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

April 15, 2013
September 20, 2013
June 2012
July 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01835353 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
High (100mg) Versus Standard (60mg) Loading Dose of Prasugrel in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)
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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Platelet Reactivity
  • Drug: Prasugrel 100mg loading dose
  • Drug: Prasugrel 60mg loading dose
    Prasugrel 60mg loading dose
  • Experimental: Prasugrel 100mg loading dose
    Prasugrel 100mg loading dose
    Intervention: Drug: Prasugrel 100mg loading dose
  • Active Comparator: Prasugrel 60mg loading dose
    Intervention: Drug: Prasugrel 60mg loading dose
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT01835353
PATRASCARDIOLOGY-13
No
Dimitrios Alexopoulos, University of Patras
University of Patras
Not Provided
Not Provided
University of Patras
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP