NCT01835353

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

September 23, 2013

Status Verified

September 1, 2013

Enrollment Period

1.1 years

First QC Date

April 15, 2013

Last Update Submit

September 20, 2013

Conditions

Platelet Reactivity

Keywords

prasugrelST elevation myocardial infarction

Outcome Measures

Primary Outcomes (1)

  • Platelet reactivity in Platelet reactivity units (PRU) at Hour 2

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

    2 hours

Secondary Outcomes (7)

  • Platelet reactivity in platelet reactivity units (PRU)at hour 1

    1 hour

  • Platelet reactivity in platelet reactivity units (PRU)at hour 0.5

    0.5 hours

  • Platelet reactivity in platelet reactivity units (PRU)at hour 4

    4 hours

  • High platelet reactivity rate (208 PRU threshold) at 0.5 hour

    0.5 hour

  • High platelet reactivity rate (208 PRU threshold) at 1 hour

    1 hour

  • +2 more secondary outcomes

Study Arms (2)

Prasugrel 100mg loading dose

EXPERIMENTAL

Prasugrel 100mg loading dose

Drug: Prasugrel 100mg loading dose

Prasugrel 60mg loading dose

ACTIVE COMPARATOR
Drug: Prasugrel 60mg loading dose

Interventions

Prasugrel 100mg loading doseDRUG
Prasugrel 100mg loading dose
Prasugrel 60mg loading doseDRUG

Prasugrel 60mg loading dose

Prasugrel 60mg loading dose

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dimitrios Alexopoulos

Pátrai, Achaia, 26500, Greece

Location

Related Publications (1)

  • 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.

    PMID: 24668226DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 15, 2013

First Posted

April 18, 2013

Study Start

June 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

September 23, 2013

Record last verified: 2013-09

Locations

GR(1)