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P3AMI Antiplatelet Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02376283
Recruitment Status : Completed
First Posted : March 3, 2015
Results First Posted : September 18, 2019
Last Update Posted : February 10, 2020
Sponsor:
Information provided by (Responsible Party):
The Royal Wolverhampton Hospitals NHS Trust

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Heart Attack
Interventions Drug: Prasugrel
Drug: Clopidogrel
Drug: ticagrelor
Enrollment 87
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clopidogrel Prasugrel Ticagrelor
Hide Arm/Group Description

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.

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.

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.

Period Title: Overall Study
Started 27 30 30
Completed 27 30 30
Not Completed 0 0 0
Arm/Group Title Clopidogrel Prasugrel Ticagrelor Total
Hide Arm/Group Description

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 27 30 30 87
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 30 participants 30 participants 87 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
  33.3%
19
  63.3%
13
  43.3%
41
  47.1%
>=65 years
18
  66.7%
11
  36.7%
17
  56.7%
46
  52.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 30 participants 30 participants 87 participants
Female
8
  29.6%
5
  16.7%
6
  20.0%
19
  21.8%
Male
19
  70.4%
25
  83.3%
24
  80.0%
68
  78.2%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 27 participants 30 participants 30 participants 87 participants
27 30 30 87
1.Primary Outcome
Title Pharmacodynamic Assessment of Degree of Platelet Inhibition as Determined by Verify Now Point of Care Assay and Expressed as P2Y12 Reaction Units (PRU)
Hide Description [Not Specified]
Time Frame Balloon Inflation as Baseline, 20, 60, 240 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Clopidogrel Prasugrel Ticagrelor
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 27 30 30
Mean (Standard Deviation)
Unit of Measure: P2Y12 reaction units (PRU)
STEMI at 20 mins Number Analyzed 14 participants 15 participants 15 participants
270.23  (38.56) 247.73  (48.78) 256.73  (50.81)
STEMI at balloon inflation Number Analyzed 14 participants 15 participants 15 participants
286.46  (33.12) 253.73  (57.17) 257.93  (61.12)
STEMI at 60 mins Number Analyzed 14 participants 15 participants 15 participants
293.46  (31.68) 262.87  (43.43) 225.20  (82.70)
STEMI at 240 mins Number Analyzed 14 participants 15 participants 15 participants
226.42  (69.44) 128.64  (89.16) 176.27  (84.92)
NSTEMI at 20 mins Number Analyzed 13 participants 15 participants 15 participants
213.21  (51.74) 125.80  (89.34) 172.80  (92.54)
NSTEMI at 60 mins Number Analyzed 13 participants 15 participants 15 participants
227.36  (61.19) 76.93  (99.24) 114.20  (122.22)
NSTEMI at 240 mins Number Analyzed 13 participants 15 participants 15 participants
214.00  (69.98) 31.87  (45.52) 23.00  (18.94)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clopidogrel, Prasugrel, Ticagrelor
Comments Continuous variables expressed as mean ± SD (standard deviation) and categorical variables as frequencies (%).Continuous variables analysed individually using student's independent sample t-tests. Categorical variables assessed using separate Fisher's exact (Chi-square) test.
Type of Statistical Test Other
Comments A p value < 0.05 was considered to be statistically significant.Comparison of means between groups assessed using ANOVA allowing comparison of more than 2 means and enabled assessment made of the relationship between different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.
Statistical Test of Hypothesis P-Value <0.05
Comments Assessment made of relationship between groups-clop vs pras vs tic,rows of STEMI vs NSTEMI/UA and different time points.P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Clopidogrel, Prasugrel, Ticagrelor
Comments STEMI- clop vs prasl vs tic
Type of Statistical Test Other
Comments Comparison of means between groups assessed using ANOVA allowing comparison of more than 2 means and enabled assessment made of the relationship between different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANOVA
Comments ANOVA F(3,36) = 12.282
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Clopidogrel, Prasugrel, Ticagrelor
Comments NSTEMI- clopidogrel vs prasugrel vs ticagrelor
Type of Statistical Test Other
Comments Comparison of means between groups assessed using ANOVA allowing comparison of more than 2 means and enabled assessment made of the relationship between different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.
Statistical Test of Hypothesis P-Value < 0.0001
Comments Assessment made of relationship between groups-clop vs pras vs tic,rows of STEMI vs NSTEMI/UA and different time points.P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.
Method ANOVA
Comments ANOVA F(2,40) = 29.097
2.Primary Outcome
Title 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
Hide Description 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.
Time Frame Balloon Inflation as Baseline, 20, 60, 240 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Clopidogrel Prasugrel Ticagrelor Ticagrelor Parent Compound
Hide Arm/Group Description:

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.

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.

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.

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
Overall Number of Participants Analyzed 27 30 30 30
Mean (Standard Error)
Unit of Measure: ng/ml
STEMI at 20 mins Number Analyzed 14 participants 15 participants 15 participants 15 participants
39.12  (16.17) 14.27  (8.80) 0.16  (0.16) 9.04  (4.12)
STEMI at balloon inflation Number Analyzed 14 participants 15 participants 15 participants 15 participants
107.83  (44.08) 24.20  (13.07) 1.64  (1.17) 28.56  (12.58)
STEMI at 60 mins Number Analyzed 14 participants 15 participants 15 participants 15 participants
71.02  (27.21) 36.86  (13.27) 14.43  (7.28) 47.13  (24.09)
STEMI at 240 mins Number Analyzed 14 participants 15 participants 15 participants 15 participants
32.41  (6.71) 38.44  (7.59) 53.38  (25.21) 84.92  (42.00)
NSTEMI at 20 mins Number Analyzed 13 participants 15 participants 15 participants 15 participants
41.99  (25.27) 515.80  (126.84) 7.72  (5.10) 22.78  (10.27)
NSTEMI at 60 mins Number Analyzed 13 participants 15 participants 15 participants 15 participants
93.35  (49.65) 194.59  (29.97) 58.40  (25.41) 84.13  (34.02)
NSTEMI at 240 mins Number Analyzed 13 participants 15 participants 15 participants 15 participants
27.71  (6.90) 36.80  (4.59) 113.59  (19.20) 140.61  (36.31)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clopidogrel, Prasugrel, Ticagrelor, Ticagrelor Parent Compound
Comments

Continuous variables were expressed as mean ± SEM (Standard Error of Measurement) and categorical variables as frequencies (%).

Continuous variables were analysed individually using student's independent sample t-tests. Categorical variables were assessed using separate Fisher's exact (Chi-square) test.

Type of Statistical Test Other
Comments Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel active metabolite vs prasugrel active metabolite vs ticagrelor parent compound and active metabolite), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.
Statistical Test of Hypothesis P-Value <0.05
Comments Assessment made of relationship between groups-clop vs pras vs tic, rows of STEMI vs NSTEMI/UA and different time points. P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Clopidogrel, Prasugrel, Ticagrelor, Ticagrelor Parent Compound
Comments STEMI- different drugs (as stated above)
Type of Statistical Test Other
Comments Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel active metabolite vs prasugrel active metabolite vs ticagrelor parent compound and active metabolite), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.
Statistical Test of Hypothesis P-Value =0.123
Comments [Not Specified]
Method ANOVA
Comments ANOVA F(6,56)=1.707
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Clopidogrel, Prasugrel, Ticagrelor, Ticagrelor Parent Compound
Comments NSTEMI- different drugs (as stated above)
Type of Statistical Test Other
Comments Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel active metabolite vs prasugrel active metabolite vs ticagrelor parent compound and active metabolite), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.
Statistical Test of Hypothesis P-Value <0.0001
Comments Assessment made of relationship between groups-clop vs pras vs tic, rows of STEMI vs NSTEMI/UA and different time points. P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.
Method ANOVA
Comments ANOVA F(4,62)=18.932
3.Secondary Outcome
Title Pharmacodynamic Assessment of Degree of Platelet Inhibition as Determined by VASP (Vasodilator Stimulated Phosphoprotein Phosphorylation) Flow Cytometry and Expressed as %PRI (Platelet Reactivity Index)
Hide Description [Not Specified]
Time Frame Balloon Inflation as Baseline, 20, 60, 240 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Clopidogrel Prasugrel Ticagrelor
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 27 30 30
Mean (Standard Deviation)
Unit of Measure: %PRI
STEMI at 20 mins Number Analyzed 14 participants 15 participants 15 participants
76.29  (8.77) 46.25  (13.91) 79.75  (9.20)
STEMI at balloon inflation Number Analyzed 14 participants 15 participants 15 participants
74.86  (9.00) 41.13  (12.71) 74.63  (11.42)
STEMI at 60 mins Number Analyzed 14 participants 15 participants 15 participants
71.57  (11.68) 50.50  (11.88) 76.25  (11.12)
STEMI at 240 mins Number Analyzed 14 participants 15 participants 15 participants
63.14  (13.26) 57.00  (10.39) 51.38  (14.06)
NSTEMI at 20 mins Number Analyzed 13 participants 15 participants 15 participants
75.17  (2.74) 33.27  (10.66) 62.00  (8.79)
NSTEMI at 60 mins Number Analyzed 13 participants 15 participants 15 participants
76.75  (4.35) 21.91  (9.72) 33.17  (17.73)
NSTEMI at 240 mins Number Analyzed 13 participants 15 participants 15 participants
61.83  (5.82) 15.18  (5.85) 20.17  (10.48)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clopidogrel, Prasugrel, Ticagrelor
Comments

Continuous variables were expressed as mean ± SD and categorical variables as frequencies (%).

Continuous variables were analysed individually using student's independent sample t-tests. Categorical variables were assessed using separate Fisher's exact (Chi-square) test.

Type of Statistical Test Other
Comments Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA) and different time points.
Statistical Test of Hypothesis P-Value <0.05
Comments Assessment made of relationship between groups-clop vs pras vs tic, rows of STEMI vs NSTEMI/UA and different time points. P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Clopidogrel, Prasugrel, Ticagrelor
Comments

Continuous variables were expressed as mean ± SD and categorical variables as frequencies (%).

Continuous variables were analysed individually using student's independent sample t-tests. Categorical variables were assessed using separate Fisher's exact (Chi-square) test.

Type of Statistical Test Other
Comments Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA) and different time points.
Statistical Test of Hypothesis P-Value =0.810
Comments STEMI- clopidogrel vs prasugrel vs ticagrelor
Method ANOVA
Comments ANOVA F(3,17) = 0.321
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Clopidogrel, Ticagrelor
Comments

Continuous variables were expressed as mean ± SD and categorical variables as frequencies (%).

Continuous variables were analysed individually using student's independent sample t-tests. Categorical variables were assessed using separate Fisher's exact (Chi-square) test.

Type of Statistical Test Other
Comments Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA) and different time points.
Statistical Test of Hypothesis P-Value < 0.0001
Comments NSTEMI- clopi vs pras vs tic
Method ANOVA
Comments ANOVA F(2,25) = 14.103
Time Frame 4 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clopidogrel Prasugrel Ticagrelor
Hide Arm/Group Description

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.

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.

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.

All-Cause Mortality
Clopidogrel Prasugrel Ticagrelor
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/30 (0.00%)   0/30 (0.00%) 
Hide Serious Adverse Events
Clopidogrel Prasugrel Ticagrelor
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/30 (0.00%)   0/30 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Clopidogrel Prasugrel Ticagrelor
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/30 (0.00%)   0/30 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof James Cotton
Organization: The Royal Wolverhampton NHS Trust
Phone: 01902307999
EMail: jamescotton@nhs.net
Layout table for additonal information
Responsible Party: The Royal Wolverhampton Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02376283    
Other Study ID Numbers: 2012-004-04-02-CARD
First Submitted: February 2, 2015
First Posted: March 3, 2015
Results First Submitted: June 25, 2019
Results First Posted: September 18, 2019
Last Update Posted: February 10, 2020