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| ID | Type | Description | Link |
|---|---|---|---|
| H7T-MC-TACA | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| Daiichi Sankyo | INDUSTRY |
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This trial is designed as a phase 2 randomized, double-blind double dummy, active comparator controlled, two-period two-arm crossover study to enroll 40 patients across multiple centers. The study will compare platelet function following a prasugrel loading dose and 1 week of prasugrel maintenance therapy with high-dose clopidogrel loading dose and 1 week of high-dose clopidogrel maintenance therapy in patients with drug treated type 2 diabetes mellitus who have coronary artery disease. Various assays of platelet function will be used in this study. Platelet function will be studied using the following assays: Accumetrics VerifyNowTM P2Y12, Light Transmittance Aggregometry (LTA), Vasodilator-associated stimulated phosphoprotein (VASP), and Thromboelastography (TEG)-platelet mapping.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prasugrel | Experimental | Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose. |
|
| Clopidogrel | Active Comparator | Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prasugrel | Drug | Oral prasugrel 60-mg loading dose, followed by 6-9 days of oral prasugrel 10-mg/day tablet maintenance dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inhibition of Platelet Aggregation (IPA) 4 Hours After Loading Dose Assessed by Accumetrics VerifyNowâ„¢ P2Y12 Assay | The inhibition of platelet aggregation 4 hours after the loading dose was administered was assessed using the Accumetrics VerifyNowâ„¢ P2Y12 assay. Percentage inhibition, as reported by VerifyNowâ„¢ P2Y12, was calculated from P2Y12 Reaction Unit (PRU) (rate and extent of adenosine diphosphate [ADP]-stimulated platelet aggregation) and BASE (estimate of baseline platelet reactivity independent of P2Y12 receptor inhibition [reference values]: rate and extent of Thrombin Receptor-Activated Peptide-stimulated platelet aggregation) values as follows: Percentage (%) inhibition = (1-PRU/BASE) x 100. | 4 hours after loading dose |
| Measure | Description | Time Frame |
|---|---|---|
| Inhibition of Platelet Aggregation at 1- and 24-Hours After Loading Dose (LD) and 24-Hours After Last Maintenance Dose (LMD) Assessed by Accumetrics VerifyNowâ„¢ P2Y12 Assay | Inhibition of platelet aggregation 1- and 24-hours after loading dose and 24-hours after last maintenance dose was administered was assessed using Accumetrics VerifyNowâ„¢ P2Y12 assay. Percentage inhibition, as reported by VerifyNowâ„¢ P2Y12, was calculated from PRU (rate and extent of ADP-stimulated platelet aggregation) and BASE (estimate of baseline platelet reactivity independent of P2Y12 receptor inhibition [reference values]: rate and extent of Thrombin Receptor-Activated Peptide-stimulated platelet aggregation) values as follows: Percentage (%) inhibition = (1-PRU/BASE) x 100. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9am-5pm 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21252171 | Derived | Angiolillo DJ, Badimon JJ, Saucedo JF, Frelinger AL, Michelson AD, Jakubowski JA, Zhu B, Ojeh CK, Baker BA, Effron MB. A pharmacodynamic comparison of prasugrel vs. high-dose clopidogrel in patients with type 2 diabetes mellitus and coronary artery disease: results of the Optimizing anti-Platelet Therapy In diabetes MellitUS (OPTIMUS)-3 Trial. Eur Heart J. 2011 Apr;32(7):838-46. doi: 10.1093/eurheartj/ehq494. Epub 2011 Jan 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prasugrel Then Clopidogrel | Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose. Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose. |
| FG001 | Clopidogrel Then Prasugrel | Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose. Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 - Initial Drug |
|
| ||||||||||||||||||
| Period 2 - Crossover Drug |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prasugrel Then Clopidogrel | Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose. Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose. |
| BG001 | Clopidogrel Then Prasugrel |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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) 4 Hours After Loading Dose Assessed by Accumetrics VerifyNowâ„¢ P2Y12 Assay | The inhibition of platelet aggregation 4 hours after the loading dose was administered was assessed using the Accumetrics VerifyNowâ„¢ P2Y12 assay. Percentage inhibition, as reported by VerifyNowâ„¢ P2Y12, was calculated from P2Y12 Reaction Unit (PRU) (rate and extent of adenosine diphosphate [ADP]-stimulated platelet aggregation) and BASE (estimate of baseline platelet reactivity independent of P2Y12 receptor inhibition [reference values]: rate and extent of Thrombin Receptor-Activated Peptide-stimulated platelet aggregation) values as follows: Percentage (%) inhibition = (1-PRU/BASE) x 100. | Pharmacodynamic Population, which included all randomized participants who had blood draws for IPA at 4 hours, who met compliance criteria, and who had last dose of study drug prior to the blood draw for IPA. | Posted | Least Squares Mean | 95% Confidence Interval | percent inhibition | 4 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 | Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000068799 | Prasugrel Hydrochloride |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
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| Clopidogrel | Drug | Oral clopidogrel 600-mg loading dose, followed by 6-9 days of oral clopidogrel 150-mg/day tablet maintenance dose. |
|
| 1 hour and 24 hours after the loading dose (LD) and 24 hours after the last maintenance dose (LMD) |
| Maximum Platelet Aggregation (MPA) as Assessed by Light Transmittance Aggregometry (LTA) | Mean platelet aggregation (MPA) to 5 and 20 µM adenosine diphosphate (ADP) was assessed by light transmittance aggregometry (LTA). Platelet aggregation was monitored for a total of 7 minutes after addition of ADP. Maximum platelet aggregation was the maximal aggregation value achieved during the 7-minute observation period following addition of agonists. | Baseline, 1 Hour, 4 Hours, and 24 Hours after loading dose, and 24 Hours after last maintenance dose |
| Platelet Reactivity Index (PRI) | Data from the Vasodilator-associated stimulated phosphoprotein assay were reported as the platelet reactivity index (PRI) which was calculated from corrected mean fluorescence intensity (cMFI) following incubation of platelets with either prostaglandin E1 (PGE1) alone or PGE1 plus ADP: Platelet Reactivity Index (%) = [1-(cMFI PGEI+ADP/cMFI PGEI)] x 100. Lower PRI values indicate greater platelet P2Y12 inhibition. | Baseline, 1 Hour, 4 Hours, and 24 Hours after loading dose, and 24 Hours after last maintenance dose |
| Inhibition of Platelet Function as Measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate | Thromboelastography (TEG) platelet mapping (MP) maximum amplitude (MA) - Adenosine Diphosphate (ADP) millimeters (mm) at each time point. The TEG-MP MA measures strength of clot formation in whole blood. MA-ADP is the maximal amplitude resulting from fibrin and platelets not blocked by ADP-receptor inhibiting drugs. Fibrin strands in blood sample link a rotating sample cup with a stationary pin suspended by a torsion wire. The degree of platelet contribution to the MA through platelet-fibrin bonding directly influences the magnitude of pin movement and ultimately the amplitude of the tracing. | Baseline, 1 Hour, 4 Hours, and 24 Hours after loading dose, and 24 Hours after last maintenance 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. | New York | New York | 10029 | 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. | Oklahoma City | Oklahoma | 73104 | United States |
| NOT COMPLETED |
|
Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose. Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Prasugrel |
Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose. |
| OG001 | Clopidogrel | Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose. |
|
|
|
| Secondary | Inhibition of Platelet Aggregation at 1- and 24-Hours After Loading Dose (LD) and 24-Hours After Last Maintenance Dose (LMD) Assessed by Accumetrics VerifyNowâ„¢ P2Y12 Assay | Inhibition of platelet aggregation 1- and 24-hours after loading dose and 24-hours after last maintenance dose was administered was assessed using Accumetrics VerifyNowâ„¢ P2Y12 assay. Percentage inhibition, as reported by VerifyNowâ„¢ P2Y12, was calculated from PRU (rate and extent of ADP-stimulated platelet aggregation) and BASE (estimate of baseline platelet reactivity independent of P2Y12 receptor inhibition [reference values]: rate and extent of Thrombin Receptor-Activated Peptide-stimulated platelet aggregation) values as follows: Percentage (%) inhibition = (1-PRU/BASE) x 100. | Pharmacodynamic Population, which included all randomized participants who had blood draws for IPA, who met compliance criteria, and who had last dose of study drug prior to the blood draw for IPA. | Posted | Least Squares Mean | 95% Confidence Interval | percent inhibition | 1 hour and 24 hours after the loading dose (LD) and 24 hours after the last maintenance dose (LMD) |
|
|
|
|
| Secondary | Maximum Platelet Aggregation (MPA) as Assessed by Light Transmittance Aggregometry (LTA) | Mean platelet aggregation (MPA) to 5 and 20 µM adenosine diphosphate (ADP) was assessed by light transmittance aggregometry (LTA). Platelet aggregation was monitored for a total of 7 minutes after addition of ADP. Maximum platelet aggregation was the maximal aggregation value achieved during the 7-minute observation period following addition of agonists. | Pharmacodynamic Population, which included all randomized participants who had blood draws for MPA, who met compliance criteria, and who had last dose of study drug prior to the blood draw for MPA. | Posted | Least Squares Mean | 95% Confidence Interval | percent platelet aggregation | Baseline, 1 Hour, 4 Hours, and 24 Hours after loading dose, and 24 Hours after last maintenance dose |
|
|
|
|
| Secondary | Platelet Reactivity Index (PRI) | Data from the Vasodilator-associated stimulated phosphoprotein assay were reported as the platelet reactivity index (PRI) which was calculated from corrected mean fluorescence intensity (cMFI) following incubation of platelets with either prostaglandin E1 (PGE1) alone or PGE1 plus ADP: Platelet Reactivity Index (%) = [1-(cMFI PGEI+ADP/cMFI PGEI)] x 100. Lower PRI values indicate greater platelet P2Y12 inhibition. | Pharmacodynamic Population, which included all randomized participants who had blood draws for Vasodilator-Associated Stimulated Phosphoprotein (VASP), who met compliance criteria, and who had last dose of study drug prior to the blood draw for inhibition of platelet function as assessed by VASP. | Posted | Least Squares Mean | 95% Confidence Interval | percent inhibition | Baseline, 1 Hour, 4 Hours, and 24 Hours after loading dose, and 24 Hours after last maintenance dose |
|
|
|
|
| Secondary | Inhibition of Platelet Function as Measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate | Thromboelastography (TEG) platelet mapping (MP) maximum amplitude (MA) - Adenosine Diphosphate (ADP) millimeters (mm) at each time point. The TEG-MP MA measures strength of clot formation in whole blood. MA-ADP is the maximal amplitude resulting from fibrin and platelets not blocked by ADP-receptor inhibiting drugs. Fibrin strands in blood sample link a rotating sample cup with a stationary pin suspended by a torsion wire. The degree of platelet contribution to the MA through platelet-fibrin bonding directly influences the magnitude of pin movement and ultimately the amplitude of the tracing. | Pharmacodynamic Population, which included all randomized participants who had blood draws for Inhibition of Platelet Function (IPF) as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP), who met compliance criteria, and who had last dose of study drug prior to blood draw for IPF. | Posted | Least Squares Mean | 95% Confidence Interval | millimeters (mm) | Baseline, 1 Hour, 4 Hours, and 24 Hours after loading dose, and 24 Hours after last maintenance dose |
|
|
|
|
| 0 |
| 34 |
| 5 |
| 34 |
| EG001 | Clopidogrel | Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose. | 0 | 35 | 9 | 35 |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Vessel puncture site haemorrhage | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Wart excision | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
Not provided
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D011725 | Pyridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| 24 Hours After Last Maintenance Dose |
|
| Null hypothesis: there was no difference between prasugrel and clopidogrel in IPA assessed by Accumetrics VerifyNowâ„¢ P2Y12 24 hours after administration of the loading dose. | Mixed Models Analysis | Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect. | <0.0001 | P-value for 24 Hour After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level. | Mean Difference (Net) | 57.9 | 95 | 49.56 | 66.19 | Least Squares Mean Difference = Prasugrel minus Clopidogrel. | No | Superiority or Other |
| Null hypothesis: there was no difference between prasugrel and clopidogrel in IPA assessed by Accumetrics VerifyNowâ„¢ P2Y12 24 hours post-Last Maintenance Dose (LMD). | Mixed Models Analysis | Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect. | <0.0001 | P-value for 24 Hours After Last Maintenance Dose. A priori threshold for statistical significance was set at p=0.05 level. | Mean Difference (Net) | 17.7 | 95 | 10.27 | 25.04 | Least Squares Mean Difference = Prasugrel minus Clopidogrel. | No | Superiority or Other |
| 4 Hours After Loading Dose (5 μM ADP) |
|
| 24 Hours After Loading Dose (5 μM ADP) |
|
| 24 Hours After Last Maintenance Dose (5 μM ADP) |
|
| Baseline (20 μM ADP) |
|
| 1 Hour After Loading Dose (20 μM ADP) |
|
| 4 Hours After Loading Dose (20 μM ADP) |
|
| 24 Hours After Loading Dose (20 μM ADP) |
|
| 24 Hours After Last Maintenance Dose (20 μM ADP) |
|
| The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA). | Mixed Models Analysis | Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect. | <0.0001 | P-value for 1 After Post Loading Dose (5 uM ADP). A priori threshold for statistical significance was set at p=0.05 level. | Mean Difference (Net) | -23.0 | 95 | -28.45 | -17.55 | Least Squares Mean Difference = Prasugrel minus Clopidogrel. | No | Superiority or Other |
| The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA). | Mixed Models Analysis | Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect. | <0.0001 | P-value for 4 Hour After Loading Dose (5 uM ADP). A priori threshold for statisitical significance was set at p=0.05 level. | Mean Difference (Net) | -26.6 | 95 | -31.18 | -22.02 | Least Squares Mean Difference = Prasugrel minus Clopidogrel. | No | Superiority or Other |
| The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA). | Mixed Models Analysis | Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect. | <0.0001 | P-value for 24 Hour After Loading Dose (5 uM ADP). A priori threshold for statistical significance was set at p=0.05 level. | Mean Difference (Net) | -23.3 | 95 | -27.42 | -19.17 | Least Squares Mean Difference = Prasugrel minus Clopidogrel. | No | Superiority or Other |
| The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA). | Mixed Models Analysis | Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect. | 0.0001 | P-value for 24 Hour After Last Maintenance Dose (5 uM ADP). A priori threshold for statistical significance was set at p=0.05 level. | Mean Difference (Net) | -8.7 | 95 | -12.78 | -4.58 | Least Squares Mean Difference = Prasugrel minus Clopidogrel. | No | Superiority or Other |
| The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA). | Mixed Models Analysis | Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect. | 0.8779 | P-value for Baseline (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level. | Mean Difference (Net) | 0.2 | 95 | -2.80 | 3.26 | Least Squares Mean Difference = Prasugrel minus Clopidogrel. | No | Superiority or Other |
| The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA). | Mixed Models Analysis | Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect. | <0.0001 | P-value for 1 Hour After Loading Dose (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level. | Mean Difference (Net) | -25.2 | 95 | -32.43 | -17.87 | Least Squares Mean Difference = Prasugrel minus Clopidogrel. | No | Superiority or Other |
| The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA). | Mixed Models Analysis | Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect. | <0.0001 | P-value for 4 Hour After Loading Dose (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level. | Mean Difference (Net) | -35.1 | 95 | -40.32 | -29.78 | Least Squares Mean Difference = Prasugrel minus Clopidogrel. | No | Superiority or Other |
| The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA). | Mixed Models Analysis | Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect. | <0.0001 | P-value for 24 Hour After Loading Dose (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level. | Mean Difference (Net) | -31.0 | 95 | -36.32 | -25.66 | Least Squares Mean Difference = Prasugrel minus Clopidogrel. | No | Superiority or Other |
| The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA). | Mixed Models Analysis | Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect. | <0.0001 | P-value for 24 Hour After Last Maintenance Dose (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level. | Mean Difference (Net) | -12.4 | 95 | -17.19 | -7.58 | Least Squares Mean Difference = Prasugrel minus Clopidogrel. | No | Superiority or Other |
| 4 Hours After Loading Dose |
|
| 24 Hours After Loading Dose |
|
| 24 Hours After Last Maintenance Dose |
|
| The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP. | Mixed Models Analysis | Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect. | <0.0001 | P-value for 1 Hour After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level. | Mean Difference (Net) | -36.2 | 95 | -47.43 | -24.98 | Least Squares Mean Difference = Prasugrel minus Clopidogrel. | No | Superiority or Other |
| The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP. | Mixed Models Analysis | Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect. | <0.0001 | P-value for 4 Hours After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level. | Mean Difference (Net) | -53.0 | 95 | -61.89 | -44.02 | Least Squares Mean Difference = Prasugrel minus Clopidogrel. | No | Superiority or Other |
| The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP. | Mixed Models Analysis | Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect. | <0.0001 | P-value for 24 Hours After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level. | Mean Difference (Net) | -42.8 | 95 | -50.03 | -35.55 | Least Squares Mean Difference = Prasugrel minus Clopidogrel. | No | Superiority or Other |
| The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP. | Mixed Models Analysis | Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect. | 0.0012 | P-value for 24 Hours After Last Maintenance Dose. A priori threshold for statistical significance was set to p=0.05 level. | Mean Difference (Net) | -14.9 | 95 | -23.42 | -6.37 | Least Squares Mean Difference = Prasugrel minus Clopidogrel. | No | Superiority or Other |
| 4 Hours After Loading Dose |
|
| 24 Hours After Loading Dose |
|
| 24 Hours After Last Maintenance Dose |
|
| Superiority or Other |
| Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP). | Mixed Models Analysis | Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect. | <0.0001 | P-value for 1 Hour After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level. | Mean Difference (Net) | -16.2 | 95 | -21.15 | -11.33 | Least Squares Mean Difference = Prasugrel minus Clopidogrel. | No | Superiority or Other |
| Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP). | Mixed Models Analysis | Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect. | <0.0001 | P-value for 4 Hours After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level. | Mean Difference (Net) | -23.9 | 95 | -29.67 | -18.11 | Least Squares Mean Difference = Prasugrel minus Clopidogrel. | No | Superiority or Other |
| Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP). | Mixed Models Analysis | Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect. | <0.0001 | P-value for 24 Hours After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level. | Mean Difference (Net) | -19.9 | 95 | -24.97 | -14.90 | Least Squares Mean Difference = Prasugrel minus Clopidogrel. | No | Superiority or Other |
| Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP). | Mixed Models Analysis | Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect. | 0.3725 | P-value for 24 Hours After Last Maintenance Dose. A priori threshold for statistical significance was set at p=0.05 level. | Mean Difference (Net) | -2.6 | 95 | -8.46 | 3.26 | Least Squares Mean Difference = Prasugrel minus Clopidogrel. | No | Superiority or Other |