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Trial record 85 of 509 for:    ASPIRIN AND P2

Pharmacological Effects of Crushing Prasugrel in STEMI Patients

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ClinicalTrials.gov Identifier: NCT02212028
Recruitment Status : Completed
First Posted : August 8, 2014
Results First Posted : December 28, 2016
Last Update Posted : December 28, 2016
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: prasugrel Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacodynamic and Pharmacokinetic Profiles of Prasugrel in Patients With ST Elevation Myocardial Infarction: A Randomized Comparison of Standard Versus Crushed Formulation
Study Start Date : October 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Prasugrel

Arm Intervention/treatment
Experimental: Prasugrel crush
Prasugrel 60mg loading dose as crushed tablets
Drug: prasugrel
the effects of whole tablets versus crushed tablets will be compared
Other Name: Effient

Active Comparator: Prasugrel tablets
Prasugrel 60 mg loading dose as whole tablets
Drug: prasugrel
the effects of whole tablets versus crushed tablets will be compared
Other Name: Effient




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212028


Locations
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United States, Florida
University of Florida
Jacksonville, Florida, United States, 32209
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Dominick Angiolillo University of Florida

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02212028     History of Changes
Other Study ID Numbers: Prasugrel-CRUSH
First Posted: August 8, 2014    Key Record Dates
Results First Posted: December 28, 2016
Last Update Posted: December 28, 2016
Last Verified: August 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Florida:
ST-elevation myocardial infarction
prasugrel
pharmacodynamic
pharmacokinetic
Additional relevant MeSH terms:
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Coronary Artery Disease
ST Elevation Myocardial Infarction
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Myocardial Infarction
Prasugrel Hydrochloride
Platelet Aggregation Inhibitors