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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dimitrios Alexopoulos, University of Patras
ClinicalTrials.gov Identifier:
NCT01835353
First received: April 15, 2013
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Platelet Reactivity
Drug: Prasugrel 100mg loading dose
Drug: Prasugrel 60mg loading dose
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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)

Resource links provided by NLM:


Further study details as provided by University of Patras:

Primary Outcome Measures:
  • Platelet reactivity in Platelet reactivity units (PRU) at Hour 2 [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Platelet reactivity in Platelet reactivity units (PRU) 2 hours post randomization


Secondary Outcome Measures:
  • Platelet reactivity in platelet reactivity units (PRU)at hour 1 [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Platelet reactivity in platelet reactivity units (PRU)1 hour post randomization

  • Platelet reactivity in platelet reactivity units (PRU)at hour 0.5 [ Time Frame: 0.5 hours ] [ Designated as safety issue: No ]
    Platelet reactivity in platelet reactivity units (PRU)0.5 hour post randomization

  • Platelet reactivity in platelet reactivity units (PRU)at hour 4 [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    Platelet reactivity in platelet reactivity units (PRU)4 hours post randomization

  • High platelet reactivity rate (208 PRU threshold) at 0.5 hour [ Time Frame: 0.5 hour ] [ Designated as safety issue: No ]
    High platelet reactivity rate (208 PRU threshold) 0.5 hour post randomization

  • High platelet reactivity rate (208 PRU threshold) at 1 hour [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    High platelet reactivity rate (208 PRU threshold) 1 hour post randomization

  • High platelet reactivity rate (208 PRU threshold) at 2 hour [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    High platelet reactivity rate (208 PRU threshold) 2 hours post randomization

  • High platelet reactivity rate (208 PRU threshold) at 4 hour [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    High platelet reactivity rate (208 PRU threshold) 4 hours post randomization


Enrollment: 82
Study Start Date: June 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01835353

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

No publications provided by University of Patras

Additional 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
Study First Received: April 15, 2013
Last Updated: September 20, 2013
Health Authority: Greece: Ethics Committee

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

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Prasugrel
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014