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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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ClinicalTrials.gov Identifier: NCT01835353
Recruitment Status : Completed
First Posted : April 18, 2013
Last Update Posted : September 23, 2013
Sponsor:
Information provided by (Responsible Party):
Dimitrios Alexopoulos, University of Patras

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.

Condition or disease Intervention/treatment Phase
Platelet Reactivity Drug: Prasugrel 100mg loading dose Drug: Prasugrel 60mg loading dose Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Prasugrel

Arm Intervention/treatment
Experimental: Prasugrel 100mg loading dose
Prasugrel 100mg loading dose
Drug: Prasugrel 100mg loading dose
Active Comparator: Prasugrel 60mg loading dose Drug: Prasugrel 60mg loading dose
Prasugrel 60mg loading dose




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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. 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

  5. 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

  6. 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

  7. 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



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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01835353


Locations
Greece
Dimitrios Alexopoulos
Patras, Achaia, Greece, 26500
Sponsors and Collaborators
University of Patras

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dimitrios Alexopoulos, Professor, University of Patras
ClinicalTrials.gov Identifier: NCT01835353     History of Changes
Other Study ID Numbers: PATRASCARDIOLOGY-13
First Posted: April 18, 2013    Key Record Dates
Last Update Posted: September 23, 2013
Last Verified: September 2013

Keywords provided by Dimitrios Alexopoulos, University of Patras:
prasugrel
ST elevation myocardial infarction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Prasugrel Hydrochloride
Platelet Aggregation Inhibitors