Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H7T-MC-TAAH | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the effects of a drug known as CS-747 (also known as prasugrel) on subjects having a procedure called a percutaneous coronary intervention (also referred to as PCI) in which a doctor will attempt to open a blocked vessel (or vessels) in the heart using a catheter (a long thin tube) that has a small balloon on the end. In many cases, patients who have this procedure receive a stent, a small wire spring that helps keep the vessel open.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prasugrel (CS-747) 40 mg LD/7.5 mg MD | Experimental | 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 | Experimental | 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 | Experimental | 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 | Active Comparator | Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prasugrel (CS-747) | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Non-coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding Events | 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. | randomization though 30 days after percutaneous coronary intervention (PCI) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Major Adverse Cardiovascular Events (MACE) | 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. | randomization though 30 days after percutaneous coronary intervention (PCI) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Boston | Massachusetts |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | Clopidogrel | Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Prasugrel (CS-747) 60 mg LD/10 mg MD |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Non-coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding Events | 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. | Patients who received at least one dose of study drug | Posted | Number | participants | randomization though 30 days after percutaneous coronary intervention (PCI) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prasugrel (CS-747) 40-mg LD/7.5 mg MD | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000068799 | Prasugrel Hydrochloride |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Clopidogrel | Drug | Administered orally |
|
| Number of Participants With Non-Coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding | 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. | randomization though 30 days after percutaneous coronary intervention (PCI) |
| Number of Participants With Non-CABG TIMI Major or Minor Bleeding Plus MACE | 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 | randomization though 30 days after percutaneous coronary intervention (PCI) |
| United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4599) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Victoria | British Columbia | Canada |
| Death |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Protocol Violation |
|
| Protocol entry criteria not met |
|
| Physician Decision |
|
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 |
| BG002 | 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 |
| BG003 | Clopidogrel | Clopidogrel 300-mg oral LD at time of PCI followed by an oral 75-mg MD; taken once a day |
| BG004 | Total | Total of all reporting groups |
| participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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 |
| OG002 | 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 |
| OG003 | Clopidogrel | Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day. |
| OG004 | Prasugrel (CS-747) Combined | All evaluable patients in the 3 prasugrel (CS-747) treatment arms |
|
|
|
| Secondary | Number of Participants With Major Adverse Cardiovascular Events (MACE) | 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. | Posted | Number | participants | randomization though 30 days after percutaneous coronary intervention (PCI) |
|
|
|
|
| Secondary | Number of Participants With Non-Coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding | 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. | Posted | Number | participants | randomization though 30 days after percutaneous coronary intervention (PCI) |
|
|
|
|
| Secondary | Number of Participants With Non-CABG TIMI Major or Minor Bleeding Plus MACE | 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 | Posted | Number | participants | randomization though 30 days after percutaneous coronary intervention (PCI) |
|
|
|
|
| 17 |
| 199 |
| 147 |
| 199 |
| EG001 | 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 | 9 | 200 | 157 | 200 |
| EG002 | 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 | 18 | 251 | 192 | 251 |
| EG003 | Clopidogrel | Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day. | 22 | 254 | 195 | 254 |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Anaemia nos | Blood and lymphatic system disorders | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | Systematic Assessment |
|
| Angioneurotic oedema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Arterial haemorrhage nos | Vascular disorders | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | Systematic Assessment |
|
| Atrioventricular block second degree | Cardiac disorders | Systematic Assessment |
|
| Blood in stool | Investigations | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | Systematic Assessment |
|
| Cardiac output decreased | Investigations | Systematic Assessment |
|
| Cardiac tamponade | Cardiac disorders | Systematic Assessment |
|
| Catheter site haemorrhage | General disorders | Systematic Assessment |
|
| Chest pain | General disorders | Systematic Assessment |
|
| Circulatory collapse | Vascular disorders | Systematic Assessment |
|
| Coronary artery dissection | Cardiac disorders | Systematic Assessment |
|
| Coronary artery thrombosis | Cardiac disorders | Systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | Systematic Assessment |
|
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal haemorrhage nos | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | Systematic Assessment |
|
| Haematocrit decreased | Investigations | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hyperglycaemia nos | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypotension nos | Vascular disorders | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | Systematic Assessment |
|
| Ischaemia nos | Vascular disorders | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| Nodal rhythm | Cardiac disorders | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Retroperitoneal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Scrotal haematoma | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | Systematic Assessment |
|
| Sudden death | General disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
|
| Vascular pseudoaneurysm | Vascular disorders | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bradycardia nos | Cardiac disorders | Systematic Assessment |
|
| Catheter site discharge | General disorders | Systematic Assessment |
|
| Catheter site ecchymosis | General disorders | Systematic Assessment |
|
| Catheter site haemorrhage | General disorders | Systematic Assessment |
|
| Chest pain | General disorders | Systematic Assessment |
|
| Contusion | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Hypertension nos | Vascular disorders | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypotension nos | Vascular disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D011725 | Pyridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| 95 |
| No |
| Superiority or Other |
| 95 |
| No |
| Superiority or Other |