Prasugrel Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Post Percutaneous Coronary Intervention (PCI).

This study has been completed.
Sponsor:
Information provided by:
University of Patras
ClinicalTrials.gov Identifier:
NCT01109784
First received: April 22, 2010
Last updated: August 23, 2010
Last verified: April 2010

April 22, 2010
August 23, 2010
April 2010
July 2010   (final data collection date for primary outcome measure)
Platelet Reactivity Units (PRU) assessed by VerifyNow P2Y12(Accumetrics) [ Time Frame: Day 60 ] [ Designated as safety issue: No ]
PRU assessed by VerifyNow P2Y12(Accumetrics) [ Time Frame: Day 60 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01109784 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
Prasugrel Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Post Percutaneous Coronary Intervention (PCI).
Phase 3 Study of Prasugrel vs High Dose (150 mg) Clopidogrel in Clopidogrel Resistant Patients Post Coronary Angioplasty.

The use of dual antiplatelet therapy is considered standard of care in patients post percutaneous coronary intervention (PCI) with stenting. However, a significant proportion of patients is considered clopidogrel resistant and this resistance is shown to be accompanied by future adverse events. Additionally, clopidogrel resistance has been linked with the CYP2C19 polymorphism. The hypothesis of the study is to define in consecutive patients undergoing PCI those that are clopidogrel resistant PCI following routinely used loading as estimated predischarge with the VerifyNow point of care system of platelet reactivity. Clopidogrel resistant patients will be randomized in 1:1 fashion to prasugrel 10 mg or clopidogrel 150mg daily. Platelet reactivity will be assessed at day 30, when treatment crossover will be performed. At day 60 platelet reactivity will be determined as well. In addition, in all patients genetic determination of CYP polymorphisms (including the CYP2C19)known to affect clopidogrel metabolism will be performed.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Coronary Artery Disease (CAD)
  • Acute Coronary Syndrome (ACS)
  • Drug: prasugrel
    prasugrel 10 mg/day
  • Drug: clopidogrel
    clopidogrel per os 150mg/day
  • Experimental: prasugrel
    prasugrel per os 10mg/day
    Intervention: Drug: prasugrel
  • Active Comparator: clopidogrel
    clopidogrel per os 150mg/day
    Intervention: Drug: clopidogrel
Alexopoulos D, Dimitropoulos G, Davlouros P, Xanthopoulou I, Kassimis G, Stavrou EF, Hahalis G, Athanassiadou A. Prasugrel overcomes high on-clopidogrel platelet reactivity post-stenting more effectively than high-dose (150-mg) clopidogrel: the importance of CYP2C19*2 genotyping. JACC Cardiovasc Interv. 2011 Apr;4(4):403-10. doi: 10.1016/j.jcin.2010.12.011.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age ≥18 years old
  • Patients having PCI with stenting 24-48 hours prior randomization, for 1. Stable angina 2.Ischaemia in provocative test 3.Acute coronary syndrome (unstable angina or myocardial infarction)
  • Written Informed consent
  • Platelet reactivity units (PRU) (VerifyNow) >230

Exclusion Criteria:

  • A history of bleeding diathesis
  • Chronic oral anticoagulation treatment
  • Contraindications to antiplatelet therapy
  • Known platelet function disorders
  • PCI or coronary artery bypass surgery < 3 months
  • Unsuccessful PCI (residual stenosis > 30% or flow < Thrombolysis in myocardial infarction flow 3)
  • Planned staged PCI in the next 60 days
  • Hemodynamic instability
  • Cancer or hemodialysis
  • Platelet count <100 000/ μL, hematocrit <30%
  • Creatinine clearance <25 ml/min
  • A life expectancy<1 year, inability to give informed consent
  • High likelihood of being unavailable for the Day 60 follow up
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT01109784
PATRASCARDIOLOGY-1
No
Dimitrios Alexopoulos, Patras University Hospital
University of Patras
Not Provided
Not Provided
University of Patras
April 2010

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