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| ID | Type | Description | Link |
|---|---|---|---|
| H7T-CR-TAEH | Other Identifier | Eli Lilly and Company | |
| CTRI/2010/091/000348 | Registry Identifier | India |
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This study will evaluate the use of a prasugrel 60 mg loading dose (LD) administered during percutaneous coronary intervention (PCI) with and without a prior LD of clopidogrel on platelet inhibition in patients presenting with acute coronary syndrome (ACS). Platelet inhibition following a prasugrel LD in clopidogrel pretreated patients' will be determined in a time-dependent manner for two different prasugrel loading doses (30 mg and 60 mg). Understanding the effects of this combination on platelet inhibition will provide guidance to physicians on the use of prasugrel in patients who have already been pretreated with clopidogrel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo and 60 milligram (mg) Prasugrel | Placebo Comparator | Placebo loading dose administered once orally before percutaneous coronary intervention (PCI) and 60-mg prasugrel loading dose administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after loading dose, then every 24 hours for 72 hours. |
|
| 600 mg Clopidogrel and 60 mg Prasugrel | Experimental | 600-mg clopidogrel loading dose administered once orally before PCI and 60-mg prasugrel loading dose administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after loading dose, then every 24 hours for 72 hours. |
|
| 600 mg Clopidogrel and 30 mg Prasugrel | Experimental | 600-mg clopidogrel loading dose administered once orally before PCI and 30-mg prasugrel loading dose administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after loading dose, then every 24 hours for 72 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prasugrel | Drug | Loading dose administered once orally and maintenance dose administered orally 24 hours after loading dose, then every 24 hours for 72 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-Mediated Platelet Aggregation 6 Hours After Prasugrel Loading Dose (LD) | ADP-induced P2Y12 receptor mediated platelet aggregation serves as a biomarker of platelet function. It is measured in P2Y12 Reaction Units (PRU) with lower PRU reflecting stronger inhibition of P2Y12 and reduced platelet aggregation. Least Squares (LS) Mean values were controlled for treatment, visit, treatment and visit interaction, and country. | 6 hours after prasugrel loading dose |
| Measure | Description | Time Frame |
|---|---|---|
| Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-Mediated Platelet Aggregation at Baseline, 2, 24 and 72 Hours After Prasugrel Loading Dose (LD) | ADP-induced P2Y12 receptor mediated platelet aggregation serves as a biomarker of platelet function. It is measured in P2Y12 Reaction Units (PRU) with lower PRU reflecting stronger inhibition of P2Y12 and reduced platelet aggregation. Least Squares (LS) Mean values were controlled for treatment, visit, treatment and visit interaction, and country. |
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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 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. | Bangalore | 560099 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24718367 | Derived | Diodati JG, Saucedo JF, Cardillo TE, Jakubowski JA, Henneges C, Effron MB, Lipkin FR, Walker JR, Duvvuru S, Sundseth SS, Fisher HN, Angiolillo DJ. Transferring from clopidogrel loading dose to prasugrel loading dose in acute coronary syndrome patients. High on-treatment platelet reactivity analysis of the TRIPLET trial. Thromb Haemost. 2014 Aug;112(2):311-22. doi: 10.1160/TH13-09-0747. Epub 2014 Apr 10. | |
| 24065443 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo and 60-mg Prasugrel | Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours. |
| FG001 | 600-mg Clopidogrel and 60-mg Prasugrel | 600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours. |
| FG002 | 600-mg Clopidogrel and 30-mg Prasugrel | 600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo and 60-mg Prasugrel | Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours. |
| BG001 |
| 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 | Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-Mediated Platelet Aggregation 6 Hours After Prasugrel Loading Dose (LD) | ADP-induced P2Y12 receptor mediated platelet aggregation serves as a biomarker of platelet function. It is measured in P2Y12 Reaction Units (PRU) with lower PRU reflecting stronger inhibition of P2Y12 and reduced platelet aggregation. Least Squares (LS) Mean values were controlled for treatment, visit, treatment and visit interaction, and country. | All randomized participants who received the prasugrel LD and had at least one evaluable PRU measurement after LD. | Posted | Least Squares Mean | Standard Error | PRU | 6 hours after prasugrel loading dose |
|
Not provided
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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 | Placebo and 60-mg Prasugrel | Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular 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 |
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|
| Clopidogrel | Drug | Loading dose administered once orally. |
|
| Placebo | Drug | Loading dose administered once orally |
|
| Baseline and 2 hours and 24 hours and 72 hours after prasugrel loading dose |
| Mean Change From Baseline to 72 Hours in Laboratory Measurements - Hematocrit | Baseline, 72 hours |
| Mean Change From Baseline to 72 Hours in Laboratory Measurements - Hemoglobin | Baseline, 72 hours |
| Percentage of Inhibition of Platelet Aggregation | Adenosine Diphosphate (ADP)-induced P2Y12 receptor mediated platelet aggregation serves as a biomarker of platelet function. It is measured in P2Y12 Reaction Units (PRU) with lower PRU reflecting stronger inhibition of P2Y12 and reduced platelet aggregation. The internal BASE standard is an independent measurement and serves as an estimate of the participant's baseline platelet aggregation independent of P2Y12 receptor inhibition. Percent Inhibition of Platelet Aggregation=(1-[PRU/BASE) x 100%, high numbers represent increased platelet inhibition. Least Squares (LS) Mean values were controlled for treatment, visit, treatment and visit interaction, and country.](streamdown:incomplete-link) | Baseline and 2 and 6 and 24 and 72 hours after loading dose |
| Percentage of Poor Responders | Poor responders are those who had P2Y12 Reaction Units (PRU)≥ 240. | Baseline and 2 and 6 and 24 and 72 hours after loading dose |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | TEAE is a worsening or new occurrence of adverse event (AE) during treatment compared to baseline. A summary of serious adverse events (SAE) and other nonserious AE are located in the Reported Adverse Events section. | Baseline through 72 hours after prasugrel loading dose |
| P2Y12 Reaction Units (PRU) of Clopidogrel Treated Participants at Baseline by Cytochrome P450 2C19 (CYP2C19)-Predicted Functional Groups - CYP2C19 Extensive Metabolizers (EM) and Reduced Metabolizers (RM) | CYP2C19 is a drug metabolizing enzyme. CYP2C19 Extensive metabolizers (EM) are individuals with two fully active / normal function CYP2C19 alleles (*1/*1, *1/*17). CYP2C19 Reduced metabolizers (RM) are individuals with at least one reduced-function CYP2C19 allele (*2/*2, *1/*2). Least Squares (LS) Mean values were controlled for CYP2C19 genetic group. | Baseline |
| P2Y12 Reaction Units (PRU) at 6 Hours Post-Prasugrel Loading Dose (LD) by Cytochrome P450 2C19 (CYP2C19)-Predicted Functional Groups - Extensive Metabolizers (EM) and Reduced Metabolizers (RM) | CYP2C19 is a drug metabolizing enzyme. CYP2C19 Extensive metabolizers (EM) are individuals with two fully active / normal function CYP2C19 alleles (*1/*1, *1/*17). CYP2C19 Reduced metabolizers (RM) are individuals with at least one reduced-function CYP2C19 allele (*2/*2, *1/*2). Least Squares (LS) Mean values were controlled for CYP2C19 genetic group. | 6 hours after prasugrel loading dose |
| India |
| 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. | Hyderabaad | 500 001 | India |
| 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 Delhi | 110 060 | India |
| Derived |
| Diodati JG, Saucedo JF, French JK, Fung AY, Cardillo TE, Henneges C, Effron MB, Fisher HN, Angiolillo DJ. Effect on platelet reactivity from a prasugrel loading dose after a clopidogrel loading dose compared with a prasugrel loading dose alone: Transferring From Clopidogrel Loading Dose to Prasugrel Loading Dose in Acute Coronary Syndrome Patients (TRIPLET): a randomized controlled trial. Circ Cardiovasc Interv. 2013 Oct 1;6(5):567-74. doi: 10.1161/CIRCINTERVENTIONS.112.000063. Epub 2013 Sep 24. |
| Physician Decision |
|
| Withdrawal by Subject |
|
| 600-mg Clopidogrel and 60-mg Prasugrel |
600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours. |
| BG002 | 600-mg Clopidogrel and 30-mg Prasugrel | 600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Qualifying Acute Coronary Syndrome (ACS) Event | Number | participants |
|
| OG001 | 600-mg Clopidogrel and 60-mg Prasugrel | 600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours. |
| OG002 | 600-mg Clopidogrel and 30-mg Prasugrel | 600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours. |
|
|
|
| Secondary | Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-Mediated Platelet Aggregation at Baseline, 2, 24 and 72 Hours After Prasugrel Loading Dose (LD) | ADP-induced P2Y12 receptor mediated platelet aggregation serves as a biomarker of platelet function. It is measured in P2Y12 Reaction Units (PRU) with lower PRU reflecting stronger inhibition of P2Y12 and reduced platelet aggregation. Least Squares (LS) Mean values were controlled for treatment, visit, treatment and visit interaction, and country. | All randomized participants who received prasugrel LD and had at least one evaluable PRU measurement after prasugrel LD. | Posted | Least Squares Mean | Standard Error | PRU | Baseline and 2 hours and 24 hours and 72 hours after prasugrel loading dose |
|
|
|
|
| Secondary | Mean Change From Baseline to 72 Hours in Laboratory Measurements - Hematocrit | All randomized participants who received prasugrel loading dose (LD) and had a Hematocrit measurement 72 hours after LD. | Posted | Mean | Standard Deviation | proportion of 1.0 | Baseline, 72 hours |
|
|
|
| Secondary | Mean Change From Baseline to 72 Hours in Laboratory Measurements - Hemoglobin | All randomized participants who received prasugrel loading dose (LD) and had a Hemoglobin measurement 72 hours after LD. | Posted | Mean | Standard Deviation | gram per deciliter (g/dL) | Baseline, 72 hours |
|
|
|
| Secondary | Percentage of Inhibition of Platelet Aggregation | Adenosine Diphosphate (ADP)-induced P2Y12 receptor mediated platelet aggregation serves as a biomarker of platelet function. It is measured in P2Y12 Reaction Units (PRU) with lower PRU reflecting stronger inhibition of P2Y12 and reduced platelet aggregation. The internal BASE standard is an independent measurement and serves as an estimate of the participant's baseline platelet aggregation independent of P2Y12 receptor inhibition. Percent Inhibition of Platelet Aggregation=(1-[PRU/BASE) x 100%, high numbers represent increased platelet inhibition. Least Squares (LS) Mean values were controlled for treatment, visit, treatment and visit interaction, and country.](streamdown:incomplete-link) | All randomized participants who received prasugrel loading dose (LD) and had at least one evaluable PRU measurement after prasugrel LD. | Posted | Least Squares Mean | Standard Error | percentage of inhibition | Baseline and 2 and 6 and 24 and 72 hours after loading dose |
|
|
|
|
| Secondary | Percentage of Poor Responders | Poor responders are those who had P2Y12 Reaction Units (PRU)≥ 240. | All randomized participants who received prasugrel loading dose (LD) and had at least one evaluable PRU measurement after prasugrel LD. | Posted | Number | percentage of participants | Baseline and 2 and 6 and 24 and 72 hours after loading dose |
|
|
|
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | TEAE is a worsening or new occurrence of adverse event (AE) during treatment compared to baseline. A summary of serious adverse events (SAE) and other nonserious AE are located in the Reported Adverse Events section. | Participants who received any treatment. | Posted | Number | participants | Baseline through 72 hours after prasugrel loading dose |
|
|
|
| Secondary | P2Y12 Reaction Units (PRU) of Clopidogrel Treated Participants at Baseline by Cytochrome P450 2C19 (CYP2C19)-Predicted Functional Groups - CYP2C19 Extensive Metabolizers (EM) and Reduced Metabolizers (RM) | CYP2C19 is a drug metabolizing enzyme. CYP2C19 Extensive metabolizers (EM) are individuals with two fully active / normal function CYP2C19 alleles (*1/*1, *1/*17). CYP2C19 Reduced metabolizers (RM) are individuals with at least one reduced-function CYP2C19 allele (*2/*2, *1/*2). Least Squares (LS) Mean values were controlled for CYP2C19 genetic group. | All randomized participants who were treated with Clopidogrel and had PRU measurement at Baseline and provided a DNA sample. | Posted | Least Squares Mean | Standard Error | PRU | Baseline |
|
|
|
|
| Secondary | P2Y12 Reaction Units (PRU) at 6 Hours Post-Prasugrel Loading Dose (LD) by Cytochrome P450 2C19 (CYP2C19)-Predicted Functional Groups - Extensive Metabolizers (EM) and Reduced Metabolizers (RM) | CYP2C19 is a drug metabolizing enzyme. CYP2C19 Extensive metabolizers (EM) are individuals with two fully active / normal function CYP2C19 alleles (*1/*1, *1/*17). CYP2C19 Reduced metabolizers (RM) are individuals with at least one reduced-function CYP2C19 allele (*2/*2, *1/*2). Least Squares (LS) Mean values were controlled for CYP2C19 genetic group. | All randomized participants who received prasugrel LD and had PRU measurements 6 hours after prasugrel LD and provided a DNA sample. | Posted | Least Squares Mean | Standard Error | PRU | 6 hours after prasugrel loading dose |
|
|
|
|
| 2 |
| 109 |
| 37 |
| 109 |
| EG001 | 600-mg Clopidogrel and 60-mg Prasugrel | 600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours. | 8 | 79 | 31 | 79 |
| EG002 | 600-mg Clopidogrel and 30-mg Prasugrel | 600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours. | 1 | 88 | 31 | 88 |
| Cardiac tamponade | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 14.1 | Systematic Assessment | This event resulted in death after the participant had discontinued the study (participant decision). |
|
| Cardiogenic shock | Cardiac disorders | MedDRA 14.1 | Systematic Assessment | This event resulted in death. |
|
| Coronary artery disease | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Coronary artery occlusion | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Femoral artery dissection | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Cardiac enzymes increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| High density lipoprotein decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 14.1 | 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 |
|
| 24 Hours after Prasugrel LD |
|
| 72 Hours after Prasugrel LD |
|
|
| Mixed Model Repeated Measures Analysis |
Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured. |
| 0.052 |
P-value is for Baseline. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant. |
| Mean Difference (Final Values) |
| 35.89 |
| 2-Sided |
| 95 |
| -0.29 |
| 72.06 |
| No |
| Superiority or Other |
| Mixed Model Repeated Measures Analysis | Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured. | 0.703 | P-value is for 2 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant. | Mean Difference (Final Values) | 9.45 | 2-Sided | 95 | -39.55 | 58.45 | No | Superiority or Other |
| Mixed Model Repeated Measures Analysis | Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured. | 0.823 | P-value is for 2 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant. | Mean Difference (Final Values) | 5.45 | 2-Sided | 95 | -42.53 | 53.44 | No | Superiority or Other |
| Mixed Model Repeated Measures Analysis | Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured. | 0.054 | P-value is for 24 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant. | Mean Difference (Final Values) | 28.69 | 2-Sided | 95 | -0.47 | 57.84 | No | Superiority or Other |
| Mixed Model Repeated Measures Analysis | Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured. | 0.436 | P-value is for 24 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant. | Mean Difference (Final Values) | 11.30 | 2-Sided | 95 | -17.29 | 39.90 | No | Superiority or Other |
| Mixed Model Repeated Measures Analysis | Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured. | 0.463 | P-value is for 72 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant. | Mean Difference (Final Values) | 8.87 | 2-Sided | 95 | -14.96 | 32.71 | No | Superiority or Other |
| Mixed Model Repeated Measures Analysis | Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured. | 0.777 | P-value is for 72 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant. | Mean Difference (Final Values) | -3.34 | 2-Sided | 95 | -26.62 | 19.94 | No | Superiority or Other |
|
| 6 Hours after Prasugrel LD |
|
| 24 Hours after Prasugrel LD |
|
| 72 Hours after Prasugrel LD |
|
|
| Mixed Model Repeated Measures Analysis |
Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured. |
| 0.278 |
P-value is for Baseline. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant. |
| Mean Difference (Final Values) |
| -5.23 |
| 2-Sided |
| 95 |
| -14.74 |
| 4.27 |
| No |
| Superiority or Other |
| Mixed Model Repeated Measures Analysis | Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured. | 0.749 | P-value is for 2 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant. | Mean Difference (Final Values) | -2.71 | 2-Sided | 95 | -19.44 | 14.02 | No | Superiority or Other |
| Mixed Model Repeated Measures Analysis | Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured. | 0.890 | P-value is for 2 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant. | Mean Difference (Final Values) | 1.15 | 2-Sided | 95 | -15.24 | 17.53 | No | Superiority or Other |
| Mixed Model Repeated Measures Analysis | Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured. | 0.223 | P-value is for 6 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant. | Mean Difference (Final Values) | -6.89 | 2-Sided | 95 | -18.02 | 4.24 | No | Superiority or Other |
| Mixed Model Repeated Measures Analysis | Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured. | 0.808 | P-value is for 6 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant. | Mean Difference (Final Values) | 1.33 | 2-Sided | 95 | -9.44 | 12.10 | No | Superiority or Other |
| Mixed Model Repeated Measures Analysis | Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured. | 0.049 | P-value is for 24 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant. | Mean Difference (Final Values) | -10.07 | 2-Sided | 95 | -20.11 | -0.04 | No | Superiority or Other |
| Mixed Model Repeated Measures Analysis | Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured. | 0.842 | P-value is for 24 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant. | Median Difference (Final Values) | -0.99 | 2-Sided | 95 | -10.85 | 8.86 | No | Superiority or Other |
| Mixed Model Repeated Measures Analysis | Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured. | 0.247 | P-value is for 72 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant. | Mean Difference (Final Values) | -5.03 | 2-Sided | 95 | -13.58 | 3.52 | No | Superiority or Other |
| Mixed Model Repeated Measures Analysis | Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured. | 0.942 | P-value is for 72 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant. | Mean Difference (Final Values) | 0.31 | 2-Sided | 95 | -8.09 | 8.71 | No | Superiority or Other |
|
| 6 Hours after Prasugrel LD |
|
| 24 Hours after Prasugrel LD |
|
| 72 Hours after Prasugrel LD |
|
|
A linear ANOVA model with PRU values of 6 hours Post-Prasugrel LD as response and treatment, CYP2C19 metabolizer status, interaction of treatment-by-CYP2C19 metabolizer status as fixed effects.
| ANOVA |
| 0.8913 |
| Mean Difference (Final Values) |
| -3.435 |
| 2-Sided |
| 95 |
| -53.23 |
| 46.37 |
| No |
| Superiority or Other |
| A linear ANOVA model with PRU values of 6 hours Post-Prasugrel LD as response and treatment, CYP2C19 metabolizer status, interaction of treatment-by-CYP2C19 metabolizer status as fixed effects. | ANOVA | 0.6229 | Mean Difference (Final Values) | 11.700 | 2-Sided | 95 | -35.43 | 58.83 | No | Superiority or Other |