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Completed

NCT Number: NCT01835353

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

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.

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Key information

Conditions

Platelet Reactivity Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dimitrios Alexopoulos

Pátrai, Achaia, 26500, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prasugrel 100mg loading dose

Drug

Prasugrel 60mg loading dose

Drug

Prasugrel 60mg loading dose

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Patras

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 18, 2013
Registry last updated
Sep 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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