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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)

Primary Purpose

Platelet Reactivity

Status
Completed
Phase
Phase 3
Locations
Greece
Study Type
Interventional
Intervention
Prasugrel 100mg loading dose
Prasugrel 60mg loading dose
Sponsored by
University of Patras
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Platelet Reactivity focused on measuring prasugrel, ST elevation myocardial infarction

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dimitrios Alexopoulos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prasugrel 100mg loading dose

Prasugrel 60mg loading dose

Arm Description

Prasugrel 100mg loading dose

Outcomes

Primary Outcome Measures

Platelet reactivity in Platelet reactivity units (PRU) at Hour 2
Platelet reactivity in Platelet reactivity units (PRU) 2 hours post randomization

Secondary Outcome Measures

Platelet reactivity in platelet reactivity units (PRU)at hour 1
Platelet reactivity in platelet reactivity units (PRU)1 hour post randomization
Platelet reactivity in platelet reactivity units (PRU)at hour 0.5
Platelet reactivity in platelet reactivity units (PRU)0.5 hour post randomization
Platelet reactivity in platelet reactivity units (PRU)at hour 4
Platelet reactivity in platelet reactivity units (PRU)4 hours post randomization
High platelet reactivity rate (208 PRU threshold) at 0.5 hour
High platelet reactivity rate (208 PRU threshold) 0.5 hour post randomization
High platelet reactivity rate (208 PRU threshold) at 1 hour
High platelet reactivity rate (208 PRU threshold) 1 hour post randomization
High platelet reactivity rate (208 PRU threshold) at 2 hour
High platelet reactivity rate (208 PRU threshold) 2 hours post randomization
High platelet reactivity rate (208 PRU threshold) at 4 hour
High platelet reactivity rate (208 PRU threshold) 4 hours post randomization

Full Information

First Posted
April 15, 2013
Last Updated
September 20, 2013
Sponsor
University of Patras
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1. Study Identification

Unique Protocol Identification Number
NCT01835353
Brief Title
High (100mg) Versus Standard (60mg) Loading Dose of Prasugrel in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)
Official Title
High (100mg) Versus Standard (60mg) Loading Dose of Prasugrel in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Patras

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Platelet Reactivity
Keywords
prasugrel, ST elevation myocardial infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prasugrel 100mg loading dose
Arm Type
Experimental
Arm Description
Prasugrel 100mg loading dose
Arm Title
Prasugrel 60mg loading dose
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Prasugrel 100mg loading dose
Intervention Type
Drug
Intervention Name(s)
Prasugrel 60mg loading dose
Intervention Description
Prasugrel 60mg loading dose
Primary Outcome Measure Information:
Title
Platelet reactivity in Platelet reactivity units (PRU) at Hour 2
Description
Platelet reactivity in Platelet reactivity units (PRU) 2 hours post randomization
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Platelet reactivity in platelet reactivity units (PRU)at hour 1
Description
Platelet reactivity in platelet reactivity units (PRU)1 hour post randomization
Time Frame
1 hour
Title
Platelet reactivity in platelet reactivity units (PRU)at hour 0.5
Description
Platelet reactivity in platelet reactivity units (PRU)0.5 hour post randomization
Time Frame
0.5 hours
Title
Platelet reactivity in platelet reactivity units (PRU)at hour 4
Description
Platelet reactivity in platelet reactivity units (PRU)4 hours post randomization
Time Frame
4 hours
Title
High platelet reactivity rate (208 PRU threshold) at 0.5 hour
Description
High platelet reactivity rate (208 PRU threshold) 0.5 hour post randomization
Time Frame
0.5 hour
Title
High platelet reactivity rate (208 PRU threshold) at 1 hour
Description
High platelet reactivity rate (208 PRU threshold) 1 hour post randomization
Time Frame
1 hour
Title
High platelet reactivity rate (208 PRU threshold) at 2 hour
Description
High platelet reactivity rate (208 PRU threshold) 2 hours post randomization
Time Frame
2 hours
Title
High platelet reactivity rate (208 PRU threshold) at 4 hour
Description
High platelet reactivity rate (208 PRU threshold) 4 hours post randomization
Time Frame
4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Dimitrios Alexopoulos
City
Patras
State/Province
Achaia
ZIP/Postal Code
26500
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
24668226
Citation
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.
Results Reference
derived

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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)

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