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High (100mg) Versus Standard (60mg) Loading Dose of Prasugrel in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)

NCT ID: NCT01835353

Last Updated: 2013-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-07-31

Brief Summary

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This is a prospective, multi-center, non-randomized, controlled study in 2 sequential groups of P2Y12 inhibitor-naive consecutive STEMI patients undergoing primary PCI. Following aspirin 325 mg LD, patients will receive 60 mg or 100 mg of prasugrel, respectively. Platelet reactivity (PR)will be assessed at Hour 0 (before prasugrel's administration immediately prior to PCI) and at Hours 0.5, 1, 2, 4 thereafter. Platelet function testing (in PRU) will be performed with the VerifyNow (Accumetrics Inc., San Diego, CA, USA) P2Y12 function assay.

Detailed Description

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Conditions

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Platelet Reactivity

Keywords

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prasugrel ST elevation myocardial infarction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Prasugrel 100mg loading dose

Prasugrel 100mg loading dose

Group Type EXPERIMENTAL

Prasugrel 100mg loading dose

Intervention Type DRUG

Prasugrel 60mg loading dose

Group Type ACTIVE_COMPARATOR

Prasugrel 60mg loading dose

Intervention Type DRUG

Prasugrel 60mg loading dose

Interventions

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Prasugrel 100mg loading dose

Intervention Type DRUG

Prasugrel 60mg loading dose

Prasugrel 60mg loading dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ST elevation myocardial infarction
* Pain onset \<12 hours
* Age \>18 and \<75 years
* Written informed consent

Exclusion Criteria

* history of stroke/transient ischemic attack
* oral anticoagulation
* hemodynamic instability
* platelet count \<100000/μL
* hematocrit \<30%
* creatinine clearance \<30 ml/min
* severe hepatic dysfunction
* active bleeding
* weight \<60 Kg
* periprocedural IIb/IIIa inhibitor administration
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Patras

OTHER

Sponsor Role lead

Responsible Party

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Dimitrios Alexopoulos

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dimitrios Alexopoulos

Pátrai, Achaia, Greece

Site Status

Countries

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Greece

References

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Alexopoulos D, Makris G, Xanthopoulou I, Patsilinakos S, Deftereos S, Gkizas V, Perperis A, Karanikas S, Angelidis C, Tsigkas G, Koutsogiannis N, Hahalis G, Davlouros P. Onset of antiplatelet action with high (100 mg) versus standard (60 mg) loading dose of prasugrel in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention: pharmacodynamic study. Circ Cardiovasc Interv. 2014 Apr;7(2):233-9. doi: 10.1161/CIRCINTERVENTIONS.113.001118. Epub 2014 Mar 25.

Reference Type DERIVED
PMID: 24668226 (View on PubMed)

Other Identifiers

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PATRASCARDIOLOGY-13

Identifier Type: -

Identifier Source: org_study_id