in the study ceased following the collection of the 240-minute blood sample.
|
Ticagrelor
n=30 Participants
STEMI (n = 15) and NSTEMI (n = 15) patients were administered a ticagrelor 180mg loading dose and whole blood samples (15ml) for pharmacodynamic assessment of the degree of platelet inhibition and pharmacokinetic quantification of parent compound and active metabolites were collected. Samples were collected at 20 minutes, 60 minutes and 240 minutes post loading. In the STEMI group an additional sample was collected at the time of angioplasty.
The participants involvement in the study ceased following the collection of the 240-minute blood sample.
|
Ticagrelor Parent Compound
STEMI/NSTEMI patients. (Ticagrelor was used in our centre only after the use of prasugrel was discontinued) The parent compound was also analysed as it is a directly acting agent that does not require metabolic conversion to its active form
|
|---|---|---|---|---|
|
Pharmacodynamic Assessment of Degree of Platelet Inhibition as Determined by Verify Now Point of Care Assay and Expressed as P2Y12 Reaction Units (PRU)
STEMI at 20 mins
|
270.23 P2Y12 reaction units (PRU)
Standard Deviation 38.56
|
247.73 P2Y12 reaction units (PRU)
Standard Deviation 48.78
|
256.73 P2Y12 reaction units (PRU)
Standard Deviation 50.81
|
—
|
|
Pharmacodynamic Assessment of Degree of Platelet Inhibition as Determined by Verify Now Point of Care Assay and Expressed as P2Y12 Reaction Units (PRU)
STEMI at balloon inflation
|
286.46 P2Y12 reaction units (PRU)
Standard Deviation 33.12
|
253.73 P2Y12 reaction units (PRU)
Standard Deviation 57.17
|
257.93 P2Y12 reaction units (PRU)
Standard Deviation 61.12
|
—
|
|
Pharmacodynamic Assessment of Degree of Platelet Inhibition as Determined by Verify Now Point of Care Assay and Expressed as P2Y12 Reaction Units (PRU)
STEMI at 60 mins
|
293.46 P2Y12 reaction units (PRU)
Standard Deviation 31.68
|
262.87 P2Y12 reaction units (PRU)
Standard Deviation 43.43
|
225.20 P2Y12 reaction units (PRU)
Standard Deviation 82.70
|
—
|
|
Pharmacodynamic Assessment of Degree of Platelet Inhibition as Determined by Verify Now Point of Care Assay and Expressed as P2Y12 Reaction Units (PRU)
STEMI at 240 mins
|
226.42 P2Y12 reaction units (PRU)
Standard Deviation 69.44
|
128.64 P2Y12 reaction units (PRU)
Standard Deviation 89.16
|
176.27 P2Y12 reaction units (PRU)
Standard Deviation 84.92
|
—
|
|
Pharmacodynamic Assessment of Degree of Platelet Inhibition as Determined by Verify Now Point of Care Assay and Expressed as P2Y12 Reaction Units (PRU)
NSTEMI at 20 mins
|
213.21 P2Y12 reaction units (PRU)
Standard Deviation 51.74
|
125.80 P2Y12 reaction units (PRU)
Standard Deviation 89.34
|
172.80 P2Y12 reaction units (PRU)
Standard Deviation 92.54
|
—
|
|
Pharmacodynamic Assessment of Degree of Platelet Inhibition as Determined by Verify Now Point of Care Assay and Expressed as P2Y12 Reaction Units (PRU)
NSTEMI at 60 mins
|
227.36 P2Y12 reaction units (PRU)
Standard Deviation 61.19
|
76.93 P2Y12 reaction units (PRU)
Standard Deviation 99.24
|
114.20 P2Y12 reaction units (PRU)
Standard Deviation 122.22
|
—
|
|
Pharmacodynamic Assessment of Degree of Platelet Inhibition as Determined by Verify Now Point of Care Assay and Expressed as P2Y12 Reaction Units (PRU)
NSTEMI at 240 mins
|
214.00 P2Y12 reaction units (PRU)
Standard Deviation 69.98
|
31.87 P2Y12 reaction units (PRU)
Standard Deviation 45.52
|
23.00 P2Y12 reaction units (PRU)
Standard Deviation 18.94
|
—
|
PRIMARY outcome
Timeframe: Balloon Inflation as Baseline, 20, 60, 240 minutesPopulation: The overall group consists of STEMI and NSTEMI participants -outcome measure is broken down into the time points for each specific sub-group reported separately by Row. These two categories represent a subpopulation within the Overall Number of Participants Analyzed, therefore it has been indicated how many participants were analyzed for each Row.
The parent compound of Ticagrelor was also analysed within the same patient group of Ticagrelor as it is a directly acting agent that does not require metabolic conversion to its active form.
Outcome measures
| Measure |
Clopidogrel
n=27 Participants
STEMI (n = 14) and NSTEMI (n = 13) patients were administered a clopidogrel 600mg loading dose and whole blood samples (15ml) for pharmacodynamic assessment of the degree of platelet inhibition were obtained. Plasma samples to allow for pharmacokinetic quantification of active metabolites were extracted from whole blood samples collected. Samples were collected at 20 minutes, 60 minutes and 240 minutes post loading. In the STEMI group an additional sample was collected at the time of angioplasty.
The participants involvement in the study ceased following the collection of the 240-minute blood sample.
|
Prasugrel
n=30 Participants
STEMI (n = 15) and NSTEMI (n = 15) patients were administered a prasugrel 90mg loading dose and whole blood samples (15ml) for pharmacodynamic assessment of the degree of platelet inhibition were obtained. Plasma samples to allow for pharmacokinetic quantification of active metabolites were extracted from whole blood samples collected. Samples were collected at 20 minutes, 60 minutes and 240 minutes post loading. In the STEMI group an additional sample was collected at the time of angioplasty.
The participants involvement in the study ceased following the collection of the 240-minute blood sample.
|
Ticagrelor
n=30 Participants
STEMI (n = 15) and NSTEMI (n = 15) patients were administered a ticagrelor 180mg loading dose and whole blood samples (15ml) for pharmacodynamic assessment of the degree of platelet inhibition and pharmacokinetic quantification of parent compound and active metabolites were collected. Samples were collected at 20 minutes, 60 minutes and 240 minutes post loading. In the STEMI group an additional sample was collected at the time of angioplasty.
The participants involvement in the study ceased following the collection of the 240-minute blood sample.
|
Ticagrelor Parent Compound
n=30 Participants
STEMI/NSTEMI patients. (Ticagrelor was used in our centre only after the use of prasugrel was discontinued) The parent compound was also analysed as it is a directly acting agent that does not require metabolic conversion to its active form
|
|---|---|---|---|---|
|
Pharmacokinetic Quantification of Plasma Concentration of Clopidogrel and Prasugrel Active Metabolite and Ticagrelor Parent Compound and Active Metabolite Assessed Using Liquid Chromatography in Tandem With Mass Spectrometry (LC-MS/MS) Expressed as ng/ml
STEMI at 20 mins
|
39.12 ng/ml
Standard Error 16.17
|
14.27 ng/ml
Standard Error 8.80
|
0.16 ng/ml
Standard Error 0.16
|
9.04 ng/ml
Standard Error 4.12
|
|
Pharmacokinetic Quantification of Plasma Concentration of Clopidogrel and Prasugrel Active Metabolite and Ticagrelor Parent Compound and Active Metabolite Assessed Using Liquid Chromatography in Tandem With Mass Spectrometry (LC-MS/MS) Expressed as ng/ml
STEMI at balloon inflation
|
107.83 ng/ml
Standard Error 44.08
|
24.20 ng/ml
Standard Error 13.07
|
1.64 ng/ml
Standard Error 1.17
|
28.56 ng/ml
Standard Error 12.58
|
|
Pharmacokinetic Quantification of Plasma Concentration of Clopidogrel and Prasugrel Active Metabolite and Ticagrelor Parent Compound and Active Metabolite Assessed Using Liquid Chromatography in Tandem With Mass Spectrometry (LC-MS/MS) Expressed as ng/ml
STEMI at 60 mins
|
71.02 ng/ml
Standard Error 27.21
|
36.86 ng/ml
Standard Error 13.27
|
14.43 ng/ml
Standard Error 7.28
|
47.13 ng/ml
Standard Error 24.09
|
|
Pharmacokinetic Quantification of Plasma Concentration of Clopidogrel and Prasugrel Active Metabolite and Ticagrelor Parent Compound and Active Metabolite Assessed Using Liquid Chromatography in Tandem With Mass Spectrometry (LC-MS/MS) Expressed as ng/ml
STEMI at 240 mins
|
32.41 ng/ml
Standard Error 6.71
|
38.44 ng/ml
Standard Error 7.59
|
53.38 ng/ml
Standard Error 25.21
|
84.92 ng/ml
Standard Error 42.00
|
|
Pharmacokinetic Quantification of Plasma Concentration of Clopidogrel and Prasugrel Active Metabolite and Ticagrelor Parent Compound and Active Metabolite Assessed Using Liquid Chromatography in Tandem With Mass Spectrometry (LC-MS/MS) Expressed as ng/ml
NSTEMI at 20 mins
|
41.99 ng/ml
Standard Error 25.27
|
515.80 ng/ml
Standard Error 126.84
|
7.72 ng/ml
Standard Error 5.10
|
22.78 ng/ml
Standard Error 10.27
|
|
Pharmacokinetic Quantification of Plasma Concentration of Clopidogrel and Prasugrel Active Metabolite and Ticagrelor Parent Compound and Active Metabolite Assessed Using Liquid Chromatography in Tandem With Mass Spectrometry (LC-MS/MS) Expressed as ng/ml
NSTEMI at 60 mins
|
93.35 ng/ml
Standard Error 49.65
|
194.59 ng/ml
Standard Error 29.97
|
58.40 ng/ml
Standard Error 25.41
|
84.13 ng/ml
Standard Error 34.02
|
|
Pharmacokinetic Quantification of Plasma Concentration of Clopidogrel and Prasugrel Active Metabolite and Ticagrelor Parent Compound and Active Metabolite Assessed Using Liquid Chromatography in Tandem With Mass Spectrometry (LC-MS/MS) Expressed as ng/ml
NSTEMI at 240 mins
|
27.71 ng/ml
Standard Error 6.90
|
36.80 ng/ml
Standard Error 4.59
|
113.59 ng/ml
Standard Error 19.20
|
140.61 ng/ml
Standard Error 36.31
|
SECONDARY outcome
Timeframe: Balloon Inflation as Baseline, 20, 60, 240 minutesPopulation: The overall group consists of STEMI and NSTEMI participants -outcome measure is broken down into the time points for each specific sub-group reported separately by Row. These two categories represent a subpopulation within the Overall Number of Participants Analyzed, therefore it has been indicated how many participants were analyzed for each Row.
Outcome measures
| Measure |
Clopidogrel
n=27 Participants
STEMI (n = 14) and NSTEMI (n = 13) patients were administered a clopidogrel 600mg loading dose and whole blood samples (15ml) for pharmacodynamic assessment of the degree of platelet inhibition were obtained. Plasma samples to allow for pharmacokinetic quantification of active metabolites were extracted from whole blood samples collected. Samples were collected at 20 minutes, 60 minutes and 240 minutes post loading. In the STEMI group an additional sample was collected at the time of angioplasty.
The participants involvement in the study ceased following the collection of the 240-minute blood sample.
|
Prasugrel
n=30 Participants
STEMI (n = 15) and NSTEMI (n = 15) patients were administered a prasugrel 90mg loading dose and whole blood samples (15ml) for pharmacodynamic assessment of the degree of platelet inhibition were obtained. Plasma samples to allow for pharmacokinetic quantification of active metabolites were extracted from whole blood samples collected. Samples were collected at 20 minutes, 60 minutes and 240 minutes post loading. In the STEMI group an additional sample was collected at the time of angioplasty.
The participants involvement in the study ceased following the collection of the 240-minute blood sample.
|
Ticagrelor
n=30 Participants
STEMI (n = 15) and NSTEMI (n = 15) patients were administered a ticagrelor 180mg loading dose and whole blood samples (15ml) for pharmacodynamic assessment of the degree of platelet inhibition and pharmacokinetic quantification of parent compound and active metabolites were collected. Samples were collected at 20 minutes, 60 minutes and 240 minutes post loading. In the STEMI group an additional sample was collected at the time of angioplasty.
The participants involvement in the study ceased following the collection of the 240-minute blood sample.
|
Ticagrelor Parent Compound
STEMI/NSTEMI patients. (Ticagrelor was used in our centre only after the use of prasugrel was discontinued) The parent compound was also analysed as it is a directly acting agent that does not require metabolic conversion to its active form
|
|---|---|---|---|---|
|
Pharmacodynamic Assessment of Degree of Platelet Inhibition as Determined by VASP (Vasodilator Stimulated Phosphoprotein Phosphorylation) Flow Cytometry and Expressed as %PRI (Platelet Reactivity Index)
STEMI at 60 mins
|
71.57 %PRI
Standard Deviation 11.68
|
50.50 %PRI
Standard Deviation 11.88
|
76.25 %PRI
Standard Deviation 11.12
|
—
|
|
Pharmacodynamic Assessment of Degree of Platelet Inhibition as Determined by VASP (Vasodilator Stimulated Phosphoprotein Phosphorylation) Flow Cytometry and Expressed as %PRI (Platelet Reactivity Index)
STEMI at 20 mins
|
76.29 %PRI
Standard Deviation 8.77
|
46.25 %PRI
Standard Deviation 13.91
|
79.75 %PRI
Standard Deviation 9.20
|
—
|
|
Pharmacodynamic Assessment of Degree of Platelet Inhibition as Determined by VASP (Vasodilator Stimulated Phosphoprotein Phosphorylation) Flow Cytometry and Expressed as %PRI (Platelet Reactivity Index)
STEMI at balloon inflation
|
74.86 %PRI
Standard Deviation 9.00
|
41.13 %PRI
Standard Deviation 12.71
|
74.63 %PRI
Standard Deviation 11.42
|
—
|
|
Pharmacodynamic Assessment of Degree of Platelet Inhibition as Determined by VASP (Vasodilator Stimulated Phosphoprotein Phosphorylation) Flow Cytometry and Expressed as %PRI (Platelet Reactivity Index)
STEMI at 240 mins
|
63.14 %PRI
Standard Deviation 13.26
|
57.00 %PRI
Standard Deviation 10.39
|
51.38 %PRI
Standard Deviation 14.06
|
—
|
|
Pharmacodynamic Assessment of Degree of Platelet Inhibition as Determined by VASP (Vasodilator Stimulated Phosphoprotein Phosphorylation) Flow Cytometry and Expressed as %PRI (Platelet Reactivity Index)
NSTEMI at 20 mins
|
75.17 %PRI
Standard Deviation 2.74
|
33.27 %PRI
Standard Deviation 10.66
|
62.00 %PRI
Standard Deviation 8.79
|
—
|
|
Pharmacodynamic Assessment of Degree of Platelet Inhibition as Determined by VASP (Vasodilator Stimulated Phosphoprotein Phosphorylation) Flow Cytometry and Expressed as %PRI (Platelet Reactivity Index)
NSTEMI at 60 mins
|
76.75 %PRI
Standard Deviation 4.35
|
21.91 %PRI
Standard Deviation 9.72
|
33.17 %PRI
Standard Deviation 17.73
|
—
|
|
Pharmacodynamic Assessment of Degree of Platelet Inhibition as Determined by VASP (Vasodilator Stimulated Phosphoprotein Phosphorylation) Flow Cytometry and Expressed as %PRI (Platelet Reactivity Index)
NSTEMI at 240 mins
|
61.83 %PRI
Standard Deviation 5.82
|
15.18 %PRI
Standard Deviation 5.85
|
20.17 %PRI
Standard Deviation 10.48
|
—
|
Adverse Events
Clopidogrel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Prasugrel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place