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The primary objective of the study is to describe the cumulative proportion of participants who return to baseline platelet P2Y12 receptor function over time (up to 12 days post last maintenance dose) following discontinuation of prasugrel 10 mg daily x 7 days assessed by Accumetrics VerifyNow P2Y12 reaction units (PRU) and described by Kaplan Meier curves. The primary analysis is descriptive and is intended to provide information relating to the return of baseline platelet function following discontinuation of maintenance therapy with either prasugrel or clopidogrel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prasugrel | Experimental | Prasugrel 10mg administered for 7 days followed by a Washout Period up to 12 days. |
|
| Clopidogrel | Active Comparator | Clopidogrel 75mg administered for 7 days followed by a 12 day Washout Period up to 12 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prasugrel | Drug | Prasugrel 10mg tablet administered once daily for 7 days. After a 1-day to 14-day screening period, participants will receive active treatment with either prasugrel or clopidogrel for 7 days. If a participant has not missed more than 1 dose of study medication and is unable to attend Visit 3 (Washout Day 1) the day after the 7th day of study medication, the participant may take up to an additional 3 days of study medication and proceed to Visit 3 the day after the last dose. Active treatment will be followed by a 1-day to 12-day Washout Period depending on the time to reach both of the exit criteria. |
| Measure | Description | Time Frame |
|---|---|---|
| The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Primary Definition of Return to Baseline | On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participant met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to 20%. The results are expressed as cumulative percentage of participants. | up to 12 days after last dose |
| The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Secondary Definition of Return to Baseline | On the first day of the Washout Period (visit 3), the blood draw for platelet function testing was obtained 24 hours (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participant met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to 20%. | up to 12 days after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on Primary Definition of Return to Baseline Using the Primary Population | On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/-6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participants met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%. |
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Inclusion Criteria:
Male or female subjects >/= 18 years and <75 years of age
Weight >/= 60 kg
On aspirin therapy (81 mg to 325 mg daily) at the time of screening and able to maintain a consistent aspirin dosing regimen from the baseline visit through the final study visit
Subjects who do not have contraindications for a thienopyridine (ie, prasugrel, clopidogrel or ticlopidine), and have a history of stable atherosclerosis represented by Coronary Artery disease, defined as any of the following:
Female subjects who meet one of the following:
Subjects with a competent mental condition to provide written informed consent before entering the study.
Exclusion Criteria:
Any other formal indication for the use of a thienopyridine.
Subjects with a history of refractory ventricular arrhythmias.
Subjects with a history of an implantable defibrillator device.
Subjects with a history or evidence of congestive heart failure (New York Heart Association [NYHA] Class III or above) within 6 months prior to screening.
Subjects with significant hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) at either the time of screening or baseline assessment.
Bleeding Risk Exclusion Criteria:
Prior/Concomitant Therapy Exclusion Criteria:
General Exclusion Criteria:
Subjects who have had an angiogram \
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Clinic | La Jolla | California | 92037 | United States | ||
| University of Florida Health Science Center Shands Jacksonville |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22698488 | Derived | Price MJ, Walder JS, Baker BA, Heiselman DE, Jakubowski JA, Logan DK, Winters KJ, Li W, Angiolillo DJ. Recovery of platelet function after discontinuation of prasugrel or clopidogrel maintenance dosing in aspirin-treated patients with stable coronary disease: the recovery trial. J Am Coll Cardiol. 2012 Jun 19;59(25):2338-43. doi: 10.1016/j.jacc.2012.02.042. |
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The Overall Study Period included a 1-day to 14-day Screening Period, a 7-day Active Treatment Period, and a Washout Period of up to 12 days. Following the 1-day to 14-day Screening Period, eligible participants were randomized in a 1:1 ratio to either prasugrel or clopidogrel at Visit 2 (the first day of the Active Treatment Period).
Participants were recruited at 4 sites in the US from 23 February 2010 to 24 May 2010 and 56 participants were randomized into the study. The study population consisted of male and female aspirin-treated participants with stable coronary artery disease, 18 to 75 years of age.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prasugrel | Prasugrel 10mg tablet administered once daily for 7 days followed by a Washout Period up to 12 days. |
| FG001 | Clopidogrel | Clopidogrel 75 mg tablet administered once daily for 7 days followed by Washout Period up to 12 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prasugrel | Prasugrel 10mg tablet administered once daily for 7 days followed by a Washout Period up to 12 days. |
| BG001 | Clopidogrel | Clopidogrel 75 mg tablet administered once daily for 7 days followed by Washout Period up to 12 days. |
| 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 | The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Primary Definition of Return to Baseline | On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participant met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to 20%. The results are expressed as cumulative percentage of participants. | Participants in Primary Population defined as Baseline PRU-PRU less than or equal to 60 units (R-to-B). Primary Population included participants who entered Washout Period and had platelet function data at both baseline and Washout Period Day 1. | Posted | Number | cumulative percentage of participants | up to 12 days after last dose |
|
Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after participant signed informed consent and up to 14 days after last dose of study drug were recorded
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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 10mg tablet administered once daily for 7 days followed by a Washout Period up to 12 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| eyelid oedema | Ear and labyrinth disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Baker | Daiichi Sankyo, Inc. | 973-944-2712 | bbaker@dsi.com |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular 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 | Clopidogrel 75 mg tablet administered once daily for 7 days. After a 1-day to 14-day screening period, participants will receive active treatment with either prasugrel or clopidogrel for 7 days. If a participant has not missed more than 1 dose of study medication and is unable to attend Visit 3 (Washout Day 1) the day after the 7th day of study medication, the participant may take up to an additional 3 days of study medication and proceed to Visit 3 the day after the last dose. Active treatment will be followed by a 1-day to 12-day Washout Period depending on the time to reach both of the exit criteria. |
|
|
| up to 12 days after last dose |
| Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on Secondary Definition of Return to Baseline Using the Primary Population | On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/-6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participant met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%. | up to 12 days after last dose |
| Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on the Primary Definition of Return to Baseline Using the Responder Population | On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/-6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participant met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%. | up to 12 days after last dose |
| Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on the Secondary Definition of Return to Baseline Using the Responder Population | On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hour (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participant met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to (<=) 20%. | up to 12 days after the last dose |
| Percentage of Inhibition of Platelet Aggregation on Washout Day 1 | Inhibition of platelet aggregation was assessed by Accumetrics VerifyNow® P2Y12 reaction units (PRU). On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hour (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participant met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to 20%. | Washout Day 1 |
| Time to Return to Baseline PRU for the Primary Population Using the Primary Definition of Return to Baseline in Relation to the Inhibition of Platelet Aggregation 24 Hours Following the Last Maintenance Dose | Time to return to baseline PRU (<= 60 units of baseline) dependent upon baseline PRU and platelet % inhibition on Washout Period Day 1 but independent of treatment. The following regression model was derived for predicting number of days to return to baseline PRU where PI(1) represents platelet percentage inhibition on Washout Day 1. Number days to return to baseline PRU derived from: Number days to return to baseline PRU=-3.350+0.079*PI(1)+0.014*baseline PRU. The predicted number of days to return to baseline based on device-derived platelet percentage inhibition is reported for each treatment group. | up to 12 days after the last dose |
| Jacksonville |
| Florida |
| 32209 |
| United States |
| Medpace Clinical Pharmacology Unit | Cincinnati | Ohio | 45212 | United States |
| Black Hills Clinical Research Center | Rapid City | South Dakota | 57701 | United States |
| Withdrawal by Subject |
|
| BG002 | 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 |
|
| weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | cm |
|
| Ethnicity | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Smoking Status | Number | participants |
|
| Alcohol Use | Number | participants |
|
| Diabetes status | Number | participants |
|
| Prasugrel |
Prasugrel 10mg tablet administered once daily for 7 days followed by a Washout period up to 12 days. |
| OG001 | Clopidogrel | Clopidogrel 75 mg tablet administered once daily for 7 days followed by Washout period up to 12 days. |
|
|
| Primary | The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Secondary Definition of Return to Baseline | On the first day of the Washout Period (visit 3), the blood draw for platelet function testing was obtained 24 hours (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participant met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to 20%. | Participants in Primary Population using secondary definition of return to baseline. Primary Population included participants who entered the Washout Period and had platelet function data at both baseline and Washout Period Day 1. Secondary definition of return to baseline was (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%. | Posted | Number | cumulative percentage of participants | up to 12 days after last dose |
|
|
|
| Secondary | Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on Primary Definition of Return to Baseline Using the Primary Population | On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/-6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participants met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%. | Participants in Primary Population using primary definition of return to baseline. Primary population included participants who entered the Washout Period and had platelet function data at both baseline and Washout Period Day 1. Primary definition of return to baseline was (Baseline PRU-PRU) less than or equal to 60 units. | Posted | Number | days | up to 12 days after last dose |
|
|
|
| Secondary | Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on Secondary Definition of Return to Baseline Using the Primary Population | On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/-6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participant met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%. | Participants in Primary Population using secondary definition of return to baseline. Primary Population included participants who entered Washout Period and had platelet function data at both baseline and Washout Period Day 1. Secondary definition of return to baseline was (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%. | Posted | Number | days | up to 12 days after last dose |
|
|
|
| Secondary | Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on the Primary Definition of Return to Baseline Using the Responder Population | On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/-6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participant met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%. | Participants in Responder Population using primary definition of R-to-B. Primary Population included participants who entered Washout Period and had platelet function data at baseline and Washout Day 1. Responder Population was Primary Population excluding poor pharmacodynamic responders. Primary definition of R-to-B was (Baseline PRU-PRU) less than or equal to 60 units. | Posted | Number | days | up to 12 days after last dose |
|
|
|
| Secondary | Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on the Secondary Definition of Return to Baseline Using the Responder Population | On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hour (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participant met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to (<=) 20%. | Participants in Responder Population using secondary definition of R-to-B. Primary Population included participants who entered Washout Period and had platelet function data at both baseline and Washout Period Day 1. Responder Population was Primary Population excluding poor pharmacodynamic responders. Secondary definition of R-to-B was (Baseline PRU-PRU)/ (Baseline PRU) <= 20%. | Posted | Number | days | up to 12 days after the last dose |
|
|
|
| Secondary | Percentage of Inhibition of Platelet Aggregation on Washout Day 1 | Inhibition of platelet aggregation was assessed by Accumetrics VerifyNow® P2Y12 reaction units (PRU). On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hour (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participant met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to 20%. | Participants in the Primary Population. The Primary Population included participants who entered the Washout Period and had platelet function testing data at both baseline (Visit 2) and Washout Period Day 1 (Visit 3). | Posted | Mean | Standard Deviation | percentage | Washout Day 1 |
|
|
|
| Secondary | Time to Return to Baseline PRU for the Primary Population Using the Primary Definition of Return to Baseline in Relation to the Inhibition of Platelet Aggregation 24 Hours Following the Last Maintenance Dose | Time to return to baseline PRU (<= 60 units of baseline) dependent upon baseline PRU and platelet % inhibition on Washout Period Day 1 but independent of treatment. The following regression model was derived for predicting number of days to return to baseline PRU where PI(1) represents platelet percentage inhibition on Washout Day 1. Number days to return to baseline PRU derived from: Number days to return to baseline PRU=-3.350+0.079*PI(1)+0.014*baseline PRU. The predicted number of days to return to baseline based on device-derived platelet percentage inhibition is reported for each treatment group. | Participants in the Primary Population. The Primary Population included participants who entered the Washout Period and had platelet function testing data at both baseline (Visit 2) and Washout Period Day 1 (Visit 3). The primary definition of return to baseline was (Baseline PRU-PRU) less than or equal to 60 units. | Posted | Number | days | up to 12 days after the last dose |
|
|
|
| 0 |
| 29 |
| 12 |
| 29 |
| EG001 | Clopidogrel | Clopidogrel 75 mg tablet administered once daily for 7 days followed by Washout Period up to 12 days. | 0 | 27 | 9 | 27 |
| Adominal discomfort | Gastrointestinal disorders | MedDRA Version 13.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 13.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 13.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA Version 13.0 | Systematic Assessment |
|
| nasopharyngitis | Infections and infestations | MedDRA Version 13.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 13.0 | Systematic Assessment |
|
| viral infection | Infections and infestations | MedDRA Version 13.0 | Systematic Assessment |
|
| diabetes mellitus | Metabolism and nutrition disorders | MedDRA Version 13.0 | Systematic Assessment |
|
| dizziness | Nervous system disorders | MedDRA Version 13.0 | Systematic Assessment |
|
| headache | Nervous system disorders | MedDRA Version 13.0 | Systematic Assessment |
|
| insomnia | Psychiatric disorders | MedDRA Version 13.0 | Systematic Assessment |
|
| epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Systematic Assessment |
|
| ecchymosis | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Systematic Assessment |
|
| increased tendency to bruise | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Systematic Assessment |
|
| Adominal pain upper | Gastrointestinal disorders | MedDRA Version 13.0 | Systematic Assessment |
|
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| 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 |
| returned to baseline PRU by washout day 5 |
|
| returned to baseline PRU by washout day 6 |
|
| returned to baseline PRU by washout day 7 |
|
| returned to baseline PRU by washout day 9 |
|
| Washout day 90% returned to baseline PRU |
|
| Washout day 90% returned to baseline PRU |
|
| Washout day 90% returned to baseline PRU |
|
| Washout day 90% returned to baseline PRU |
|