Pharmacological Effects of Crushing Prasugrel in STEMI Patients

NCT02212028 | Completed Phase 4 Results DMC

• 1 other identifier: Prasugrel-CRUSH
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

ST-elevation myocardial infarction; prasugrel; pharmacodynamic; pharmacokinetic

Outcome Measures

Primary Outcomes (1)

• 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

  2 hrs

Secondary Outcomes (1)

• Platelet Reactivity Index (PRI)

  2 hrs

Study Arms (2)

Prasugrel crush

EXPERIMENTAL

Prasugrel 60mg loading dose as crushed tablets

Drug: prasugrel

Prasugrel tablets

ACTIVE COMPARATOR

Prasugrel 60 mg loading dose as whole tablets

Drug: prasugrel

Interventions

prasugrel DRUG

the effects of whole tablets versus crushed tablets will be compared

Also known as: Effient

Prasugrel crush; Prasugrel tablets

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with ST-elevation myocardial infarction undergoing primary PCI
• Age between 18 and 75 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Jacksonville, Florida, 32209, United States

Location

Related Publications (1)

• Rollini F, Franchi F, Hu J, Kureti M, Aggarwal N, Durairaj A, Park Y, Seawell M, Cox-Alomar P, Zenni MM, Guzman LA, Suryadevara S, Antoun P, Bass TA, Angiolillo DJ. Crushed Prasugrel Tablets in Patients With STEMI Undergoing Primary Percutaneous Coronary Intervention: The CRUSH Study. J Am Coll Cardiol. 2016 May 3;67(17):1994-2004. doi: 10.1016/j.jacc.2016.02.045. Epub 2016 Mar 21.

  PMID: 27012781 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; ST Elevation Myocardial Infarction

Interventions

Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dominick J. Angiolillo, MD, PhD
• Organization: University of Florida College of Medicine-Jacksonville

dominick.angiolillo@jax.ufl.edu

+1-904-244-3933

Study Officials

• Dominick Angiolillo

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2014
• First Posted: August 8, 2014
• Study Start: October 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 28, 2016
• Results First Posted: December 28, 2016

Record last verified: 2015-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)