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Clinical Trials/NCT01109784
NCT01109784
Completed
Phase 3

Phase 3 Study of Prasugrel vs High Dose (150 mg) Clopidogrel in Clopidogrel Resistant Patients Post Coronary Angioplasty.

University of Patras1 site in 1 country70 target enrollmentApril 2010

Overview

Phase
Phase 3
Intervention
prasugrel
Conditions
Coronary Artery Disease (CAD)
Sponsor
University of Patras
Enrollment
70
Locations
1
Primary Endpoint
Platelet Reactivity Units (PRU) assessed by VerifyNow P2Y12(Accumetrics)
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 2010
End Date
July 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Age ≥18 years old
  • Patients having PCI with stenting 24-48 hours prior randomization, for
  • 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%

Arms & Interventions

prasugrel

prasugrel per os 10mg/day

Intervention: prasugrel

clopidogrel

clopidogrel per os 150mg/day

Intervention: clopidogrel

Outcomes

Primary Outcomes

Platelet Reactivity Units (PRU) assessed by VerifyNow P2Y12(Accumetrics)

Time Frame: Day 60

Study Sites (1)

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