Coronary Artery Disease
Conditions
Keywords
coronary artery disease, percutaneous coronary revascularization, prasugrel therapy
Brief summary
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.
Interventions
DRUGPrasugrel
Prasugrel 10mg, 30mg, or 60mg
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with angiographically documented coronary artery disease. 2. Age between 18 to 74 years 3. On treatment with prasugrel 10mg/daily for at least 14 days.
Exclusion criteria
1. Blood dyscrasias or bleeding diathesis 2. Antiplatelet treatment with clopidogrel or ticlopidine 3. Recent antiplatelet treatment (\< 14 days) with a glycoprotein IIb/IIIa antagonist 4. Platelet count \<100x106/µL 5. Active bleeding or hemodynamic instability. 6. Unstable angina, acute or recent (\<14 days) myocardial infarction. 7. Serum creatinine \>2 mg/dL 8. Baseline ALT \>2.5 times the upper limit of normal 9. Oral anticoagulation with a coumarin derivative 10. History of stroke, TIA or intracranial bleeding 11. Weight \<60kg 12. Pregnant females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PRI Levels at 4 Hours | 4 hours after treatment |
Countries
United States
Participant flow
Recruitment details
Patients recuited at outpatient cardiology clinics
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Prasugrel 10mg Prasugrel was administered as one 10 mg tablet | 23 |
| Prasugrel 30mg Prasugrel was administered as three 10 mg tablets | 21 |
| Prasugrel 60mg Prasugrel was administered as six 10 mg tablets | 21 |
| Total | 65 |
Baseline characteristics
| Characteristic | Prasugrel 30mg | Prasugrel 60mg | Prasugrel 10mg | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 21 Participants | 23 Participants | 65 Participants |
| Age Continuous | 54 years STANDARD_DEVIATION 7 | 52 years STANDARD_DEVIATION 9 | 56 years STANDARD_DEVIATION 7 | 54 years STANDARD_DEVIATION 7 |
| Region of Enrollment United States | 21 participants | 21 participants | 23 participants | 65 participants |
| Sex: Female, Male Female | 8 Participants | 3 Participants | 7 Participants | 18 Participants |
| Sex: Female, Male Male | 13 Participants | 18 Participants | 16 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 65 |
| serious Total, serious adverse events | 0 / 65 |
Outcome results
Primary
PRI Levels at 4 Hours
Time frame: 4 hours after treatment
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prasugrel 10mg | PRI Levels at 4 Hours | 28.8 percentage of platelet reactivity | Standard Error 2.8 |
| Prasugrel 30mg | PRI Levels at 4 Hours | 11 percentage of platelet reactivity | Standard Error 2.9 |
| Prasugrel 60mg | PRI Levels at 4 Hours | 2.8 percentage of platelet reactivity | Standard Error 2.7 |