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

September 20, 2013 updated by: Dimitrios Alexopoulos, University of Patras
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 3

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

  • Greece
    • Achaia
      • Patras, Achaia, Greece, 26500
        • Dimitrios Alexopoulos

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 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prasugrel 100mg loading dose
Drug: Prasugrel 100mg loading dose
Active Comparator: Prasugrel 60mg loading dose
Drug: Prasugrel 60mg loading dose
Prasugrel 60mg loading dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet reactivity in Platelet reactivity units (PRU) at Hour 2
Time Frame: 2 hours
Platelet reactivity in Platelet reactivity units (PRU) 2 hours post randomization
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet reactivity in platelet reactivity units (PRU)at hour 1
Time Frame: 1 hour
Platelet reactivity in platelet reactivity units (PRU)1 hour post randomization
1 hour
Platelet reactivity in platelet reactivity units (PRU)at hour 0.5
Time Frame: 0.5 hours
Platelet reactivity in platelet reactivity units (PRU)0.5 hour post randomization
0.5 hours
Platelet reactivity in platelet reactivity units (PRU)at hour 4
Time Frame: 4 hours
Platelet reactivity in platelet reactivity units (PRU)4 hours post randomization
4 hours
High platelet reactivity rate (208 PRU threshold) at 0.5 hour
Time Frame: 0.5 hour
High platelet reactivity rate (208 PRU threshold) 0.5 hour post randomization
0.5 hour
High platelet reactivity rate (208 PRU threshold) at 1 hour
Time Frame: 1 hour
High platelet reactivity rate (208 PRU threshold) 1 hour post randomization
1 hour
High platelet reactivity rate (208 PRU threshold) at 2 hour
Time Frame: 2 hours
High platelet reactivity rate (208 PRU threshold) 2 hours post randomization
2 hours
High platelet reactivity rate (208 PRU threshold) at 4 hour
Time Frame: 4 hours
High platelet reactivity rate (208 PRU threshold) 4 hours post randomization
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Patras

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.

General Publications

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

June 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

April 15, 2013

First Submitted That Met QC Criteria

April 15, 2013

First Posted (Estimate)

April 18, 2013

Study Record Updates

Last Update Posted (Estimate)

September 23, 2013

Last Update Submitted That Met QC Criteria

September 20, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PATRASCARDIOLOGY-13

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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