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| ID | Type | Description | Link |
|---|---|---|---|
| H7T-MC-TABL | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| Daiichi Sankyo | INDUSTRY |
| The TIMI Study Group | OTHER |
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The purpose of this study is to provide information of the relative potency of prasugrel and clopidogrel on platelet function studies, inflammation, and myocyte necrosis in subjects undergoing elective percutaneous coronary intervention (PCI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prasugrel to Clopidogrel | Experimental | 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 10-mg Prasugrel and placebo matched to clopidogrel taken orally once a day for 14 days. Patients cross-over to 150 mg clopidogrel and placebo matched to prasugrel taken orally once a day for the next 14 days. |
|
| Clopidogrel to Prasugrel | Active Comparator | One time oral LD 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 taken orally once a day for 14 days. Patients cross-over to 10 mg prasugrel and placebo tablets matched to clopidogrel taken orally once a day for the next 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prasugrel | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inhibition of Platelet Aggregation (IPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP) at 6 Hours After the Loading Dose | IPA was defined as (1 - [maximal platelet aggregation(MPA) at 6 hours after study drug treatment]/[MPA before drug treatment]) x 100. | 6 hours after loading dose |
| Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate After 14 Days of Maintenance Dose Treatment | 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. | after 14 days of maintenance dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate at 2 Hours After the Loading Dose | IPA was defined as (1 - [maximal platelet aggregation (MPA) at 2 hours after study drug treatment]/[MPA before drug treatment]) x 100. | 2 hours after loading 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 |
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Inclusion Criteria:
Subjects greater than or equal to 18 years of age undergoing cardiac catheterization with planned percutaneous coronary intervention (if coronary anatomy is suitable) for an indication of chest pain +/or anginal equivalent felt by the treating physician to be related to coronary ischemia.
At least one of the following (a through c):
Functional study (exercise, or pharmacologic) within the past 8 weeks consistent with ischemia as manifested by at least one of the following:
Prior coronary revascularization [percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)].
A cardiac catheterization with at least one coronary artery lesion amenable to PCI (not yet performed) within 14 days prior to enrollment.
Exclusion Criteria:
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| 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, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Jacksonville | Florida | 32209 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Maintenance Dose Phase |
|
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| Clopidogrel | Drug | Administered orally |
|
| Placebo for Prasugrel | Drug | Administered orally |
|
| Placebo for Clopidogrel | Drug | Administered orally |
|
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. |
| after 14 days of treatment (before cross-over) |
| 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 | 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. | 14 days after cross-over |
| Number of Participants With Major Adverse Cardiac Events (MACE) During the First Maintenance Dose Phase | Number of patients who met any of the following endpoints: cardiovascular death, myocardial infarction, stroke, subacute stent thrombosis, or urgent target vessel revascularization | after 14 days of treatment (before cross-over) |
| Number of Participants With Major Adverse Cardiac Events During the Crossover Maintenance Dose Phase | Number of patients who met any of the following endpoints: cardiovascular death, myocardial infarction, stroke, subacute stent thrombosis, or urgent target vessel revascularization | 14 days after cross-over |
| Number of Hyporesponsive Participants at 6 Hours After the Loading Dose | Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) <20% | 6 hours after loading dose |
| Number of Hyporesponsive Participants at the End of the First Maintenance Dose Phase | Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) <20% | From loading dose to day 15 |
| Number of Hyporesponsive Participants at the End of the Crossover Maintenance Dose Phase | Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) <20% | 14 days after cross-over |
| Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) at 2 Hours After the Loading Dose | 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. | 2 hours after loading dose |
| Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) at 6 Hours After the Loading Dose | 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. | 6 hours after loading dose |
| Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) 18 to 24 Hours After the Loading Dose | 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. | 18 to 24 hours after loading dose |
| Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) After 14 Days of Maintenance Dose 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. | after 14 days of maintenance dosing |
| Myonecrosis Measure: Creatine Kinase-Myocardial Bands (CK-MB) at 6 Hours After the Loading Dose | Mean CK-MB at 6 hours after loading dose. CK-MB is a biomarker for myonecrosis | 6 hours after loading dose |
| Myonecrosis Measure: Creatine Kinase-Myocardial Bands (CK-MB) 18 to 24 Hours After the Loading Dose | Mean CK-MB at 18-24 hours after loading dose. CK-MB is a biomarker for myonecrosis. | 18 to 24 hours after loading dose |
| Myonecrosis Measure: Cardiac Troponin at 6 Hours After the Loading Dose | Mean troponin level at 6 hours after the loading dose. Troponin is a biomarker for myonecrosis. | 6 hours after loading dose |
| Myonecrosis Measure: Cardiac Troponin 18 to 24 Hours After the Loading Dose | Mean troponin level at 18 to 24 hours after the loading dose. Troponin is a biomarker for myonecrosis. | 18 to 24 hours after loading dose |
| United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Worcester | Massachusetts | 01655 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ann Arbor | Michigan | 48109 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Rapid City | South Dakota | 57701 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lille | 59037 | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Marseille | 13385 | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Paris | 75013 | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tours | 37044 | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bad Krozingen | D-79189 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Berlin | D-12203 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Giessen | 35392 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | München | D-80636 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tübingen | 72076 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Haifa | 31096 | Israel |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Jerusalem | 91120 | Israel |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tel Litwinsky | 52621 | Israel |
| FG001 | 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). |
| Received Loading Dose |
|
| Percutaneous Coronary Intervention (PCI) |
|
| Started Maintenance Dose |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
| Crossover Maintenance Dose Phase |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| BG001 | 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) 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| 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 | Inhibition of Platelet Aggregation (IPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP) at 6 Hours After the Loading Dose | IPA was defined as (1 - [maximal platelet aggregation(MPA) at 6 hours after study drug treatment]/[MPA before drug treatment]) x 100. | 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. | Posted | Mean | Standard Deviation | percent inhibition | 6 hours after loading dose |
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| Primary | Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate After 14 Days of Maintenance Dose Treatment | 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. | 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) | Posted | Mean | Standard Deviation | percent inhibition | after 14 days of maintenance dosing |
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| Secondary | Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate at 2 Hours After the Loading Dose | IPA was defined as (1 - [maximal platelet aggregation (MPA) at 2 hours after study drug treatment]/[MPA before drug treatment]) x 100. | 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. | Posted | Mean | Standard Deviation | percent inhibition | 2 hours after loading dose |
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| Secondary | 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 | 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. | Patients received a single loading dose and 14 days of maintenance therapy. Patients had not yet crossed-over to the alternate maintenance dose. | Posted | Number | participants | after 14 days of treatment (before cross-over) |
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| Secondary | 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 | 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. | All patients who received a loading dose of study drug, received maintenance therapy for 14 days and then switched to the alternate maintenance therapy. | Posted | Number | participants | 14 days after cross-over |
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| Secondary | Number of Participants With Major Adverse Cardiac Events (MACE) During the First Maintenance Dose Phase | Number of patients who met any of the following endpoints: cardiovascular death, myocardial infarction, stroke, subacute stent thrombosis, or urgent target vessel revascularization | 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. | Posted | Number | participants | after 14 days of treatment (before cross-over) |
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| Secondary | Number of Participants With Major Adverse Cardiac Events During the Crossover Maintenance Dose Phase | Number of patients who met any of the following endpoints: cardiovascular death, myocardial infarction, stroke, subacute stent thrombosis, or urgent target vessel revascularization | 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. | Posted | Number | participants | 14 days after cross-over |
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| Secondary | Number of Hyporesponsive Participants at 6 Hours After the Loading Dose | Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) <20% | 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. | Posted | Number | participants | 6 hours after loading dose |
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| Secondary | Number of Hyporesponsive Participants at the End of the First Maintenance Dose Phase | Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) <20% | 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. | Posted | Number | participants | From loading dose to day 15 |
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| Secondary | Number of Hyporesponsive Participants at the End of the Crossover Maintenance Dose Phase | Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) <20% | 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. | Posted | Number | participants | 14 days after cross-over |
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| Secondary | Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) at 2 Hours After the Loading Dose | 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. | 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. | Posted | Mean | Standard Deviation | percent (%) platelet reactivity index | 2 hours after loading dose |
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| Secondary | Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) at 6 Hours After the Loading Dose | 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. | 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. | Posted | Mean | Standard Deviation | percent (%) platelet reactivity index | 6 hours after loading dose |
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| Secondary | Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) 18 to 24 Hours After the Loading Dose | 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. | Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had evaluable VASP measurements. | Posted | Mean | Standard Deviation | percent (%) platelet reactivity index | 18 to 24 hours after loading dose |
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| Secondary | Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) After 14 Days of Maintenance Dose 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. | 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) | Posted | Mean | Standard Deviation | percent (%) platelet reactivity index | after 14 days of maintenance dosing |
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| Secondary | Myonecrosis Measure: Creatine Kinase-Myocardial Bands (CK-MB) at 6 Hours After the Loading Dose | Mean CK-MB at 6 hours after loading dose. CK-MB is a biomarker for myonecrosis | Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had an evaluable CK-MB measure. | Posted | Mean | Standard Deviation | IU/L | 6 hours after loading dose |
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| Secondary | Myonecrosis Measure: Creatine Kinase-Myocardial Bands (CK-MB) 18 to 24 Hours After the Loading Dose | Mean CK-MB at 18-24 hours after loading dose. CK-MB is a biomarker for myonecrosis. | Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had an evaluable CK-MB measure. | Posted | Median | Standard Deviation | IU/L | 18 to 24 hours after loading dose |
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| Secondary | Myonecrosis Measure: Cardiac Troponin at 6 Hours After the Loading Dose | Mean troponin level at 6 hours after the loading dose. Troponin is a biomarker for myonecrosis. | Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had an evaluable troponin measure. | Posted | Mean | Standard Deviation | ng/ml | 6 hours after loading dose |
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| Secondary | Myonecrosis Measure: Cardiac Troponin 18 to 24 Hours After the Loading Dose | Mean troponin level at 18 to 24 hours after the loading dose. Troponin is a biomarker for myonecrosis. | Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had an evaluable troponin measure. | Posted | Mean | Standard Deviation | ng/ml | 18 to 24 hours after loading dose |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prasugrel Before Cross-over | 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. | 8 | 102 | 40 | 102 | ||
| EG001 | Clopidogrel Before Cross-over | 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. | 7 | 99 | 40 | 99 | ||
| EG002 | Prasugrel After Cross-over | 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 | 1 | 55 | 16 | 55 | ||
| EG003 | Clopidogrel After Cross-over | 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. | 3 | 53 | 12 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Blood glucose increased | Investigations | Systematic Assessment |
| ||
| Borrelia infection | Infections and infestations | Systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Chest discomfort | General disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Chronic obstructive pulmonmary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Extrasystoles | Cardiac disorders | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Non-cardiac chest pain | General disorders | Systematic Assessment |
| ||
| Post procedural myocardial infarction | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| VIth nerve disorder | Nervous system disorders | Systematic Assessment |
| ||
| Ventricular fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Ventricular tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Vessel puncture site haematoma | General disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
| ||
| Aneurysm | Vascular disorders | Systematic Assessment |
| ||
| Angina pectoris | Cardiac disorders | Systematic Assessment |
| ||
| Arteriovenous fistula | Vascular disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Blood magnesium decreased | Investigations | Systematic Assessment |
| ||
| Blood pressure decreased | Investigations | Systematic Assessment |
| ||
| Blood pressure orthostatic | Investigations | Systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac enzymes increased | Investigations | Systematic Assessment |
| ||
| Catheter site discharge | General disorders | Systematic Assessment |
| ||
| Catheter site haematoma | General disorders | Systematic Assessment |
| ||
| Catheter site haemorrhage | General disorders | Systematic Assessment |
| ||
| Chest discomfort | General disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Coagulation time prolonged | Investigations | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cystitis | Infections and infestations | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diplopia | Eye disorders | Systematic Assessment |
| ||
| Discomfort | General disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Dyslipidaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dysuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Ecchymosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Epistaxis | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Eructation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Femoral artery aneurysm | Vascular disorders | Systematic Assessment |
| ||
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
| ||
| Flushing | Vascular disorders | Systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Systematic Assessment |
| ||
| Groin pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Haematoma | Vascular disorders | Systematic Assessment |
| ||
| Haematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Haemoglobin decreased | Investigations | Systematic Assessment |
| ||
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Haemorrhage | Vascular disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Hypersensitivity | Immune system disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Hypothyroidism | Endocrine disorders | Systematic Assessment |
| ||
| Incision site complications | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Incision site haematoma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Joint stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Lower respiratiry tract infection | Infections and infestations | Systematic Assessment |
| ||
| Malaise | General disorders | Systematic Assessment |
| ||
| Middle insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Oedema peripheral | General disorders | Systematic Assessment |
| ||
| Operative haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Paraesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Post procedural haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Puncture site pain | General disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash pustular | Infections and infestations | Systematic Assessment |
| ||
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Systematic Assessment |
| ||
| Swelling | General disorders | Systematic Assessment |
| ||
| Swelling face | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Syncope vasovagal | Nervous system disorders | Systematic Assessment |
| ||
| Thrombophlebitis | Vascular disorders | Systematic Assessment |
| ||
| Tooth abscess | Infections and infestations | Systematic Assessment |
| ||
| Toothache | Gastrointestinal disorders | Systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Vertigo positional | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Vessel puncture site haematoma | General disorders | Systematic Assessment |
| ||
| Viral infection | Infections and infestations | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Wound secretion | Injury, poisoning and procedural complications | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068799 | Prasugrel Hydrochloride |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D011725 | Pyridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| >=65 years |
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| Male |
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| Israel |
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