Trial Outcomes & Findings for Trial in Subjects Undergoing Cardiac Catheterization With Planned Percutaneous Coronary Intervention With Stenting (NCT NCT00357968)
NCT ID: NCT00357968
Last Updated: 2010-08-31
Results Overview
IPA was defined as (1 - \[maximal platelet aggregation(MPA) at 6 hours after study drug treatment\]/\[MPA before drug treatment\]) x 100.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
201 participants
Primary outcome timeframe
6 hours after loading dose
Results posted on
2010-08-31
Participant Flow
Participant milestones
| Measure |
Prasugrel to Clopidogrel
One time oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a once daily 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for 14 days (Treatment 1 Phase). Patients cross-over to a once daily 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally for the next 14 days (Treatment 2 Phase).
|
Clopidogrel to Prasugrel
One time oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a once daily 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally for 14 days (Treatment 1 Phase). Patients cross-over to a once daily 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for the next 14 days (Treatment 2 Phase).
|
|---|---|---|
|
First Maintenance Dose Phase
Received Loading Dose
|
102
|
99
|
|
First Maintenance Dose Phase
Percutaneous Coronary Intervention (PCI)
|
55
|
57
|
|
First Maintenance Dose Phase
Started Maintenance Dose
|
55
|
55
|
|
First Maintenance Dose Phase
STARTED
|
102
|
99
|
|
First Maintenance Dose Phase
COMPLETED
|
54
|
55
|
|
First Maintenance Dose Phase
NOT COMPLETED
|
48
|
44
|
|
Crossover Maintenance Dose Phase
STARTED
|
54
|
55
|
|
Crossover Maintenance Dose Phase
COMPLETED
|
54
|
55
|
|
Crossover Maintenance Dose Phase
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Prasugrel to Clopidogrel
One time oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a once daily 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for 14 days (Treatment 1 Phase). Patients cross-over to a once daily 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally for the next 14 days (Treatment 2 Phase).
|
Clopidogrel to Prasugrel
One time oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a once daily 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally for 14 days (Treatment 1 Phase). Patients cross-over to a once daily 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for the next 14 days (Treatment 2 Phase).
|
|---|---|---|
|
First Maintenance Dose Phase
Not a PCI patient
|
47
|
42
|
|
First Maintenance Dose Phase
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Trial in Subjects Undergoing Cardiac Catheterization With Planned Percutaneous Coronary Intervention With Stenting
Baseline characteristics by cohort
| Measure |
Prasugrel to Clopidogrel
n=102 Participants
One time oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a once daily 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for 14 days. Patients cross-over to a once daily 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally for the next 14 days.
|
Clopidogrel to Prasugrel
n=99 Participants
One time oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a once daily 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) for 14 days. Patients cross-over to a once daily 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for the next 14 days.
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
56 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Age Continuous
|
64.0 years
STANDARD_DEVIATION 10.73 • n=5 Participants
|
63.8 years
STANDARD_DEVIATION 9.38 • n=7 Participants
|
63.9 years
STANDARD_DEVIATION 10.06 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
97 participants
n=5 Participants
|
94 participants
n=7 Participants
|
191 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
West Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
France
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
55 participants
n=5 Participants
|
53 participants
n=7 Participants
|
108 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
15 participants
n=5 Participants
|
13 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
30 participants
n=7 Participants
|
59 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 hours after loading dosePopulation: Consists of all patients who received a loading dose of the study drug, did not receive a glycoprotein (GP) IIb/IIIa antagonist, and had evaluable pre-treatment and 6 hour MPA measurements. Patients had received a single loading dose of either 60-mg prasugrel or 600-mg clopidogrel but had not yet received any maintenance dosing.
IPA was defined as (1 - \[maximal platelet aggregation(MPA) at 6 hours after study drug treatment\]/\[MPA before drug treatment\]) x 100.
Outcome measures
| Measure |
Prasugrel
n=72 Participants
Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
|
Clopidogrel
n=77 Participants
Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to the administration of any maintenance dose.
|
|---|---|---|
|
Inhibition of Platelet Aggregation (IPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP) at 6 Hours After the Loading Dose
|
74.81 percent inhibition
Standard Deviation 13.01
|
31.77 percent inhibition
Standard Deviation 21.07
|
PRIMARY outcome
Timeframe: after 14 days of maintenance dosingPopulation: Includes patients who received a loading dose and underwent percutaneous coronary intervention (PCI) regardless of GP IIb/IIIa antagonist use (this includes subjects who received prasugrel and clopidogrel, in either order, during crossover)
Measures IPA during maintenance dosing before and after cross-over for each therapy. IPA was defined as (1 - \[maximal platelet aggregation(MPA) at 14 days after study drug treatment\]/\[MPA before drug treatment\]) x 100.
Outcome measures
| Measure |
Prasugrel
n=85 Participants
Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
|
Clopidogrel
n=86 Participants
Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to the administration of any maintenance dose.
|
|---|---|---|
|
Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate After 14 Days of Maintenance Dose Treatment
|
61.34 percent inhibition
Standard Deviation 17.84
|
46.06 percent inhibition
Standard Deviation 21.34
|
SECONDARY outcome
Timeframe: 2 hours after loading dosePopulation: Includes all patients who received a loading dose of study drug, did not receive a GP IIb/IIIa antagonist and had evaluable pretreatment and 2 hour MPA measurements. Patients had received a single loading dose of either 60-mg prasugrel or 600-mg clopidogrel but had not yet received any maintenance dosing.
IPA was defined as (1 - \[maximal platelet aggregation (MPA) at 2 hours after study drug treatment\]/\[MPA before drug treatment\]) x 100.
Outcome measures
| Measure |
Prasugrel
n=74 Participants
Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
|
Clopidogrel
n=78 Participants
Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to the administration of any maintenance dose.
|
|---|---|---|
|
Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate at 2 Hours After the Loading Dose
|
64.54 percent inhibition
Standard Deviation 20.43
|
20.32 percent inhibition
Standard Deviation 20.22
|
SECONDARY outcome
Timeframe: after 14 days of treatment (before cross-over)Population: Patients received a single loading dose and 14 days of maintenance therapy. Patients had not yet crossed-over to the alternate maintenance dose.
Non-CABG-related TIMI major bleeding was any intracranial hemorrhage OR any clinically overt bleeding associated with a fall in hemoglobin \>=5 gm/dL. Non-CABG-related TIMI minor bleeding was any clinically overt bleeding associated with a fall in hemoglobin \>=3 gm/dL but \<5 gm/dL.
Outcome measures
| Measure |
Prasugrel
n=102 Participants
Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
|
Clopidogrel
n=99 Participants
Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to the administration of any maintenance dose.
|
|---|---|---|
|
Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the First Maintenance Dose Phase
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 14 days after cross-overPopulation: All patients who received a loading dose of study drug, received maintenance therapy for 14 days and then switched to the alternate maintenance therapy.
Non-CABG-related TIMI major bleeding was any intracranial hemorrhage OR any clinically overt bleeding associated with a fall in hemoglobin \>=5 gm/dL. Non-CABG-related TIMI minor bleeding was any clinically overt bleeding associated with a fall in hemoglobin \>=3 gm/dL but \<5 gm/dL.
Outcome measures
| Measure |
Prasugrel
n=53 Participants
Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
|
Clopidogrel
n=55 Participants
Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to the administration of any maintenance dose.
|
|---|---|---|
|
Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the Crossover Maintenance Dose Phase
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: after 14 days of treatment (before cross-over)Population: Includes all patients who received a loading dose. Patients who underwent PCI also received 14 days of maintenance treatment. Patients had not yet crossed-over to the alternate maintenance treatment.
Number of patients who met any of the following endpoints: cardiovascular death, myocardial infarction, stroke, subacute stent thrombosis, or urgent target vessel revascularization
Outcome measures
| Measure |
Prasugrel
n=102 Participants
Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
|
Clopidogrel
n=99 Participants
Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to the administration of any maintenance dose.
|
|---|---|---|
|
Number of Participants With Major Adverse Cardiac Events (MACE) During the First Maintenance Dose Phase
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 14 days after cross-overPopulation: Includes all patients who received a loading dose and underwent PCI, received a maintenance dose for 14 days, and then crossed-over to the alternate therapy for an additional 14 days of maintenance dosing.
Number of patients who met any of the following endpoints: cardiovascular death, myocardial infarction, stroke, subacute stent thrombosis, or urgent target vessel revascularization
Outcome measures
| Measure |
Prasugrel
n=53 Participants
Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
|
Clopidogrel
n=55 Participants
Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to the administration of any maintenance dose.
|
|---|---|---|
|
Number of Participants With Major Adverse Cardiac Events During the Crossover Maintenance Dose Phase
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 hours after loading dosePopulation: Includes patients who received a loading dose of the study drug, did not receive a glycoprotein (GP) IIb/IIIa antagonist and had evaluable pre-treatment, and 6 hour MPA measurements. Patients had received a single loading dose of either 60-mg prasugrel or 600-mg clopidogrel but had not yet received any maintenance dosing.
Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) \<20%
Outcome measures
| Measure |
Prasugrel
n=72 Participants
Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
|
Clopidogrel
n=77 Participants
Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to the administration of any maintenance dose.
|
|---|---|---|
|
Number of Hyporesponsive Participants at 6 Hours After the Loading Dose
|
0 participants
|
21 participants
|
SECONDARY outcome
Timeframe: From loading dose to day 15Population: Includes patients who received a single loading dose and had evaluable MPA measures, regardless of glycoprotein (GP) IIb/IIIa antagonist use. Patients had received 14 days of maintenance treatment but had not crossed-over to the alternate maintenance treatment.
Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) \<20%
Outcome measures
| Measure |
Prasugrel
n=40 Participants
Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
|
Clopidogrel
n=46 Participants
Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to the administration of any maintenance dose.
|
|---|---|---|
|
Number of Hyporesponsive Participants at the End of the First Maintenance Dose Phase
|
1 participants
|
7 participants
|
SECONDARY outcome
Timeframe: 14 days after cross-overPopulation: Includes patients who received a single loading dose and had evaluable MPA measures,regardless of glycoprotein (GP) IIb/IIIa antagonist use. Patients received 14 days of maintenance treatment and then crossed-over to the alternate maintenance treatment for 14 days.
Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) \<20%
Outcome measures
| Measure |
Prasugrel
n=40 Participants
Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
|
Clopidogrel
n=45 Participants
Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to the administration of any maintenance dose.
|
|---|---|---|
|
Number of Hyporesponsive Participants at the End of the Crossover Maintenance Dose Phase
|
4 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 2 hours after loading dosePopulation: Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had evaluable VASP measurements. Patients had received a single loading dose but had not yet received any maintenance treatment.
VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI). PRI was defined as \[(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100\] where MFI is mean fluorescence index. A lower PRI indicates greater antiplatelet effect.
Outcome measures
| Measure |
Prasugrel
n=93 Participants
Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
|
Clopidogrel
n=88 Participants
Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to the administration of any maintenance dose.
|
|---|---|---|
|
Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) at 2 Hours After the Loading Dose
|
21.5 percent (%) platelet reactivity index
Standard Deviation 27.06
|
75.0 percent (%) platelet reactivity index
Standard Deviation 16.91
|
SECONDARY outcome
Timeframe: 6 hours after loading dosePopulation: Includes patients who received a loading dose, underwent PCI, and had evaluable VASP measurements, and did not receive a GP IIb/IIIa antagonist. Patients had received a single loading dose but had not yet received any maintenance treatment.
VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI). PRI was defined as \[(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100\] where MFI is mean fluorescence index. A lower PRI indicates greater antiplatelet effect.
Outcome measures
| Measure |
Prasugrel
n=68 Participants
Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
|
Clopidogrel
n=68 Participants
Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to the administration of any maintenance dose.
|
|---|---|---|
|
Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) at 6 Hours After the Loading Dose
|
7.4 percent (%) platelet reactivity index
Standard Deviation 16.66
|
68.4 percent (%) platelet reactivity index
Standard Deviation 21.18
|
SECONDARY outcome
Timeframe: 18 to 24 hours after loading dosePopulation: Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had evaluable VASP measurements.
VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI). PRI was defined as \[(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100\] where MFI is mean flourescence index. A lower PRI indicates greater antiplatelet effect.
Outcome measures
| Measure |
Prasugrel
n=48 Participants
Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
|
Clopidogrel
n=54 Participants
Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to the administration of any maintenance dose.
|
|---|---|---|
|
Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) 18 to 24 Hours After the Loading Dose
|
10.3 percent (%) platelet reactivity index
Standard Deviation 15.63
|
64.3 percent (%) platelet reactivity index
Standard Deviation 18.72
|
SECONDARY outcome
Timeframe: after 14 days of maintenance dosingPopulation: Includes patients who received a loading dose and PCI, regardless of GP IIb/IIIa antagonist use (this includes subjects who received prasugrel and clopidogrel, in either order, during crossover)
VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI). PRI was defined as \[(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100\] where MFI is mean fluorescence index. A lower PRI indicates greater antiplatelet effect.
Outcome measures
| Measure |
Prasugrel
n=100 Participants
Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
|
Clopidogrel
n=103 Participants
Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to the administration of any maintenance dose.
|
|---|---|---|
|
Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) After 14 Days of Maintenance Dose Treatment
|
23.4 percent (%) platelet reactivity index
Standard Deviation 19.19
|
43.8 percent (%) platelet reactivity index
Standard Deviation 23.26
|
SECONDARY outcome
Timeframe: 6 hours after loading dosePopulation: Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had an evaluable CK-MB measure.
Mean CK-MB at 6 hours after loading dose. CK-MB is a biomarker for myonecrosis
Outcome measures
| Measure |
Prasugrel
n=45 Participants
Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
|
Clopidogrel
n=51 Participants
Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to the administration of any maintenance dose.
|
|---|---|---|
|
Myonecrosis Measure: Creatine Kinase-Myocardial Bands (CK-MB) at 6 Hours After the Loading Dose
|
9.16 IU/L
Standard Deviation 8.3
|
8.13 IU/L
Standard Deviation 5.16
|
SECONDARY outcome
Timeframe: 18 to 24 hours after loading dosePopulation: Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had an evaluable CK-MB measure.
Mean CK-MB at 18-24 hours after loading dose. CK-MB is a biomarker for myonecrosis.
Outcome measures
| Measure |
Prasugrel
n=47 Participants
Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
|
Clopidogrel
n=51 Participants
Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to the administration of any maintenance dose.
|
|---|---|---|
|
Myonecrosis Measure: Creatine Kinase-Myocardial Bands (CK-MB) 18 to 24 Hours After the Loading Dose
|
11.64 IU/L
Standard Deviation 8.22
|
11.16 IU/L
Standard Deviation 8.72
|
SECONDARY outcome
Timeframe: 6 hours after loading dosePopulation: Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had an evaluable troponin measure.
Mean troponin level at 6 hours after the loading dose. Troponin is a biomarker for myonecrosis.
Outcome measures
| Measure |
Prasugrel
n=46 Participants
Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
|
Clopidogrel
n=50 Participants
Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to the administration of any maintenance dose.
|
|---|---|---|
|
Myonecrosis Measure: Cardiac Troponin at 6 Hours After the Loading Dose
|
0.06 ng/ml
Standard Deviation 0.204
|
0.05 ng/ml
Standard Deviation 0.128
|
SECONDARY outcome
Timeframe: 18 to 24 hours after loading dosePopulation: Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had an evaluable troponin measure.
Mean troponin level at 18 to 24 hours after the loading dose. Troponin is a biomarker for myonecrosis.
Outcome measures
| Measure |
Prasugrel
n=44 Participants
Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
|
Clopidogrel
n=49 Participants
Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to the administration of any maintenance dose.
|
|---|---|---|
|
Myonecrosis Measure: Cardiac Troponin 18 to 24 Hours After the Loading Dose
|
0.12 ng/ml
Standard Deviation 0.273
|
0.13 ng/ml
Standard Deviation 0.277
|
Adverse Events
Prasugrel Before Cross-over
Serious events: 8 serious events
Other events: 40 other events
Deaths: 0 deaths
Clopidogrel Before Cross-over
Serious events: 7 serious events
Other events: 40 other events
Deaths: 0 deaths
Prasugrel After Cross-over
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Clopidogrel After Cross-over
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prasugrel Before Cross-over
n=102 participants at risk
One time oral loading dose (LD) of 60 mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by prasugrel 10 mg and placebo matched to clopidogrel (prasugrel maintenance dose) once daily for 14 days.
|
Clopidogrel Before Cross-over
n=99 participants at risk
One time oral loading dose of 600 mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by 150 mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) once daily for 14 days.
|
Prasugrel After Cross-over
n=55 participants at risk
Prasugrel 10 mg and placebo matched to clopidogrel (prasugrel maintenance dose)once daily for 14 days after cross-over from one time loading dose of clopidogrel 600 mg and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by clopidogrel 150 mg and placebo matched to prasugrel (clopidogrel maintenance dose) once daily for 14 days
|
Clopidogrel After Cross-over
n=53 participants at risk
Clopidogrel 150 mg and placebo matched to prasugrel (clopidogrel maintenance dose) once daily for 14 days after cross-over from one time loading dose of 60 mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by 10 mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) once daily for 14 days.
|
|---|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/102
|
0.00%
0/99
|
0.00%
0/55
|
1.9%
1/53 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
0.00%
0/55
|
0.00%
0/53
|
|
Investigations
Blood glucose increased
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
0.00%
0/55
|
0.00%
0/53
|
|
Infections and infestations
Borrelia infection
|
0.00%
0/102
|
0.00%
0/99
|
0.00%
0/55
|
1.9%
1/53 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
0.00%
0/55
|
0.00%
0/53
|
|
General disorders
Chest discomfort
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
General disorders
Chest pain
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonmary disease
|
0.00%
0/102
|
0.00%
0/99
|
0.00%
0/55
|
1.9%
1/53 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
0.00%
0/55
|
0.00%
0/53
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Vascular disorders
Hypotension
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
1.8%
1/55 • Number of events 1
|
0.00%
0/53
|
|
Injury, poisoning and procedural complications
Post procedural myocardial infarction
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
0.00%
0/55
|
0.00%
0/53
|
|
Nervous system disorders
Syncope
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/102
|
0.00%
0/99
|
0.00%
0/55
|
1.9%
1/53 • Number of events 1
|
|
Nervous system disorders
VIth nerve disorder
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Cardiac disorders
Ventricular fibrillation
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
0.00%
0/55
|
0.00%
0/53
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
General disorders
Vessel puncture site haematoma
|
2.0%
2/102 • Number of events 2
|
0.00%
0/99
|
0.00%
0/55
|
0.00%
0/53
|
Other adverse events
| Measure |
Prasugrel Before Cross-over
n=102 participants at risk
One time oral loading dose (LD) of 60 mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by prasugrel 10 mg and placebo matched to clopidogrel (prasugrel maintenance dose) once daily for 14 days.
|
Clopidogrel Before Cross-over
n=99 participants at risk
One time oral loading dose of 600 mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by 150 mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) once daily for 14 days.
|
Prasugrel After Cross-over
n=55 participants at risk
Prasugrel 10 mg and placebo matched to clopidogrel (prasugrel maintenance dose)once daily for 14 days after cross-over from one time loading dose of clopidogrel 600 mg and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by clopidogrel 150 mg and placebo matched to prasugrel (clopidogrel maintenance dose) once daily for 14 days
|
Clopidogrel After Cross-over
n=53 participants at risk
Clopidogrel 150 mg and placebo matched to prasugrel (clopidogrel maintenance dose) once daily for 14 days after cross-over from one time loading dose of 60 mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by 10 mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) once daily for 14 days.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Gastrointestinal disorders
Abdominal distension
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
0.00%
0/55
|
0.00%
0/53
|
|
Gastrointestinal disorders
Abdominal pain
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
0.00%
0/55
|
0.00%
0/53
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
2/102 • Number of events 2
|
0.00%
0/99
|
0.00%
0/55
|
0.00%
0/53
|
|
Vascular disorders
Aneurysm
|
0.98%
1/102 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
1.9%
1/53 • Number of events 1
|
|
Vascular disorders
Arteriovenous fistula
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.98%
1/102 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
1.8%
1/55 • Number of events 1
|
0.00%
0/53
|
|
General disorders
Asthenia
|
0.00%
0/102
|
0.00%
0/99
|
0.00%
0/55
|
1.9%
1/53 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
0.00%
0/55
|
0.00%
0/53
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.9%
4/102 • Number of events 4
|
4.0%
4/99 • Number of events 4
|
3.6%
2/55 • Number of events 2
|
0.00%
0/53
|
|
Investigations
Blood magnesium decreased
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
0.00%
0/55
|
0.00%
0/53
|
|
Investigations
Blood pressure decreased
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
0.00%
0/55
|
0.00%
0/53
|
|
Investigations
Blood pressure orthostatic
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
0.00%
0/55
|
0.00%
0/53
|
|
Cardiac disorders
Bradycardia
|
2.0%
2/102 • Number of events 2
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Investigations
Cardiac enzymes increased
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
General disorders
Catheter site discharge
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
0.00%
0/55
|
0.00%
0/53
|
|
General disorders
Catheter site haematoma
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
General disorders
Chest discomfort
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
0.00%
0/55
|
0.00%
0/53
|
|
General disorders
Chest pain
|
3.9%
4/102 • Number of events 4
|
3.0%
3/99 • Number of events 3
|
3.6%
2/55 • Number of events 2
|
3.8%
2/53 • Number of events 2
|
|
Investigations
Coagulation time prolonged
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Injury, poisoning and procedural complications
Contusion
|
0.98%
1/102 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
1.8%
1/55 • Number of events 2
|
0.00%
0/53
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
0.00%
0/55
|
1.9%
1/53 • Number of events 1
|
|
Infections and infestations
Cystitis
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
0.00%
0/55
|
0.00%
0/53
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Eye disorders
Diplopia
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
General disorders
Discomfort
|
2.0%
2/102 • Number of events 2
|
3.0%
3/99 • Number of events 3
|
0.00%
0/55
|
0.00%
0/53
|
|
Nervous system disorders
Dizziness
|
2.9%
3/102 • Number of events 3
|
2.0%
2/99 • Number of events 2
|
1.8%
1/55 • Number of events 1
|
0.00%
0/53
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
0.00%
0/55
|
0.00%
0/53
|
|
Gastrointestinal disorders
Dyspepsia
|
0.98%
1/102 • Number of events 1
|
4.0%
4/99 • Number of events 4
|
0.00%
0/55
|
0.00%
0/53
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.98%
1/102 • Number of events 1
|
2.0%
2/99 • Number of events 3
|
1.8%
1/55 • Number of events 1
|
3.8%
2/53 • Number of events 2
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/102
|
1.0%
1/99 • Number of events 2
|
0.00%
0/55
|
0.00%
0/53
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Reproductive system and breast disorders
Epistaxis
|
2.9%
3/102 • Number of events 3
|
2.0%
2/99 • Number of events 2
|
3.6%
2/55 • Number of events 2
|
0.00%
0/53
|
|
Gastrointestinal disorders
Eructation
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
0.00%
0/55
|
0.00%
0/53
|
|
General disorders
Fatigue
|
0.98%
1/102 • Number of events 1
|
3.0%
3/99 • Number of events 3
|
0.00%
0/55
|
0.00%
0/53
|
|
Vascular disorders
Femoral artery aneurysm
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
0.00%
0/55
|
0.00%
0/53
|
|
Gastrointestinal disorders
Flatulence
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
0.00%
0/55
|
0.00%
0/53
|
|
Vascular disorders
Flushing
|
0.00%
0/102
|
0.00%
0/99
|
0.00%
0/55
|
1.9%
1/53 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/102
|
0.00%
0/99
|
0.00%
0/55
|
1.9%
1/53 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
3.9%
4/102 • Number of events 4
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Vascular disorders
Haematoma
|
3.9%
4/102 • Number of events 4
|
1.0%
1/99 • Number of events 1
|
1.8%
1/55 • Number of events 1
|
0.00%
0/53
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Investigations
Haemoglobin decreased
|
2.0%
2/102 • Number of events 2
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
0.00%
0/55
|
0.00%
0/53
|
|
Vascular disorders
Haemorrhage
|
0.98%
1/102 • Number of events 1
|
2.0%
2/99 • Number of events 2
|
0.00%
0/55
|
0.00%
0/53
|
|
Nervous system disorders
Headache
|
2.9%
3/102 • Number of events 3
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
1.9%
1/53 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Vascular disorders
Hypertension
|
0.98%
1/102 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Vascular disorders
Hypotension
|
4.9%
5/102 • Number of events 5
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Injury, poisoning and procedural complications
Incision site complications
|
2.9%
3/102 • Number of events 3
|
0.00%
0/99
|
0.00%
0/55
|
0.00%
0/53
|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
0.00%
0/102
|
2.0%
2/99 • Number of events 2
|
0.00%
0/55
|
0.00%
0/53
|
|
Psychiatric disorders
Insomnia
|
2.0%
2/102 • Number of events 2
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Infections and infestations
Lower respiratiry tract infection
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
0.00%
0/55
|
0.00%
0/53
|
|
General disorders
Malaise
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Psychiatric disorders
Middle insomnia
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/102
|
0.00%
0/99
|
1.8%
1/55 • Number of events 1
|
0.00%
0/53
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.98%
1/102 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
3.6%
2/55 • Number of events 2
|
0.00%
0/53
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/102
|
4.0%
4/99 • Number of events 4
|
1.8%
1/55 • Number of events 1
|
0.00%
0/53
|
|
Infections and infestations
Nasopharyngitis
|
0.98%
1/102 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
1.9%
1/53 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
2.9%
3/102 • Number of events 3
|
3.0%
3/99 • Number of events 3
|
3.6%
2/55 • Number of events 2
|
0.00%
0/53
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/102
|
0.00%
0/99
|
1.8%
1/55 • Number of events 1
|
0.00%
0/53
|
|
General disorders
Oedema peripheral
|
2.0%
2/102 • Number of events 2
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.98%
1/102 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
General disorders
Pain
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.98%
1/102 • Number of events 1
|
2.0%
2/99 • Number of events 2
|
0.00%
0/55
|
0.00%
0/53
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/102
|
0.00%
0/99
|
0.00%
0/55
|
1.9%
1/53 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
0.00%
0/55
|
0.00%
0/53
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
General disorders
Puncture site pain
|
0.98%
1/102 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
1.8%
1/55 • Number of events 1
|
0.00%
0/53
|
|
Infections and infestations
Rash pustular
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/102
|
0.00%
0/99
|
0.00%
0/55
|
1.9%
1/53 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
0.00%
0/102
|
0.00%
0/99
|
1.8%
1/55 • Number of events 1
|
0.00%
0/53
|
|
General disorders
Swelling
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
0.00%
0/55
|
0.00%
0/53
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
0.00%
0/55
|
0.00%
0/53
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/102
|
0.00%
0/99
|
0.00%
0/55
|
1.9%
1/53 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/102
|
0.00%
0/99
|
1.8%
1/55 • Number of events 1
|
0.00%
0/53
|
|
Renal and urinary disorders
Urinary retention
|
0.98%
1/102 • Number of events 2
|
0.00%
0/99
|
0.00%
0/55
|
0.00%
0/53
|
|
Infections and infestations
Urinary tract infection
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
0.00%
0/55
|
0.00%
0/53
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/102
|
0.00%
0/99
|
1.8%
1/55 • Number of events 1
|
0.00%
0/53
|
|
General disorders
Vessel puncture site haematoma
|
2.0%
2/102 • Number of events 2
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Infections and infestations
Viral infection
|
0.00%
0/102
|
0.00%
0/99
|
1.8%
1/55 • Number of events 1
|
0.00%
0/53
|
|
Gastrointestinal disorders
Vomiting
|
0.98%
1/102 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
0.00%
0/55
|
0.00%
0/53
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
0.00%
0/55
|
0.00%
0/53
|
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