Trial Outcomes & Findings for The Influence of Smoking Status on Prasugrel and Clopidogrel Treated Subjects Taking Aspirin and Having Stable Coronary Artery Disease (NCT NCT01260584)
NCT ID: NCT01260584
Last Updated: 2019-01-09
Results Overview
IPA will be measured by the Accumetrics P2Y12 Assay Device. Response will be assessed in P2Y12 Reaction Units and as Platelet Reactivity Index (vasodilator-stimulated phosphoprotein assay).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
110 participants
Primary outcome timeframe
Baseline to day 10 for Active Treatment Periods 1 and 2
Results posted on
2019-01-09
Participant Flow
Phase 4, double-blind, double-dummy, randomized, crossover study of male and female subjects with stable CAD, who are currently receiving aspirin and do not have contraindications for a thienopyridine.
Subjects will be stratified according to smoking status prior to being randomized to 1 of the 2 treatment sequences: prasugrel followed by clopidogrel or clopidogrel followed by prasugrel. There will be a 14-day Washout Period between Active Treatment Periods 1 and 2. All subjects will remain on the same dose of aspirin throughout the study.
Participant milestones
| Measure |
Clopidogrel Then Prasugrel Smokers
Clopidogrel 75 mg film-coated tablet daily dose x 10 days To maintain blinding, placebo film-coated tablets matching prasugrel in appearance will be given daily × 10 days to subjects in the clopidogrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.
Prasugrel : One 10 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken.
|
Clopidogrel Then Prasugrel Non-Smokers
Clopidogrel 75 mg film-coated tablet daily dose x 10 days To maintain blinding, placebo film-coated tablets matching prasugrel in appearance will be given daily × 10 days to subjects in the clopidogrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.
Prasugrel : One 10 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken.
|
Prasugrel Then Clopidogrel Smokers
Prasugrel 10 mg film-coated tablet daily dose × 10 days. To maintain blinding, placebo film-coated tablets matching clopidogrel in appearance will be given daily × 10 days to subjects in the prasugrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.
Clopidogrel : One 75 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken.
|
Prasugrel Then Clopidogrel Non-Smokers
Prasugrel 10 mg film-coated tablet daily dose × 10 days. To maintain blinding, placebo film-coated tablets matching clopidogrel in appearance will be given daily × 10 days to subjects in the prasugrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.
Clopidogrel : One 75 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken.
|
|---|---|---|---|---|
|
Period 1
STARTED
|
27
|
28
|
27
|
28
|
|
Period 1
COMPLETED
|
27
|
28
|
25
|
27
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
2
|
1
|
|
Period 2
STARTED
|
27
|
28
|
25
|
27
|
|
Period 2
COMPLETED
|
26
|
25
|
20
|
26
|
|
Period 2
NOT COMPLETED
|
1
|
3
|
5
|
1
|
Reasons for withdrawal
| Measure |
Clopidogrel Then Prasugrel Smokers
Clopidogrel 75 mg film-coated tablet daily dose x 10 days To maintain blinding, placebo film-coated tablets matching prasugrel in appearance will be given daily × 10 days to subjects in the clopidogrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.
Prasugrel : One 10 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken.
|
Clopidogrel Then Prasugrel Non-Smokers
Clopidogrel 75 mg film-coated tablet daily dose x 10 days To maintain blinding, placebo film-coated tablets matching prasugrel in appearance will be given daily × 10 days to subjects in the clopidogrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.
Prasugrel : One 10 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken.
|
Prasugrel Then Clopidogrel Smokers
Prasugrel 10 mg film-coated tablet daily dose × 10 days. To maintain blinding, placebo film-coated tablets matching clopidogrel in appearance will be given daily × 10 days to subjects in the prasugrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.
Clopidogrel : One 75 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken.
|
Prasugrel Then Clopidogrel Non-Smokers
Prasugrel 10 mg film-coated tablet daily dose × 10 days. To maintain blinding, placebo film-coated tablets matching clopidogrel in appearance will be given daily × 10 days to subjects in the prasugrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.
Clopidogrel : One 75 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken.
|
|---|---|---|---|---|
|
Period 1
Protocol Violation
|
0
|
0
|
1
|
1
|
|
Period 1
Adverse Event
|
0
|
0
|
1
|
0
|
|
Period 2
Protocol Violation
|
0
|
2
|
3
|
1
|
|
Period 2
Adverse Event
|
1
|
0
|
2
|
0
|
|
Period 2
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
Baseline Characteristics
The Influence of Smoking Status on Prasugrel and Clopidogrel Treated Subjects Taking Aspirin and Having Stable Coronary Artery Disease
Baseline characteristics by cohort
| Measure |
Clopidogrel Then Prasugrel Smokers
n=27 Participants
Clopidogrel 75 mg film-coated tablet daily dose x 10 days To maintain blinding, placebo film-coated tablets matching prasugrel in appearance will be given daily × 10 days to subjects in the clopidogrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.
Prasugrel : One 10 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken.
|
Clopidogrel Then Prasugrel Non-Smokers
n=28 Participants
Clopidogrel 75 mg film-coated tablet daily dose x 10 days To maintain blinding, placebo film-coated tablets matching prasugrel in appearance will be given daily × 10 days to subjects in the clopidogrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.
Prasugrel : One 10 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken.
|
Prasugrel Then Clopidogrel Smokers
n=27 Participants
Prasugrel 10 mg film-coated tablet daily dose × 10 days. To maintain blinding, placebo film-coated tablets matching clopidogrel in appearance will be given daily × 10 days to subjects in the prasugrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.
Clopidogrel : One 75 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken.
|
Prasugrel Then Clopidogrel Non-Smokers
n=28 Participants
Prasugrel 10 mg film-coated tablet daily dose × 10 days. To maintain blinding, placebo film-coated tablets matching clopidogrel in appearance will be given daily × 10 days to subjects in the prasugrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.
Clopidogrel : One 75 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
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
|
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
79 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Age, Continuous
|
59.3 years
STANDARD_DEVIATION 8.19 • n=5 Participants
|
59.6 years
STANDARD_DEVIATION 8.60 • n=7 Participants
|
56.7 years
STANDARD_DEVIATION 8.03 • n=5 Participants
|
61.9 years
STANDARD_DEVIATION 7.86 • n=4 Participants
|
59.4 years
STANDARD_DEVIATION 8.27 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
79 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
94 Participants
n=21 Participants
|
|
Ethnicity (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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 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
|
|
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
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
85 Participants
n=21 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
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
28 participants
n=7 Participants
|
27 participants
n=5 Participants
|
28 participants
n=4 Participants
|
110 participants
n=21 Participants
|
|
Weight
|
87.04 kg
STANDARD_DEVIATION 15.243 • n=5 Participants
|
92.45 kg
STANDARD_DEVIATION 18.433 • n=7 Participants
|
91.74 kg
STANDARD_DEVIATION 20.109 • n=5 Participants
|
99.91 kg
STANDARD_DEVIATION 23.096 • n=4 Participants
|
92.85 kg
STANDARD_DEVIATION 19.740 • n=21 Participants
|
|
Height
|
172.3 cm
STANDARD_DEVIATION 8.15 • n=5 Participants
|
172.5 cm
STANDARD_DEVIATION 10.95 • n=7 Participants
|
172.5 cm
STANDARD_DEVIATION 10.72 • n=5 Participants
|
173.7 cm
STANDARD_DEVIATION 8.17 • n=4 Participants
|
172.8 cm
STANDARD_DEVIATION 9.48 • n=21 Participants
|
|
Body Mass Index
|
29.20 kg/m^2
STANDARD_DEVIATION 3.945 • n=5 Participants
|
31.12 kg/m^2
STANDARD_DEVIATION 5.821 • n=7 Participants
|
30.70 kg/m^2
STANDARD_DEVIATION 5.131 • n=5 Participants
|
32.94 kg/m^2
STANDARD_DEVIATION 6.592 • n=4 Participants
|
31.01 kg/m^2
STANDARD_DEVIATION 5.562 • n=21 Participants
|
|
Body Mass Index Group
<30 kg/m^2
|
19 participants
n=5 Participants
|
10 participants
n=7 Participants
|
13 participants
n=5 Participants
|
10 participants
n=4 Participants
|
52 participants
n=21 Participants
|
|
Body Mass Index Group
>=30 kg/m^2
|
8 participants
n=5 Participants
|
18 participants
n=7 Participants
|
14 participants
n=5 Participants
|
18 participants
n=4 Participants
|
58 participants
n=21 Participants
|
|
Smoking History
Never Smoked
|
0 participants
n=5 Participants
|
14 participants
n=7 Participants
|
0 participants
n=5 Participants
|
11 participants
n=4 Participants
|
25 participants
n=21 Participants
|
|
Smoking History
Currently Smoke
|
27 participants
n=5 Participants
|
0 participants
n=7 Participants
|
27 participants
n=5 Participants
|
0 participants
n=4 Participants
|
54 participants
n=21 Participants
|
|
Smoking History
Formerly Smoked
|
0 participants
n=5 Participants
|
14 participants
n=7 Participants
|
0 participants
n=5 Participants
|
17 participants
n=4 Participants
|
31 participants
n=21 Participants
|
|
Alcohol Usage
Never consumed
|
6 participants
n=5 Participants
|
9 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
31 participants
n=21 Participants
|
|
Alcohol Usage
Currently consumes
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
13 participants
n=5 Participants
|
15 participants
n=4 Participants
|
61 participants
n=21 Participants
|
|
Alcohol Usage
Formerly consumed
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
5 participants
n=4 Participants
|
18 participants
n=21 Participants
|
|
Cardiovascular history
Diabetes mellitus
|
5 participants
n=5 Participants
|
9 participants
n=7 Participants
|
8 participants
n=5 Participants
|
9 participants
n=4 Participants
|
31 participants
n=21 Participants
|
|
Cardiovascular history
Hypertension
|
19 participants
n=5 Participants
|
16 participants
n=7 Participants
|
21 participants
n=5 Participants
|
20 participants
n=4 Participants
|
76 participants
n=21 Participants
|
|
Cardiovascular history
Hyperlipidemia
|
26 participants
n=5 Participants
|
24 participants
n=7 Participants
|
26 participants
n=5 Participants
|
27 participants
n=4 Participants
|
103 participants
n=21 Participants
|
|
Cardiovascular history
Peripheral artery disease
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
5 participants
n=5 Participants
|
2 participants
n=4 Participants
|
10 participants
n=21 Participants
|
|
CYP2C19 Phenotype Metabolic Rate
Poor
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
CYP2C19 Phenotype Metabolic Rate
Intermediate
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
4 participants
n=4 Participants
|
19 participants
n=21 Participants
|
|
CYP2C19 Phenotype Metabolic Rate
Extensive
|
18 participants
n=5 Participants
|
23 participants
n=7 Participants
|
20 participants
n=5 Participants
|
22 participants
n=4 Participants
|
83 participants
n=21 Participants
|
|
CYP2C19 Phenotype Metabolic Rate
Ultrarapid
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
CYP2C19 Phenotype Metabolic Rate
not reported
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
CYP2C19 Phenotype Metabolic Extent
Extensive metabolizers
|
21 participants
n=5 Participants
|
24 participants
n=7 Participants
|
21 participants
n=5 Participants
|
22 participants
n=4 Participants
|
88 participants
n=21 Participants
|
|
CYP2C19 Phenotype Metabolic Extent
Reduced metabolizers
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
21 participants
n=21 Participants
|
|
CYP2C19 Phenotype Metabolic Extent
Missing
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to day 10 for Active Treatment Periods 1 and 2Population: 1 prasugrel smoker was unevaluable for this measure.
IPA will be measured by the Accumetrics P2Y12 Assay Device. Response will be assessed in P2Y12 Reaction Units and as Platelet Reactivity Index (vasodilator-stimulated phosphoprotein assay).
Outcome measures
| Measure |
Prasugrel Smokers
n=50 Participants
participants who currently smoke while receiving prasugrel as test medication during study
|
Prasugrel Non-Smokers
n=52 Participants
participants who do not currently smoke while receiving prasugrel as test medication during study
|
Clopidogrel Smokers
n=47 Participants
participants who currently smoke while receiving clopidogrel as test medication during study
|
Clopidogrel Non-Smokers
n=54 Participants
participants who do not currently smoke while receiving clopidogrel as test medication during study
|
|---|---|---|---|---|
|
Inhibition of Platelet Aggregation (IPA) in Prasugrel-treated and Clopidogrel-treated Smokers and Non-smokers Following 9 Days of Maintenance Therapy.
|
70.3 percentage of device derived inhibition
Standard Error 2.91
|
65.6 percentage of device derived inhibition
Standard Error 2.86
|
38.6 percentage of device derived inhibition
Standard Error 3.01
|
30.9 percentage of device derived inhibition
Standard Error 2.81
|
SECONDARY outcome
Timeframe: Day 10 for Active Treatment Periods 1 and 2Population: 1 prasugrel smoker was unevaluable for this measure.
Day 10 occurs in each treatment period at which time data collections are made. 12.1.4. Responders and Poor Responders Numerous studies have established an association between high on-treatment platelet reactivity with clopidogrel and an increased risk for post-PCI ischemic events. In this study, the percentages of "responders" and "poor responders" following treatment with prasugrel and clopidogrel were compared. Poor responders were defined based on an Accumetrics VerifyNow PRU \>235 and a VASP PRI \>50%, as assessed 24 hours after the 9th maintenance dose.
Outcome measures
| Measure |
Prasugrel Smokers
n=50 Participants
participants who currently smoke while receiving prasugrel as test medication during study
|
Prasugrel Non-Smokers
n=52 Participants
participants who do not currently smoke while receiving prasugrel as test medication during study
|
Clopidogrel Smokers
n=47 Participants
participants who currently smoke while receiving clopidogrel as test medication during study
|
Clopidogrel Non-Smokers
n=54 Participants
participants who do not currently smoke while receiving clopidogrel as test medication during study
|
|---|---|---|---|---|
|
Assessment of P2Y12 Reaction Units (PRU) by Treatment and Smoking Status
|
85.1 P2Y12 reaction unit
Standard Error 8.99
|
106.3 P2Y12 reaction unit
Standard Error 8.73
|
178.9 P2Y12 reaction unit
Standard Error 9.26
|
215.1 P2Y12 reaction unit
Standard Error 8.59
|
SECONDARY outcome
Timeframe: Day 10 for Active Treatment Periods 1 and 2Population: 1 prasugrel smoker was unevaluable for this measure.
Day 10 occurs in each treatment period at which time data collections are made. Numerous studies have established an association between high on-treatment platelet reactivity with clopidogrel and an increased risk for post-PCI ischemic events. In this study, the percentages of "responders" and "poor responders" following treatment with prasugrel and clopidogrel were compared. Poor responders were defined based on an Accumetrics VerifyNow PRU \>235 and a VASP PRI \>50%, as assessed 24 hours after the 9th maintenance dose.
Outcome measures
| Measure |
Prasugrel Smokers
n=50 Participants
participants who currently smoke while receiving prasugrel as test medication during study
|
Prasugrel Non-Smokers
n=52 Participants
participants who do not currently smoke while receiving prasugrel as test medication during study
|
Clopidogrel Smokers
n=47 Participants
participants who currently smoke while receiving clopidogrel as test medication during study
|
Clopidogrel Non-Smokers
n=54 Participants
participants who do not currently smoke while receiving clopidogrel as test medication during study
|
|---|---|---|---|---|
|
Assessment of Vasodilator Stimulated Phosphoprotein (VASP) by Treatment and Smoking Status
|
25.4 % vasodilator stimulated phosphoprotein
Standard Error 2.64
|
31.2 % vasodilator stimulated phosphoprotein
Standard Error 2.59
|
48.1 % vasodilator stimulated phosphoprotein
Standard Error 2.73
|
55.7 % vasodilator stimulated phosphoprotein
Standard Error 2.54
|
SECONDARY outcome
Timeframe: Day 10 for Active Treatment Periods 1 and 2Population: 1 prasugrel smoker participant was not evaluable for this measure.
Outcome measures
| Measure |
Prasugrel Smokers
n=50 Participants
participants who currently smoke while receiving prasugrel as test medication during study
|
Prasugrel Non-Smokers
n=52 Participants
participants who do not currently smoke while receiving prasugrel as test medication during study
|
Clopidogrel Smokers
n=47 Participants
participants who currently smoke while receiving clopidogrel as test medication during study
|
Clopidogrel Non-Smokers
n=54 Participants
participants who do not currently smoke while receiving clopidogrel as test medication during study
|
|---|---|---|---|---|
|
Responder Rate by Treatment and Smoking Status Based on P2Y12 Reaction Units (PRU) <= 235
|
98.0 % participants with PRU <=235
|
96.2 % participants with PRU <=235
|
76.6 % participants with PRU <=235
|
61.1 % participants with PRU <=235
|
SECONDARY outcome
Timeframe: Day 10 for Active Treatment Periods 1 and 2Population: 1 prasugrel smoker participant was not evaluable for this measure.
Numerous studies have established an association between high on-treatment platelet reactivity with clopidogrel and an increased risk for post-PCI ischemic events. In this study, the percentages of "responders" and "poor responders" following treatment with prasugrel and clopidogrel were compared. Poor responders were defined based on an Accumetrics VerifyNow PRU \>235 and a VASP PRI \>50%, as assessed 24 hours after the 9th maintenance dose.
Outcome measures
| Measure |
Prasugrel Smokers
n=50 Participants
participants who currently smoke while receiving prasugrel as test medication during study
|
Prasugrel Non-Smokers
n=52 Participants
participants who do not currently smoke while receiving prasugrel as test medication during study
|
Clopidogrel Smokers
n=47 Participants
participants who currently smoke while receiving clopidogrel as test medication during study
|
Clopidogrel Non-Smokers
n=54 Participants
participants who do not currently smoke while receiving clopidogrel as test medication during study
|
|---|---|---|---|---|
|
Responder Rate by Treatment and Smoking Status Based on Platelet Reactivity Index (PRI) <= 50%
|
96.0 % participants with PRI <=50%
|
82.7 % participants with PRI <=50%
|
51.1 % participants with PRI <=50%
|
44.4 % participants with PRI <=50%
|
SECONDARY outcome
Timeframe: After dose on Day 10 of Active Treatment Periods 1 and 2Population: 1 Clopidogrel smoker participant was not evaluable for this measure.
Blood samples for determination of plasma concentrations of the prasugrel active metabolite, clopidogrel active metabolite, and clopidogrel inactive metabolite will be collected following the administration of the 10th (last) maintenance dose of each of the 2 Active Treatment Periods at 0.5, 1, 2, 4, and 6 hours post-dose.
Outcome measures
| Measure |
Prasugrel Smokers
n=51 Participants
participants who currently smoke while receiving prasugrel as test medication during study
|
Prasugrel Non-Smokers
n=52 Participants
participants who do not currently smoke while receiving prasugrel as test medication during study
|
Clopidogrel Smokers
n=46 Participants
participants who currently smoke while receiving clopidogrel as test medication during study
|
Clopidogrel Non-Smokers
n=54 Participants
participants who do not currently smoke while receiving clopidogrel as test medication during study
|
|---|---|---|---|---|
|
Characterization of the Pharmacokinetics (PK) Area Under Curve (AUC)(0-Last) of the Active Metabolite of Prasugrel and the Active Metabolite of Clopidogrel in Smokers and Non-smokers
|
53.7 hr*ng/mL
Geometric Coefficient of Variation 41.2
|
48.1 hr*ng/mL
Geometric Coefficient of Variation 52.0
|
19.9 hr*ng/mL
Geometric Coefficient of Variation 55.8
|
16.2 hr*ng/mL
Geometric Coefficient of Variation 87.4
|
SECONDARY outcome
Timeframe: After dose on Day 10 of Active Treatment Periods 1 and 2Population: 1 clopidogrel smoker was not evaluable for this measure.
Outcome measures
| Measure |
Prasugrel Smokers
n=51 Participants
participants who currently smoke while receiving prasugrel as test medication during study
|
Prasugrel Non-Smokers
n=52 Participants
participants who do not currently smoke while receiving prasugrel as test medication during study
|
Clopidogrel Smokers
n=46 Participants
participants who currently smoke while receiving clopidogrel as test medication during study
|
Clopidogrel Non-Smokers
n=54 Participants
participants who do not currently smoke while receiving clopidogrel as test medication during study
|
|---|---|---|---|---|
|
Characterization of the Pharmacokinetics (PK) Cmax of the Active Metabolite of Prasugrel and the Active Metabolite of Clopidogrel in Smokers and Non-smokers
|
42.9 ng/mL
Geometric Coefficient of Variation 66.1
|
35.9 ng/mL
Geometric Coefficient of Variation 80.7
|
14.1 ng/mL
Geometric Coefficient of Variation 84.3
|
10.8 ng/mL
Geometric Coefficient of Variation 116.3
|
Adverse Events
Prasugrel Smokers
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
Prasugrel Non-Smokers
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Clopidogrel Smokers
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Clopidogrel Non-Smokers
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prasugrel Smokers
n=54 participants at risk
participants who currently smoke while receiving prasugrel as test medication during study
|
Prasugrel Non-Smokers
n=55 participants at risk
participants who do not currently smoke while receiving prasugrel as test medication during study. 1 participant who started the arm was not "at risk".
|
Clopidogrel Smokers
n=50 participants at risk
participants who currently smoke while receiving clopidogrel as test medication during study. 2 participants who started this arm were not "At risk".
|
Clopidogrel Non-Smokers
n=54 participants at risk
participants who do not currently smoke while receiving clopidogrel as test medication during study. 1 participant who started this arm was not "at risk".
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Tendon rupture
|
1.9%
1/54 • Number of events 1
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/55
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/50
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
|
Infections and infestations
Cellulitis
|
1.9%
1/54 • Number of events 1
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/55
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/50
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
|
Infections and infestations
Osteomyelitis
|
1.9%
1/54 • Number of events 1
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/55
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/50
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
|
Infections and infestations
Staphylococcal infection
|
1.9%
1/54 • Number of events 1
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/55
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/50
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
|
Cardiac disorders
Acute coronary syndrome
|
1.9%
1/54 • Number of events 1
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/55
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/50
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
|
Infections and infestations
Hepatitis B
|
1.9%
1/54 • Number of events 1
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/55
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/50
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
Other adverse events
| Measure |
Prasugrel Smokers
n=54 participants at risk
participants who currently smoke while receiving prasugrel as test medication during study
|
Prasugrel Non-Smokers
n=55 participants at risk
participants who do not currently smoke while receiving prasugrel as test medication during study. 1 participant who started the arm was not "at risk".
|
Clopidogrel Smokers
n=50 participants at risk
participants who currently smoke while receiving clopidogrel as test medication during study. 2 participants who started this arm were not "At risk".
|
Clopidogrel Non-Smokers
n=54 participants at risk
participants who do not currently smoke while receiving clopidogrel as test medication during study. 1 participant who started this arm was not "at risk".
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/55
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
2.0%
1/50 • Number of events 1
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/55
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
2.0%
1/50 • Number of events 1
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/55
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
2.0%
1/50 • Number of events 1
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.9%
1/54 • Number of events 1
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/55
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
2.0%
1/50 • Number of events 1
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/55
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
2.0%
1/50 • Number of events 1
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
|
Psychiatric disorders
Abnormal Dreams
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/55
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
2.0%
1/50 • Number of events 1
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/55
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
2.0%
1/50 • Number of events 1
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/55
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
2.0%
1/50 • Number of events 1
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/55
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
2.0%
1/50 • Number of events 1
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
|
Nervous system disorders
Lethargy
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/55
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
2.0%
1/50 • Number of events 1
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Congestion
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/55
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
2.0%
1/50 • Number of events 1
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
|
General disorders
Vessel puncture site hemorrhage
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/55
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
2.0%
1/50 • Number of events 1
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
1.9%
1/54 • Number of events 1
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/55
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
2.0%
1/50 • Number of events 1
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
3.7%
2/54 • Number of events 2
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
|
Infections and infestations
Sinusitis
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
3.6%
2/55 • Number of events 2
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/50
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
1.9%
1/54 • Number of events 1
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
|
Infections and infestations
Upper respiratory tract infection
|
1.9%
1/54 • Number of events 1
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
3.6%
2/55 • Number of events 2
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/50
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
1.8%
1/55 • Number of events 1
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
4.0%
2/50 • Number of events 2
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
1.9%
1/54 • Number of events 1
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
3.7%
2/54 • Number of events 2
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
1.8%
1/55 • Number of events 1
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/50
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
|
Skin and subcutaneous tissue disorders
Increased tendency to bruise
|
1.9%
1/54 • Number of events 1
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
3.6%
2/55 • Number of events 2
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/50
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
|
General disorders
Fatigue
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/55
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
2.0%
1/50 • Number of events 1
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
1.9%
1/54 • Number of events 1
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/55
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
2.0%
1/50 • Number of events 1
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
0.00%
0/54
1 prasugrel non-smoker, 2 clopidogrel smokers, 1 clopidogrel non-smoker did not receive treatment in one period and were not determined to be "at-risk".
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reflects the following restrictive language in the Clinical Study Agreements: "If Daiichi Sankyo Inc. (DSI) identifies any of its confidential information as defined herein, it shall be deleted … Nothing in this publication section shall be taken as giving DSI any right of editorial control over any publication prepared by the Study Site."
- Publication restrictions are in place
Restriction type: OTHER