Trial Outcomes & Findings for The Effect on Blood Cells, Known as Platelets, Using Prasugrel vs Clopidogrel in Patients With the Heart Problem Acute Coronary Syndrome (ACS) (NCT NCT00385944)
NCT ID: NCT00385944
Last Updated: 2010-09-16
Results Overview
Maximum platelet aggregation (MPA) to 20 μM adenosine diphosphate (ADP) was assessed by light transmission aggregometry (LTA).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
14 days after maintenance dose (MD)
Results posted on
2010-09-16
Participant Flow
A total of 56 patients received a clopidogrel loading dose (LD) of 900 mg and were then randomized to receive a maintenance dose (MD) of either 10-mg prasugrel or 150-mg clopidogrel. Two patients withdrew from the study after randomization but prior to receiving a MD, one due to subject decision and one due to physician decision.
Participant milestones
| Measure |
Prasugrel/Clopidogrel
One time oral loading dose (LD) of 900-mg clopidogrel (a single or cumulative dose)followed by a once daily MD of prasugrel 10 mg and 100 mg aspirin, for 14 days. Patients cross-over to a daily MD of clopidogrel 150 mg and 100 mg aspirin for an additional 14 days.
|
Clopidogrel/Prasugrel
One time oral loading dose (LD) of 900-mg clopidogrel (a single or cumulative dose)followed by a once daily MD of clopidogrel 150 mg and 100 mg aspirin, for 14 days. Patients cross-over to a daily MD of prasugrel 10 mg and 100 mg aspirin for an additional 14 days.
|
Loading Dose
Clopidogrel 900-mg Loading Dose (a single or cumulative dose)
|
|---|---|---|---|
|
Loading Dose
STARTED
|
0
|
0
|
56
|
|
Loading Dose
COMPLETED
|
0
|
0
|
56
|
|
Loading Dose
NOT COMPLETED
|
0
|
0
|
0
|
|
1st Maintenance Dose Period
STARTED
|
29
|
25
|
0
|
|
1st Maintenance Dose Period
COMPLETED
|
25
|
24
|
0
|
|
1st Maintenance Dose Period
NOT COMPLETED
|
4
|
1
|
0
|
|
2nd Maintenance Dose Period
STARTED
|
24
|
22
|
0
|
|
2nd Maintenance Dose Period
COMPLETED
|
22
|
19
|
0
|
|
2nd Maintenance Dose Period
NOT COMPLETED
|
2
|
3
|
0
|
Reasons for withdrawal
| Measure |
Prasugrel/Clopidogrel
One time oral loading dose (LD) of 900-mg clopidogrel (a single or cumulative dose)followed by a once daily MD of prasugrel 10 mg and 100 mg aspirin, for 14 days. Patients cross-over to a daily MD of clopidogrel 150 mg and 100 mg aspirin for an additional 14 days.
|
Clopidogrel/Prasugrel
One time oral loading dose (LD) of 900-mg clopidogrel (a single or cumulative dose)followed by a once daily MD of clopidogrel 150 mg and 100 mg aspirin, for 14 days. Patients cross-over to a daily MD of prasugrel 10 mg and 100 mg aspirin for an additional 14 days.
|
Loading Dose
Clopidogrel 900-mg Loading Dose (a single or cumulative dose)
|
|---|---|---|---|
|
1st Maintenance Dose Period
Physician Decision
|
1
|
0
|
0
|
|
1st Maintenance Dose Period
Entry Criteria Exclusion
|
0
|
1
|
0
|
|
1st Maintenance Dose Period
Invalid Pharmacodynamic Data
|
3
|
0
|
0
|
|
2nd Maintenance Dose Period
Invalid PD Data
|
2
|
3
|
0
|
Baseline Characteristics
The Effect on Blood Cells, Known as Platelets, Using Prasugrel vs Clopidogrel in Patients With the Heart Problem Acute Coronary Syndrome (ACS)
Baseline characteristics by cohort
| Measure |
Prasugrel/Clopidogrel
n=29 Participants
One time oral loading dose (LD) of 900-mg clopidogrel (a single or cumulative dose) followed by a once daily MD of prasugrel 10 mg and 100 mg aspirin, for 14 days. Patients cross-over to a daily MD of clopidogrel 150 mg and 100 mg aspirin for an additional 14 days.
|
Clopidogrel/Prasugrel
n=27 Participants
One time oral loading dose (LD) of 900-mg clopidogrel (a single or cumulative dose) followed by a once daily MD of clopidogrel 150 mg and 100 mg aspirin, for 14 days. Patients cross-over to a daily MD of prasugrel 10 mg and 100 mg aspirin for an additional 14 days.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
63 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
58 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
61 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
29 participants
n=5 Participants
|
27 participants
n=7 Participants
|
56 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 days after maintenance dose (MD)Population: The primary analysis was performed on the intent-to-treat (ITT) population, that is, all randomized subjects with a maintenance dose MPA measured for at least one of the treatments.
Maximum platelet aggregation (MPA) to 20 μM adenosine diphosphate (ADP) was assessed by light transmission aggregometry (LTA).
Outcome measures
| Measure |
Prasugrel
n=49 Participants
Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
|
Clopidogrel
n=47 Participants
Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
|
|---|---|---|
|
Maximum Platelet Aggregation (MPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP)
|
27.1 Percentage aggregation
Standard Deviation 10.55
|
40.3 Percentage aggregation
Standard Deviation 14.96
|
SECONDARY outcome
Timeframe: 14 days after maintenance dose (MD)Maximum platelet aggregation to 5 μM ADP was assessed by LTA.
Outcome measures
| Measure |
Prasugrel
n=49 Participants
Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
|
Clopidogrel
n=47 Participants
Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
|
|---|---|---|
|
MPA to 5 μM ADP
|
16.9 Percentage aggregation
Standard Deviation 8.3
|
25.0 Percentage aggregation
Standard Deviation 11.09
|
SECONDARY outcome
Timeframe: 14 days after maintenance dose (MD)Residual platelet aggregation is the percentage (%) aggregation value as measured by LTA at 6 minutes after the addition of ADP.
Outcome measures
| Measure |
Prasugrel
n=49 Participants
Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
|
Clopidogrel
n=47 Participants
Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
|
|---|---|---|
|
Mean Residual Platelet Aggregation (RPA) to 20 µM ADP
|
9.4 Percentage aggregation
Standard Deviation 11.43
|
21.6 Percentage aggregation
Standard Deviation 21.54
|
SECONDARY outcome
Timeframe: 14 days after maintenance dose (MD)Residual platelet aggregation is the percentage (%) aggregation value as measured by LTA at 6 minutes after the addition of ADP.
Outcome measures
| Measure |
Prasugrel
n=49 Participants
Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
|
Clopidogrel
n=47 Participants
Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
|
|---|---|---|
|
Mean Residual Platelet Aggregation (RPA) to 5 µM ADP
|
2.7 Percentage aggregation
Standard Deviation 5.26
|
7.1 Percentage aggregation
Standard Deviation 10.64
|
SECONDARY outcome
Timeframe: 14 days after maintenance dose (MD)Population: Note: This was calculated only for subjects with a true clopidogrel-free measure at baseline (Visit 1)
IPA is calculated as a percent decrease of MPA from baseline using the following formula: (\[MPA at baseline - MPA at time of postbaseline\] / MPA at baseline) x 100%
Outcome measures
| Measure |
Prasugrel
n=22 Participants
Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
|
Clopidogrel
n=21 Participants
Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
|
|---|---|---|
|
Inhibition Platelet Aggregation (IPA) to 20 μM ADP
|
64.2 Percentage inhibition
Standard Deviation 14.39
|
48.5 Percentage inhibition
Standard Deviation 18.58
|
SECONDARY outcome
Timeframe: 14 days after maintenance dose (MD)Population: Note: This was calculated only for subjects with a true clopidogrel-free measure at baseline (Visit 1)
IPA is calculated as a percent decrease of MPA from baseline using the following formula: (\[MPA at baseline - MPA at time of postbaseline\] / MPA at baseline) x 100%
Outcome measures
| Measure |
Prasugrel
n=22 Participants
Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
|
Clopidogrel
n=21 Participants
Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
|
|---|---|---|
|
Inhibition Platelet Aggregation (IPA) to 5 μM ADP
|
72.4 Percentage inhibition
Standard Deviation 12.76
|
58.8 Percentage inhibition
Standard Deviation 17.33
|
SECONDARY outcome
Timeframe: 14 days after maintenance dose (MD)Population: Note: This was calculated only for subjects with a true clopidogrel-free measure at baseline (Visit 1)
IRPA is calculated as a percent decrease of RPA from baseline using the following formula: (\[RPA at baseline - RPA at time of postbaseline\] / RPA at baseline) x 100%
Outcome measures
| Measure |
Prasugrel
n=23 Participants
Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
|
Clopidogrel
n=23 Participants
Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
|
|---|---|---|
|
Inhibition of Residual Platelet Aggregation (IRPA) to 20 μM ADP
|
87.1 Percentage inhibition
Standard Deviation 15.26
|
75.9 Percentage inhibition
Standard Deviation 25.99
|
SECONDARY outcome
Timeframe: 14 days after maintenance dose (MD)Population: Note: This was calculated only for subjects with a true clopidogrel-free measure at baseline (Visit 1)
IRPA is calculated as a percent decrease of RPA from baseline using the following formula: (\[RPA at baseline - RPA at time of postbaseline\] / RPA at baseline) x 100%
Outcome measures
| Measure |
Prasugrel
n=23 Participants
Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
|
Clopidogrel
n=23 Participants
Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
|
|---|---|---|
|
Inhibition of Residual Platelet Aggregation (IRPA) to 5 μM ADP
|
95.6 Percentage inhibition
Standard Deviation 6.5
|
91.4 Percentage inhibition
Standard Deviation 15.18
|
SECONDARY outcome
Timeframe: 14 days after maintenance dose (MD)Platelet Reactivity Index percentage was assessed by Vasodilator-stimulated phosphoprotein (VASP). PRI percent (%) was calculated using the median fluorescence intensity (MFI) of samples included with prostaglandin E1 (PGE1) and ADP, according to the following formula: PRI%=\[(MFI(PGE1)-MFI(PGE1 + ADP)/MFI(PGE1)\]x100 Lower PRI% values indicate greater P2Y12 receptor blockade.
Outcome measures
| Measure |
Prasugrel
n=49 Participants
Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
|
Clopidogrel
n=47 Participants
Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
|
|---|---|---|
|
Platelet Reactivity Index (PRI)
|
22.1 Percentage PRI
Standard Deviation 14.33
|
39.4 Percentage PRI
Standard Deviation 21.05
|
SECONDARY outcome
Timeframe: 14 days after maintenance dose (MD)P2Y12 Reaction Units (PRU) assessed by Accumetrics Verify NowTM P2Y12. PRU represents the rate and extent of adenosine (ADP)-stimulated platelet aggregation. Lower values indicate greater P2Y12 platelet inhibition.
Outcome measures
| Measure |
Prasugrel
n=47 Participants
Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
|
Clopidogrel
n=47 Participants
Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
|
|---|---|---|
|
P2Y12 Reaction Units (PRU)
|
44 PRU
Standard Deviation 38.59
|
98.7 PRU
Standard Deviation 63.69
|
SECONDARY outcome
Timeframe: 14 days after maintenance dose (MD)Poor responder is defined as MPA to 20 μM ADP \>75th percentile of the value at 6-18 hours post-clopidogrel LD.
Outcome measures
| Measure |
Prasugrel
n=49 Participants
Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
|
Clopidogrel
n=47 Participants
Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
|
|---|---|---|
|
Poor Responder of MPA to 20 μM ADP Following Maintenance Dose (MD)
Responder
|
48 Participants
|
35 Participants
|
|
Poor Responder of MPA to 20 μM ADP Following Maintenance Dose (MD)
Poor Responder
|
1 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Baseline to 6-18 hrs post loading dose (LD)Population: Note: This was calculated only for subjects with a true clopidogrel-free measure at baseline (Visit 1)
Maximum platelet aggregation to 20 μM ADP was assessed by LTA.
Outcome measures
| Measure |
Prasugrel
n=23 Participants
Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
|
Clopidogrel
Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
|
|---|---|---|
|
Change in MPA to 20 μM ADP From Baseline to 6-18 Hrs Post Loading Dose (LD)
|
-35.5 Percentage aggregation
Standard Deviation 17.5
|
—
|
SECONDARY outcome
Timeframe: 6-18 hrs post loading dose (LD) to 14 days after the first maintenance dose (MD)Maximum platelet aggregation to 20 μM ADP was assessed by LTA.
Outcome measures
| Measure |
Prasugrel
n=23 Participants
Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
|
Clopidogrel
n=20 Participants
Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
|
|---|---|---|
|
Change in MPA to 20 μM ADP From 6-18 Hrs Post Loading Dose (LD) to 14 Days After the First Maintenance Dose (MD)
|
-9 Percentage aggregation
Standard Deviation 15.71
|
-0.6 Percentage aggregation
Standard Deviation 12.56
|
SECONDARY outcome
Timeframe: 14 days after the first maintenance dose (MD)Population: Subjects providing evaluable MPA to 20 μM ADP at 14 days after the first maintenance dose (MD)
Maximum platelet aggregation to 20 μM ADP was assessed by LTA.
Outcome measures
| Measure |
Prasugrel
n=27 Participants
Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
|
Clopidogrel
n=24 Participants
Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
|
|---|---|---|
|
MPA to 20 μM ADP at 14 Days After the First Maintenance Dose (MD)
|
28.9 Percentage aggregation
Standard Deviation 11.14
|
38.2 Percentage aggregation
Standard Deviation 12.86
|
SECONDARY outcome
Timeframe: 14 days after the second maintenance dose (MD)Population: Subjects providing evaluable MPA to 20 μM ADP at Day 29.
Maximum platelet aggregation to 20 μM ADP was assessed by LTA.
Outcome measures
| Measure |
Prasugrel
n=23 Participants
Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
|
Clopidogrel
n=22 Participants
Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
|
|---|---|---|
|
MPA to 20 μM ADP at 14 Days After the Second Maintenance Dose (MD)
|
42.5 Percentage aggregation
Standard Deviation 16.89
|
25 Percentage aggregation
Standard Deviation 9.58
|
SECONDARY outcome
Timeframe: 14 days after maintenance dose (MD)Bleeding events will be classified as Major Bleeding, Minor Bleeding, or Insignificant Bleeding according to the TIMI criteria. Major bleeding: any intracranial hemorrhage (ICH) OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 gm/dL from baseline. Minor Bleeding: any clinically overt bleeding associated with a fall in Hgb of ≥3 grams/deciliter (gm/dL) but \<5 gm/dL from baseline. Insignificant bleeding: any bleeding event that does not meet criteria for a Major or Minor bleed.
Outcome measures
| Measure |
Prasugrel
n=51 Participants
Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
|
Clopidogrel
n=49 Participants
Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
|
|---|---|---|
|
Number of Participants With Bleeding Events According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria
Major
|
0 Participants
|
0 Participants
|
|
Number of Participants With Bleeding Events According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria
Minor
|
0 Participants
|
1 Participants
|
|
Number of Participants With Bleeding Events According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria
Insignificant
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 14 days after maintenance dose (MD)Bleeding events will be classified according to the GUSTO definitions as follows: Severe or Life-Threatening Bleeding: any ICH OR any bleeding event resulting in substantial hemodynamic compromise requiring treatment. Moderate Bleeding: any bleeding event resulting in the need for transfusion. Minor bleeding: any other bleeding event that does not require transfusion or cause hemodynamic compromise.
Outcome measures
| Measure |
Prasugrel
n=51 Participants
Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
|
Clopidogrel
n=49 Participants
Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
|
|---|---|---|
|
Number of Participants With Bleeding Events According to Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO)
Severe or life-threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants With Bleeding Events According to Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO)
Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Bleeding Events According to Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO)
Minor
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline through 29 days of treatmentPearson-correlation estimated between MPA to 20 μM ADP and Accumetrics VerifyNowTM P2Y12 PRU
Outcome measures
| Measure |
Prasugrel
n=56 Participants
Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
|
Clopidogrel
Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
|
|---|---|---|
|
Correlation of MPA to 20 μM ADP and PRU
|
0.8 Correlation coefficient
|
—
|
Adverse Events
Clopidogrel 900 mg LD
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Prasugrel 10 mg - 1st MD
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Clopidogrel 150 mg - 1st MD
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Clopidogrel 150 mg - Crossover From Prasugrel 10 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Prasugrel 10 mg - Crossover From Clopidogrel 150 mg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Clopidogrel 900 mg LD
n=56 participants at risk
One time oral loading dose (LD) of 900-mg clopidogrel
|
Prasugrel 10 mg - 1st MD
n=29 participants at risk
Once daily MD of prasugrel 10 mg and 100 mg aspirin, for 14 days.
|
Clopidogrel 150 mg - 1st MD
n=25 participants at risk
Once daily MD of clopidogrel 150 mg and 100 mg aspirin, for 14 days.
|
Clopidogrel 150 mg - Crossover From Prasugrel 10 mg
n=24 participants at risk
Once daily MD of clopidogrel 150 mg and 100 mg aspirin, for an additional 14 days. These are patients who received a daily MD of prasugrel 10 mg and 100 mg aspirin during the 1st MD period.
|
Prasugrel 10 mg - Crossover From Clopidogrel 150 mg
n=22 participants at risk
Once daily MD of prasugrel 10 mg and 100 mg aspirin, for an additional 14 days. These are patients who received a daily MD of clopidogrel 150 mg and 100 mg aspirin during the 1st MD period.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/56
|
3.4%
1/29 • Number of events 1
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/22
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/56
|
3.4%
1/29 • Number of events 1
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/22
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/56
|
3.4%
1/29 • Number of events 1
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/22
|
|
General disorders
Chest pain
|
0.00%
0/56
|
0.00%
0/29
|
0.00%
0/25
|
4.2%
1/24 • Number of events 1
|
0.00%
0/22
|
|
Infections and infestations
Septic shock
|
0.00%
0/56
|
3.4%
1/29 • Number of events 1
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/22
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/56
|
0.00%
0/29
|
0.00%
0/25
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
1.8%
1/56 • Number of events 1
|
0.00%
0/29
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/22
|
|
Nervous system disorders
Dizziness
|
0.00%
0/56
|
0.00%
0/29
|
0.00%
0/25
|
4.2%
1/24 • Number of events 2
|
0.00%
0/22
|
Other adverse events
| Measure |
Clopidogrel 900 mg LD
n=56 participants at risk
One time oral loading dose (LD) of 900-mg clopidogrel
|
Prasugrel 10 mg - 1st MD
n=29 participants at risk
Once daily MD of prasugrel 10 mg and 100 mg aspirin, for 14 days.
|
Clopidogrel 150 mg - 1st MD
n=25 participants at risk
Once daily MD of clopidogrel 150 mg and 100 mg aspirin, for 14 days.
|
Clopidogrel 150 mg - Crossover From Prasugrel 10 mg
n=24 participants at risk
Once daily MD of clopidogrel 150 mg and 100 mg aspirin, for an additional 14 days. These are patients who received a daily MD of prasugrel 10 mg and 100 mg aspirin during the 1st MD period.
|
Prasugrel 10 mg - Crossover From Clopidogrel 150 mg
n=22 participants at risk
Once daily MD of prasugrel 10 mg and 100 mg aspirin, for an additional 14 days. These are patients who received a daily MD of clopidogrel 150 mg and 100 mg aspirin during the 1st MD period.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/56
|
3.4%
1/29 • Number of events 1
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/22
|
|
Cardiac disorders
Bradycardia
|
3.6%
2/56 • Number of events 2
|
0.00%
0/29
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/22
|
|
Cardiac disorders
Cardiac flutter
|
0.00%
0/56
|
0.00%
0/29
|
4.0%
1/25 • Number of events 1
|
0.00%
0/24
|
0.00%
0/22
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/56
|
0.00%
0/29
|
4.0%
1/25 • Number of events 1
|
0.00%
0/24
|
0.00%
0/22
|
|
Cardiac disorders
Ventricular extrasystoles
|
1.8%
1/56 • Number of events 1
|
0.00%
0/29
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/22
|
|
Cardiac disorders
Ventricular tachycardia
|
5.4%
3/56 • Number of events 3
|
0.00%
0/29
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/22
|
|
Ear and labyrinth disorders
Vertigo
|
1.8%
1/56 • Number of events 1
|
0.00%
0/29
|
4.0%
1/25 • Number of events 1
|
0.00%
0/24
|
0.00%
0/22
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/56
|
0.00%
0/29
|
0.00%
0/25
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/56
|
3.4%
1/29 • Number of events 1
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/22
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/56
|
6.9%
2/29 • Number of events 2
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/22
|
|
Gastrointestinal disorders
Nausea
|
1.8%
1/56 • Number of events 1
|
0.00%
0/29
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/22
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/56
|
3.4%
1/29 • Number of events 1
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/22
|
|
General disorders
Asthenia
|
0.00%
0/56
|
6.9%
2/29 • Number of events 2
|
0.00%
0/25
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Chest pain
|
5.4%
3/56 • Number of events 3
|
3.4%
1/29 • Number of events 1
|
0.00%
0/25
|
4.2%
1/24 • Number of events 1
|
0.00%
0/22
|
|
General disorders
Malaise
|
1.8%
1/56 • Number of events 1
|
0.00%
0/29
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/22
|
|
General disorders
Pain
|
1.8%
1/56 • Number of events 1
|
0.00%
0/29
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/22
|
|
General disorders
Puncture site haemorrhage
|
1.8%
1/56 • Number of events 1
|
0.00%
0/29
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/22
|
|
General disorders
Pyrexia
|
0.00%
0/56
|
3.4%
1/29 • Number of events 1
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/22
|
|
Immune system disorders
Hypersensitivity
|
1.8%
1/56 • Number of events 1
|
0.00%
0/29
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/22
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/56
|
3.4%
1/29 • Number of events 1
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/22
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
1.8%
1/56 • Number of events 1
|
3.4%
1/29 • Number of events 1
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/22
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/56
|
3.4%
1/29 • Number of events 1
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/22
|
|
Investigations
Oxygen saturation decreased
|
1.8%
1/56 • Number of events 1
|
0.00%
0/29
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/22
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/56
|
3.4%
1/29 • Number of events 1
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/22
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.6%
2/56 • Number of events 2
|
0.00%
0/29
|
4.0%
1/25 • Number of events 1
|
0.00%
0/24
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/56
|
3.4%
1/29 • Number of events 1
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/56
|
3.4%
1/29 • Number of events 1
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.8%
1/56 • Number of events 1
|
3.4%
1/29 • Number of events 1
|
0.00%
0/25
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.8%
1/56 • Number of events 1
|
3.4%
1/29 • Number of events 1
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
1.8%
1/56 • Number of events 1
|
0.00%
0/29
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/22
|
|
Nervous system disorders
Dizziness
|
1.8%
1/56 • Number of events 1
|
0.00%
0/29
|
0.00%
0/25
|
4.2%
1/24 • Number of events 1
|
0.00%
0/22
|
|
Nervous system disorders
Headache
|
8.9%
5/56 • Number of events 5
|
0.00%
0/29
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/22
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/56
|
0.00%
0/29
|
0.00%
0/25
|
4.2%
1/24 • Number of events 1
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/56
|
0.00%
0/29
|
4.0%
1/25 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/56
|
0.00%
0/29
|
4.0%
1/25 • Number of events 1
|
0.00%
0/24
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/56
|
3.4%
1/29 • Number of events 1
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
8.9%
5/56 • Number of events 5
|
3.4%
1/29 • Number of events 1
|
8.0%
2/25 • Number of events 2
|
0.00%
0/24
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
1.8%
1/56 • Number of events 1
|
0.00%
0/29
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/56
|
3.4%
1/29 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
0.00%
0/24
|
0.00%
0/22
|
|
Surgical and medical procedures
Cardioversion
|
0.00%
0/56
|
0.00%
0/29
|
0.00%
0/25
|
4.2%
1/24 • Number of events 1
|
0.00%
0/22
|
|
Vascular disorders
Flushing
|
0.00%
0/56
|
0.00%
0/29
|
4.0%
1/25 • Number of events 1
|
0.00%
0/24
|
0.00%
0/22
|
|
Vascular disorders
Hypertension
|
5.4%
3/56 • Number of events 3
|
0.00%
0/29
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/22
|
|
Vascular disorders
Hypotension
|
1.8%
1/56 • Number of events 1
|
3.4%
1/29 • Number of events 1
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/22
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60