Trial Outcomes & Findings for A Trial of CS-747 (Prasugrel) Compared With Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention (PCI) (NCT NCT00059215)
NCT ID: NCT00059215
Last Updated: 2010-05-25
Results Overview
Number of participants with non-coronary artery bypass graft (non-CABG) Thrombolysis In Myocardial Infarction (TIMI) Major or Minor bleeding. A major bleed was defined as an intracranial hemorrhage OR a clinically overt hemorrhage with a \>5 g/dL decrease in hemoglobin. A minor bleed was defined as a clinically overt hemorrhage with a hemoglobin decrease \>=3 g/dL and \<= 5 g/dL.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
905 participants
Primary outcome timeframe
randomization though 30 days after percutaneous coronary intervention (PCI)
Results posted on
2010-05-25
Participant Flow
Participant milestones
| Measure |
Prasugrel (CS-747) 40-mg LD/7.5 mg MD
Prasugrel (CS-747) 40 mg oral loading dose (LD) at time of percutaneous coronary intervention (PCI) followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days
|
Prasugrel (CS-747) 60-mg LD/10-mg MD
Prasugrel (CS-747) 60-mg oral loading dose (LD) at time of PCI followed by 10-mg oral maintenance dose (MD), once daily, for 29-34 days
|
Prasugrel (CS-747) 60-mg LD/15-mg MD
Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days
|
Clopidogrel
Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
200
|
200
|
251
|
254
|
|
Overall Study
COMPLETED
|
187
|
186
|
236
|
239
|
|
Overall Study
NOT COMPLETED
|
13
|
14
|
15
|
15
|
Reasons for withdrawal
| Measure |
Prasugrel (CS-747) 40-mg LD/7.5 mg MD
Prasugrel (CS-747) 40 mg oral loading dose (LD) at time of percutaneous coronary intervention (PCI) followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days
|
Prasugrel (CS-747) 60-mg LD/10-mg MD
Prasugrel (CS-747) 60-mg oral loading dose (LD) at time of PCI followed by 10-mg oral maintenance dose (MD), once daily, for 29-34 days
|
Prasugrel (CS-747) 60-mg LD/15-mg MD
Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days
|
Clopidogrel
Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
5
|
9
|
9
|
|
Overall Study
Death
|
0
|
0
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
1
|
3
|
|
Overall Study
Protocol Violation
|
1
|
0
|
1
|
0
|
|
Overall Study
Protocol entry criteria not met
|
1
|
1
|
0
|
2
|
|
Overall Study
Physician Decision
|
1
|
2
|
1
|
1
|
Baseline Characteristics
A Trial of CS-747 (Prasugrel) Compared With Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention (PCI)
Baseline characteristics by cohort
| Measure |
Prasugrel (CS-747) 40 mg LD/7.5 mg MD
n=199 Participants
Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of percutaneous coronary intervention (PCI) followed by 7.5-mg oral maintenance dose (MD), once daily, for 29-34 days
|
Prasugrel (CS-747) 60 mg LD/10 mg MD
n=200 Participants
Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days
|
Prasugrel (CS-747) 60-mg LD/15-mg MD
n=251 Participants
Prasugrel (CS-747) 60-mg oral loading dose (LD) at time of PCI followed by 15-mg oral maintenance dose (MD), once daily, for 29-34 days
|
Clopidogrel
n=254 Participants
Clopidogrel 300-mg oral LD at time of PCI followed by an oral 75-mg MD; taken once a day
|
Total
n=904 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<=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, Customized
>18 and <= 65 years
|
129 participants
n=5 Participants
|
152 participants
n=7 Participants
|
185 participants
n=5 Participants
|
195 participants
n=4 Participants
|
661 participants
n=21 Participants
|
|
Age, Customized
> 65 years
|
70 participants
n=5 Participants
|
48 participants
n=7 Participants
|
66 participants
n=5 Participants
|
59 participants
n=4 Participants
|
243 participants
n=21 Participants
|
|
Age Continuous
|
60.4 years
STANDARD_DEVIATION 8.72 • n=5 Participants
|
58.7 years
STANDARD_DEVIATION 9.15 • n=7 Participants
|
59.4 years
STANDARD_DEVIATION 8.97 • n=5 Participants
|
58.4 years
STANDARD_DEVIATION 9.17 • n=4 Participants
|
59.2 years
STANDARD_DEVIATION 9.03 • n=21 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
208 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
152 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
195 Participants
n=4 Participants
|
696 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African descent
|
10 participants
n=5 Participants
|
14 participants
n=7 Participants
|
15 participants
n=5 Participants
|
9 participants
n=4 Participants
|
48 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Western Asian
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
10 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
180 participants
n=5 Participants
|
180 participants
n=7 Participants
|
226 participants
n=5 Participants
|
238 participants
n=4 Participants
|
824 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
East/Southeast Asian
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
2 participants
n=4 Participants
|
16 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
43 participants
n=5 Participants
|
44 participants
n=7 Participants
|
48 participants
n=5 Participants
|
46 participants
n=4 Participants
|
181 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
156 participants
n=5 Participants
|
156 participants
n=7 Participants
|
203 participants
n=5 Participants
|
208 participants
n=4 Participants
|
723 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: randomization though 30 days after percutaneous coronary intervention (PCI)Population: Patients who received at least one dose of study drug
Number of participants with non-coronary artery bypass graft (non-CABG) Thrombolysis In Myocardial Infarction (TIMI) Major or Minor bleeding. A major bleed was defined as an intracranial hemorrhage OR a clinically overt hemorrhage with a \>5 g/dL decrease in hemoglobin. A minor bleed was defined as a clinically overt hemorrhage with a hemoglobin decrease \>=3 g/dL and \<= 5 g/dL.
Outcome measures
| Measure |
Prasugrel (CS-747) 40-mg LD/7.5-mg MD
n=199 Participants
Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of PCI followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days
|
Prasugrel (CS-747) 60-mg LD/10-mg MD
n=200 Participants
Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days
|
Prasugrel (CS-747) 60-mg LD/15-mg MD
n=251 Participants
Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days
|
Clopidogrel
n=254 Participants
Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
|
Prasugrel (CS-747) Combined
n=650 Participants
All evaluable patients in the 3 prasugrel (CS-747) treatment arms
|
|---|---|---|---|---|---|
|
Number of Participants With Non-coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding Events
|
3 participants
|
4 participants
|
4 participants
|
3 participants
|
11 participants
|
SECONDARY outcome
Timeframe: randomization though 30 days after percutaneous coronary intervention (PCI)Number of participants with any of the following: death, nonfatal myocardial infarction, stroke, total or subtotal occlusion of the target vessel, urgent target vessel revascularization, recurrent ischemia requiring hospitalization.
Outcome measures
| Measure |
Prasugrel (CS-747) 40-mg LD/7.5-mg MD
n=199 Participants
Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of PCI followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days
|
Prasugrel (CS-747) 60-mg LD/10-mg MD
n=200 Participants
Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days
|
Prasugrel (CS-747) 60-mg LD/15-mg MD
n=251 Participants
Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days
|
Clopidogrel
n=254 Participants
Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
|
Prasugrel (CS-747) Combined
n=650 Participants
All evaluable patients in the 3 prasugrel (CS-747) treatment arms
|
|---|---|---|---|---|---|
|
Number of Participants With Major Adverse Cardiovascular Events (MACE)
|
15 participants
|
15 participants
|
17 participants
|
24 participants
|
47 participants
|
SECONDARY outcome
Timeframe: randomization though 30 days after percutaneous coronary intervention (PCI)Number of participants with non-coronary artery bypass graft (non-CABG) Thrombolysis In Myocardial Infarction (TIMI) Major or Minor bleeding. A major bleed was defined as an intracranial hemorrhage OR a clinically overt hemorrhage with a \>5 g/dL decrease in hemoglobin.
Outcome measures
| Measure |
Prasugrel (CS-747) 40-mg LD/7.5-mg MD
n=199 Participants
Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of PCI followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days
|
Prasugrel (CS-747) 60-mg LD/10-mg MD
n=200 Participants
Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days
|
Prasugrel (CS-747) 60-mg LD/15-mg MD
n=251 Participants
Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days
|
Clopidogrel
n=254 Participants
Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
|
Prasugrel (CS-747) Combined
n=650 Participants
All evaluable patients in the 3 prasugrel (CS-747) treatment arms
|
|---|---|---|---|---|---|
|
Number of Participants With Non-Coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
|
1 participants
|
1 participants
|
1 participants
|
2 participants
|
3 participants
|
SECONDARY outcome
Timeframe: randomization though 30 days after percutaneous coronary intervention (PCI)Number of participants with non-coronary artery bypass graft (non-CABG) Thrombolysis In Myocardial Infarction (TIMI) Major or Minor bleeding or MACE. Major bleed was defined as an intracranial hemorrhage OR a clinically overt hemorrhage with a \>5 g/dL decrease in hemoglobin. Minor bleed was defined as a clinically overt hemorrhage with a hemoglobin decrease \>=3 g/dL and \<= 5 g/dL. MACE is any of the following:death, nonfatal myocardial infarction, stroke, total or subtotal occlusion of the target vessel, urgent target vessel revascularization, recurrent ischemia requiring hospitalization
Outcome measures
| Measure |
Prasugrel (CS-747) 40-mg LD/7.5-mg MD
n=199 Participants
Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of PCI followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days
|
Prasugrel (CS-747) 60-mg LD/10-mg MD
n=200 Participants
Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days
|
Prasugrel (CS-747) 60-mg LD/15-mg MD
n=251 Participants
Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days
|
Clopidogrel
n=254 Participants
Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
|
Prasugrel (CS-747) Combined
n=650 Participants
All evaluable patients in the 3 prasugrel (CS-747) treatment arms
|
|---|---|---|---|---|---|
|
Number of Participants With Non-CABG TIMI Major or Minor Bleeding Plus MACE
|
17 participants
|
19 participants
|
20 participants
|
27 participants
|
56 participants
|
Adverse Events
Prasugrel (CS-747) 40-mg LD/7.5 mg MD
Serious events: 17 serious events
Other events: 147 other events
Deaths: 0 deaths
Prasugrel (CS-747) 60-mg LD/10 mg MD
Serious events: 9 serious events
Other events: 157 other events
Deaths: 0 deaths
Prasugrel (CS-747) 60-mg LD/15-mg MD
Serious events: 18 serious events
Other events: 192 other events
Deaths: 0 deaths
Clopidogrel
Serious events: 22 serious events
Other events: 195 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prasugrel (CS-747) 40-mg LD/7.5 mg MD
n=199 participants at risk
Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of PCI followed by 7.5-mg oral maintenance dose (MD), once daily, for 29-34 days
|
Prasugrel (CS-747) 60-mg LD/10 mg MD
n=200 participants at risk
Prasugrel (CS-747) 60-mg oral loading dose (LD) at time of PCI followed by 10-mg oral maintenance dose (MD), once daily, for 29-34 days
|
Prasugrel (CS-747) 60-mg LD/15-mg MD
n=251 participants at risk
Prasugrel (CS-747) 60-mg oral loading dose (LD) at time of PCI followed by 15-mg oral maintenance dose (MD), once daily, for 29-34 days
|
Clopidogrel
n=254 participants at risk
Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
|
|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/199
|
0.00%
0/200
|
0.00%
0/251
|
0.39%
1/254 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/199
|
0.00%
0/200
|
0.00%
0/251
|
0.39%
1/254 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia nos
|
0.00%
0/199
|
0.50%
1/200 • Number of events 1
|
0.00%
0/251
|
0.00%
0/254
|
|
Cardiac disorders
Angina pectoris
|
0.50%
1/199 • Number of events 1
|
0.00%
0/200
|
0.40%
1/251 • Number of events 1
|
0.00%
0/254
|
|
Skin and subcutaneous tissue disorders
Angioneurotic oedema
|
0.00%
0/199
|
0.00%
0/200
|
0.40%
1/251 • Number of events 1
|
0.00%
0/254
|
|
Vascular disorders
Arterial haemorrhage nos
|
0.00%
0/199
|
0.50%
1/200 • Number of events 1
|
0.00%
0/251
|
0.00%
0/254
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/199
|
0.00%
0/200
|
0.40%
1/251 • Number of events 2
|
0.39%
1/254 • Number of events 1
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/199
|
0.00%
0/200
|
0.00%
0/251
|
0.39%
1/254 • Number of events 1
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/199
|
0.50%
1/200 • Number of events 1
|
0.00%
0/251
|
0.00%
0/254
|
|
Investigations
Blood in stool
|
0.00%
0/199
|
0.50%
1/200 • Number of events 1
|
0.00%
0/251
|
0.00%
0/254
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/199
|
0.50%
1/200 • Number of events 1
|
0.00%
0/251
|
0.00%
0/254
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/199
|
0.50%
1/200 • Number of events 1
|
0.00%
0/251
|
0.00%
0/254
|
|
Investigations
Cardiac output decreased
|
0.00%
0/199
|
0.00%
0/200
|
0.40%
1/251 • Number of events 1
|
0.00%
0/254
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/199
|
0.50%
1/200 • Number of events 1
|
0.00%
0/251
|
0.00%
0/254
|
|
General disorders
Catheter site haemorrhage
|
1.0%
2/199 • Number of events 2
|
0.00%
0/200
|
0.00%
0/251
|
0.39%
1/254 • Number of events 1
|
|
General disorders
Chest pain
|
3.0%
6/199 • Number of events 6
|
1.0%
2/200 • Number of events 2
|
2.4%
6/251 • Number of events 6
|
2.0%
5/254 • Number of events 5
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/199
|
0.00%
0/200
|
0.40%
1/251 • Number of events 1
|
0.00%
0/254
|
|
Cardiac disorders
Coronary artery dissection
|
1.0%
2/199 • Number of events 2
|
0.00%
0/200
|
0.40%
1/251 • Number of events 1
|
0.00%
0/254
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.00%
0/199
|
0.00%
0/200
|
0.00%
0/251
|
0.39%
1/254 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/199
|
0.50%
1/200 • Number of events 1
|
0.00%
0/251
|
0.00%
0/254
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.50%
1/199 • Number of events 1
|
0.00%
0/200
|
0.00%
0/251
|
0.00%
0/254
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage nos
|
0.00%
0/199
|
0.50%
1/200 • Number of events 1
|
1.2%
3/251 • Number of events 3
|
0.39%
1/254 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/199
|
0.00%
0/200
|
0.00%
0/251
|
0.39%
1/254 • Number of events 1
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/199
|
0.50%
1/200 • Number of events 1
|
0.00%
0/251
|
0.00%
0/254
|
|
Investigations
Haematocrit decreased
|
0.00%
0/199
|
0.00%
0/200
|
0.00%
0/251
|
0.79%
2/254 • Number of events 2
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/199
|
0.00%
0/200
|
0.00%
0/251
|
0.79%
2/254 • Number of events 2
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/199
|
0.00%
0/200
|
0.00%
0/251
|
0.39%
1/254 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/199
|
0.00%
0/200
|
0.00%
0/251
|
0.39%
1/254 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia nos
|
0.00%
0/199
|
0.00%
0/200
|
0.00%
0/251
|
0.39%
1/254 • Number of events 1
|
|
Vascular disorders
Hypotension nos
|
0.00%
0/199
|
0.00%
0/200
|
0.00%
0/251
|
0.79%
2/254 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/199
|
0.00%
0/200
|
0.00%
0/251
|
0.79%
2/254 • Number of events 2
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/199
|
0.00%
0/200
|
0.00%
0/251
|
0.39%
1/254 • Number of events 1
|
|
Vascular disorders
Ischaemia nos
|
0.00%
0/199
|
0.50%
1/200 • Number of events 1
|
0.00%
0/251
|
0.00%
0/254
|
|
Cardiac disorders
Myocardial infarction
|
1.5%
3/199 • Number of events 3
|
0.50%
1/200 • Number of events 1
|
0.00%
0/251
|
0.39%
1/254 • Number of events 1
|
|
Cardiac disorders
Nodal rhythm
|
0.00%
0/199
|
0.00%
0/200
|
0.00%
0/251
|
0.39%
1/254 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/199
|
0.50%
1/200 • Number of events 1
|
0.00%
0/251
|
0.00%
0/254
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/199
|
0.00%
0/200
|
0.00%
0/251
|
0.39%
1/254 • Number of events 1
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/199
|
0.00%
0/200
|
0.00%
0/251
|
0.39%
1/254 • Number of events 1
|
|
Injury, poisoning and procedural complications
Scrotal haematoma
|
0.00%
0/199
|
0.50%
1/200 • Number of events 1
|
0.00%
0/251
|
0.00%
0/254
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/199
|
0.00%
0/200
|
0.00%
0/251
|
0.39%
1/254 • Number of events 1
|
|
General disorders
Sudden death
|
0.00%
0/199
|
0.00%
0/200
|
0.40%
1/251 • Number of events 1
|
0.00%
0/254
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.50%
1/199 • Number of events 1
|
0.00%
0/200
|
0.40%
1/251 • Number of events 1
|
0.00%
0/254
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/199
|
0.00%
0/200
|
0.00%
0/251
|
0.39%
1/254 • Number of events 1
|
|
Vascular disorders
Vascular pseudoaneurysm
|
1.0%
2/199 • Number of events 2
|
0.00%
0/200
|
0.40%
1/251 • Number of events 1
|
0.00%
0/254
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.50%
1/199 • Number of events 1
|
0.00%
0/200
|
0.00%
0/251
|
0.00%
0/254
|
Other adverse events
| Measure |
Prasugrel (CS-747) 40-mg LD/7.5 mg MD
n=199 participants at risk
Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of PCI followed by 7.5-mg oral maintenance dose (MD), once daily, for 29-34 days
|
Prasugrel (CS-747) 60-mg LD/10 mg MD
n=200 participants at risk
Prasugrel (CS-747) 60-mg oral loading dose (LD) at time of PCI followed by 10-mg oral maintenance dose (MD), once daily, for 29-34 days
|
Prasugrel (CS-747) 60-mg LD/15-mg MD
n=251 participants at risk
Prasugrel (CS-747) 60-mg oral loading dose (LD) at time of PCI followed by 15-mg oral maintenance dose (MD), once daily, for 29-34 days
|
Clopidogrel
n=254 participants at risk
Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
|
|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
9.0%
18/199 • Number of events 18
|
5.5%
11/200 • Number of events 11
|
6.0%
15/251 • Number of events 16
|
9.1%
23/254 • Number of events 25
|
|
Psychiatric disorders
Anxiety
|
6.0%
12/199 • Number of events 12
|
3.5%
7/200 • Number of events 8
|
4.4%
11/251 • Number of events 11
|
5.9%
15/254 • Number of events 15
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.5%
11/199 • Number of events 11
|
9.5%
19/200 • Number of events 19
|
11.2%
28/251 • Number of events 28
|
11.0%
28/254 • Number of events 29
|
|
Cardiac disorders
Bradycardia nos
|
2.5%
5/199 • Number of events 5
|
2.0%
4/200 • Number of events 4
|
6.4%
16/251 • Number of events 16
|
3.5%
9/254 • Number of events 10
|
|
General disorders
Catheter site discharge
|
4.0%
8/199 • Number of events 9
|
6.5%
13/200 • Number of events 13
|
4.4%
11/251 • Number of events 11
|
3.1%
8/254 • Number of events 8
|
|
General disorders
Catheter site ecchymosis
|
7.0%
14/199 • Number of events 14
|
7.5%
15/200 • Number of events 16
|
9.6%
24/251 • Number of events 24
|
4.7%
12/254 • Number of events 12
|
|
General disorders
Catheter site haemorrhage
|
13.6%
27/199 • Number of events 29
|
17.5%
35/200 • Number of events 36
|
14.7%
37/251 • Number of events 39
|
11.8%
30/254 • Number of events 31
|
|
General disorders
Chest pain
|
7.5%
15/199 • Number of events 15
|
10.5%
21/200 • Number of events 24
|
4.8%
12/251 • Number of events 12
|
7.5%
19/254 • Number of events 19
|
|
Skin and subcutaneous tissue disorders
Contusion
|
4.5%
9/199 • Number of events 9
|
6.5%
13/200 • Number of events 16
|
8.0%
20/251 • Number of events 22
|
4.3%
11/254 • Number of events 12
|
|
Nervous system disorders
Dizziness
|
5.5%
11/199 • Number of events 11
|
6.5%
13/200 • Number of events 13
|
4.8%
12/251 • Number of events 13
|
2.8%
7/254 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.0%
6/199 • Number of events 6
|
4.5%
9/200 • Number of events 11
|
5.6%
14/251 • Number of events 14
|
1.2%
3/254 • Number of events 3
|
|
Nervous system disorders
Headache
|
4.5%
9/199 • Number of events 11
|
6.0%
12/200 • Number of events 12
|
6.8%
17/251 • Number of events 18
|
5.9%
15/254 • Number of events 15
|
|
Vascular disorders
Hypertension nos
|
3.5%
7/199 • Number of events 7
|
5.5%
11/200 • Number of events 11
|
3.6%
9/251 • Number of events 9
|
3.1%
8/254 • Number of events 9
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.0%
10/199 • Number of events 10
|
1.5%
3/200 • Number of events 3
|
3.6%
9/251 • Number of events 9
|
3.1%
8/254 • Number of events 8
|
|
Vascular disorders
Hypotension nos
|
7.0%
14/199 • Number of events 14
|
5.5%
11/200 • Number of events 11
|
5.2%
13/251 • Number of events 13
|
6.7%
17/254 • Number of events 17
|
|
Psychiatric disorders
Insomnia
|
4.0%
8/199 • Number of events 8
|
5.5%
11/200 • Number of events 11
|
4.4%
11/251 • Number of events 11
|
6.3%
16/254 • Number of events 16
|
|
Gastrointestinal disorders
Nausea
|
9.0%
18/199 • Number of events 20
|
5.5%
11/200 • Number of events 11
|
9.2%
23/251 • Number of events 23
|
9.4%
24/254 • Number of events 26
|
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