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A higher degree of platelet inhibition remains the goal of peri-interventional and long-term anti-thrombotic therapy in patients with coronary artery disease. In clinical practice, patients undergoing percutaneous coronary intervention with stent implantation who are already on clopidogrel therapy get re-loaded with clopidogrel. This is based on prior observations showing that higher inhibition of platelet aggregation may be achieved by giving a loading dose of clopidogrel in patients with coronary artery disease while on chronic clopidogrel therapy. However, to date it is unknown if greater inhibition of platelet aggregation can be achieved by adding a prasugrel loading dose in patients on chronic prasugrel therapy. Therefore, understanding the pharmacodynamic implications of a prasugrel re-load strategy in patients on already on chronic prasugrel therapy will be useful.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prasugrel 60mg | Active Comparator | Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel |
|
| Prasugrel 30mg | Active Comparator | Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel |
|
| Prasugrel 10mg | No Intervention | Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prasugrel | Drug | Prasugrel 10mg, 30mg, or 60mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| PRI Levels at 4 Hours | 4 hours after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dominick Angiolillo, MD, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Jacksonville | Florida | 32209 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22554598 | Result | Tello-Montoliu A, Tomasello SD, Ferreiro JL, Ueno M, Seecheran N, Desai B, Kodali M, Charlton RK, Box LC, Zenni MM, Guzman LA, Bass TA, Angiolillo DJ. Pharmacodynamic effects of prasugrel dosing regimens in patients on maintenance prasugrel therapy: results of a prospective randomized study. J Am Coll Cardiol. 2012 May 8;59(19):1681-7. doi: 10.1016/j.jacc.2011.12.039. |
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Seventy-seven patients on maintenance prasugrel therapy were screened. Of these, 11 patients refused to participate in the study and one patient was excluded due to a positive pregnancy test. Thus, a total of 65 patients were randomized.
Patients recuited at outpatient cardiology clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | Prasugrel 10mg | Prasugrel was administered as one 10 mg tablet |
| FG001 | Prasugrel 30mg | Prasugrel was administered as three 10 mg tablet |
| FG002 | Prasugrel 60mg | Prasugrel was administered as six 10 mg tablet |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prasugrel 10mg | Prasugrel was administered as one 10 mg tablet |
| BG001 | Prasugrel 30mg | Prasugrel was administered as three 10 mg tablets |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | PRI Levels at 4 Hours | A total of 65 patients were randomized. One patient assigned to the 10mg prasugrel group was withdrawn after randomization due to anemia identified after baseline blood sampling. Finally, 64 patients [10 mg (n=22), 30 mg (n=21) and 60 mg (n=21)] completed all time periods of the study. | Posted | Mean | Standard Error | percentage of platelet reactivity | 4 hours after treatment |
|
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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 | All Study Participants | All participants who received prasugrel |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dominick Angiolillo | University of Florida | 904-244-3933 | dominick.angiolillo@jax.ufl.edu |
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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 |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
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| BG002 | Prasugrel 60mg | Prasugrel was administered as six 10 mg tablets |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Prasugrel 60mg |
Prasugrel was administered as six 10 mg tablets |
|
|
| 0 |
| 65 |
| 0 |
| 65 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |