A Phase 4 interventional study of prasugrel in Coronary Artery Disease, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-12-28.
Sponsored by University of Florida · Phase 4, Interventional, and Treatment
Prasugrel has shown to be superior to clopidogrel, in adjunct to aspirin, in preventing recurrent ischemic events. Prasugrel is approved in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) at a dosage of 60 mg loading dose (LD) followed by 10 mg/day. However, a delay in the onset of its antiplatelet effects in this particular setting has been consistently shown. administration of clopidogrel and ticagrelor crushed tablets has been tested and a faster and greater bioavailability compared to the whole tablets has been observed. However, if the administration of a crushed prasugrel LD may overcome the above limitation is still unknown and represents the aim of our study. The proposed investigation will have a prospective, randomized, design in which STEMI patients undergoing primary PCI will be randomized to receive two different formulation of prasugrel LD (60 mg whole tablets and 60 mg crushed tablets). Pharmacodynamic testing will be performed at several time points to test our study hypothesis that crushed LD regiment will achieve more prompt and enhanced platelet inhibitory effects.
Dual antiplatelet therapy consisting of aspirin and a P2Y12 receptor antagonist is the cornerstone of treatment for prevention of thrombotic events in patients with acute coronary syndromes (ACS). Prasugrel, a third generation thienopyridine, is an orally administered prodrug that needs single-step hepatic biotransformation into its active metabolite to irreversibly block the P2Y12 receptor. Prasugrel has shown to be superior to clopidogrel, in adjunct to aspirin, in preventing recurrent ischemic events. Prasugrel is approved in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) at a dosage of 60 mg loading dose (LD) followed by 10 mg/day. However, a delay in the onset of its antiplatelet effects in this particular setting has been consistently shown. The STEMI setting is characterized by conditions, such as impaired absorption and hepatic metabolism, patients either intubated, in shock or unable to swallow, which may affect the pharmacoki¬netic and pharmacodynamic effects of orally administered antiplatelet drugs. The administration of clopidogrel and ticagrelor crushed tablets has been tested and a faster and greater bioavailability compared to the whole tablets has been observed. However, if the administration of a crushed prasugrel LD may overcome the above limitation is still unknown and represents the aim of our study. The proposed investigation will have a prospective, randomized, design in which STEMI patients undergoing primary PCI will be randomized to receive two different formulation of prasugrel LD (60 mg whole tablets and 60 mg crushed tablets). Pharmacodynamic testing will be performed at several time points to test our study hypothesis that crushed LD regiment will achieve more prompt and enhanced platelet inhibitory effects. This study will provide insights on the pharmacodynamic effects of crushed prasugrel LD and will help clinicians choose the most appropriate treatment to avoid complications related to inadequate platelet inhibition in the early phase of patients with STEMI undergoing primary PCI.
5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.
This study's enrollment of 52 is below the median of 123 across 3,481 interventional studies indexed under Coronary Artery Disease.
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Exclusion criteria:
Pregnant females*
Prasugrel 60mg loading dose as crushed tablets
Drug: prasugrel
Prasugrel 60 mg loading dose as whole tablets
Drug: prasugrel
the effects of whole tablets versus crushed tablets will be compared
Also known as: Effient
P2Y12 Reaction Units (PRU)
The primary end-point of the study is the comparison in platelet reactivity expressed as PRU determined by VerifyNow P2Y12 between prasugrel 60 mg and crushed prasugrel 60 mg at 2 hours after LD administration
Time frame: 2 hrs
Platelet Reactivity Index (PRI)
The secondary end-point of the study is the comparison in platelet reactivity expressed as PRI determined by whole blood vasodilator-stimulated phosphoprotein (VASP) between prasugrel 60 mg and crushed prasugrel 60 mg at 2 hours after LD administration
Time frame: 2 hrs
Between October 15, 2014, and August 12, 2015, there were a total of 123 patients presenting with a STEMI at the University of Florida Health-Jacksonville, that were screened.
| Milestone | Prasugrel Crush | Prasugrel Tablets |
|---|---|---|
| Started | 26 | 26 |
| Completed | 26 | 26 |
| Not completed | 0 | 0 |
The primary end-point of the study is the comparison in platelet reactivity expressed as PRU determined by VerifyNow P2Y12 between prasugrel 60 mg and crushed prasugrel 60 mg at 2 hours after LD administration
| PRU | Prasugrel Crush | Prasugrel Tablets |
|---|---|---|
| P2Y12 Reaction Units (PRU) | 95 (55 to 135) | 164 (122 to 206) |
The secondary end-point of the study is the comparison in platelet reactivity expressed as PRI determined by whole blood vasodilator-stimulated phosphoprotein (VASP) between prasugrel 60 mg and crushed prasugrel 60 mg at 2 hours after LD administration
| PRI | Prasugrel Crush | Prasugrel Tablets |
|---|---|---|
| Platelet Reactivity Index (PRI) | 33 (20 to 46) | 61 (47 to 75) |
Collected over 3 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prasugrel Crush | — | 0/26 (0%) | 1/26 (3.8%) |
| Prasugrel Tablets | — | 0/26 (0%) | 0/26 (0%) |
| Event | Prasugrel Crush | Prasugrel Tablets |
|---|---|---|
| Minor bleedingRenal and urinary disorders | 1/26 | 0/26 |
Two patients in the whole tablets arm were excluded from the analysis because of missing data for the primary end point.
| Age, Continuous(years) | Prasugrel Crush | Prasugrel Tablets | Total |
|---|---|---|---|
| Mean | 57 ± 9 | 58 ± 10 | 58 ± 10 |
| Gender(Participants) | Prasugrel Crush | Prasugrel Tablets | Total |
|---|---|---|---|
| Female | 7 | 6 | 13 |
| Male | 19 | 18 | 37 |
| Race (NIH/OMB)(Participants) | Prasugrel Crush | Prasugrel Tablets | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 7 | 6 | 13 |
| White | 19 | 18 | 37 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
Plan to share: No
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Studies of the drug tested here: Prasugrel