- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02212028
Pharmacological Effects of Crushing Prasugrel in STEMI Patients
November 1, 2016 updated by: University of Florida
Pharmacodynamic and Pharmacokinetic Profiles of Prasugrel in Patients With ST Elevation Myocardial Infarction: A Randomized Comparison of Standard Versus Crushed Formulation
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.
Study Overview
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32209
- University of Florida
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Patients with ST-elevation myocardial infarction undergoing primary PCI
- Age between 18 and 75 years old
Exclusion criteria:
- Age >75 years
- Weight <60 Kg
- On treatment with a P2Y12 receptor antagonist (ticlopidine, clopidogrel, prasugrel, ticagrelor) in past 7 days
- Known allergies to aspirin or prasugrel
- Considered at high risk for bleeding
- History of ischemic or hemorrhagic stroke or transient ischemic attack
- On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban, apixaban)
- Treatment with IIb/IIIa glycoprotein inhibitors
- Fibrinolytics within 24 hours
- Known blood dyscrasia or bleeding diathesis
- Known platelet count <80x106/mL
- Known hemoglobin <10 g/dL
- Active bleeding
- Hemodynamic instability
- Known creatinine clearance <30 mL/minute
- Known severe hepatic dysfunction
Pregnant females*
- Women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Prasugrel crush
Prasugrel 60mg loading dose as crushed tablets
|
the effects of whole tablets versus crushed tablets will be compared
Other Names:
|
Active Comparator: Prasugrel tablets
Prasugrel 60 mg loading dose as whole tablets
|
the effects of whole tablets versus crushed tablets will be compared
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
P2Y12 Reaction Units (PRU)
Time Frame: 2 hrs
|
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
|
2 hrs
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Platelet Reactivity Index (PRI)
Time Frame: 2 hrs
|
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
|
2 hrs
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
August 6, 2014
First Submitted That Met QC Criteria
August 6, 2014
First Posted (Estimate)
August 8, 2014
Study Record Updates
Last Update Posted (Estimate)
December 28, 2016
Last Update Submitted That Met QC Criteria
November 1, 2016
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Myocardial Infarction
- Infarction
- Coronary Artery Disease
- ST Elevation Myocardial Infarction
- Platelet Aggregation Inhibitors
- Prasugrel Hydrochloride
Other Study ID Numbers
- Prasugrel-CRUSH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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