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

Primary Purpose

Coronary Artery Disease (CAD), Acute Coronary Syndrome (ACS)

Status
Completed
Phase
Phase 3
Locations
Greece
Study Type
Interventional
Intervention
prasugrel
clopidogrel
Sponsored by
University of Patras
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease (CAD) focused on measuring coronary angioplasty, clopidogrel resistance, prasugrel

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiology Department, Patras University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

prasugrel

clopidogrel

Arm Description

prasugrel per os 10mg/day

clopidogrel per os 150mg/day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 22, 2010
Last Updated
August 23, 2010
Sponsor
University of Patras
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1. Study Identification

Unique Protocol Identification Number
NCT01109784
Brief Title
Prasugrel Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Post Percutaneous Coronary Intervention (PCI).
Official Title
Phase 3 Study of Prasugrel vs High Dose (150 mg) Clopidogrel in Clopidogrel Resistant Patients Post Coronary Angioplasty.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Patras

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease (CAD), Acute Coronary Syndrome (ACS)
Keywords
coronary angioplasty, clopidogrel resistance, prasugrel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
prasugrel
Arm Type
Experimental
Arm Description
prasugrel per os 10mg/day
Arm Title
clopidogrel
Arm Type
Active Comparator
Arm Description
clopidogrel per os 150mg/day
Intervention Type
Drug
Intervention Name(s)
prasugrel
Intervention Description
prasugrel 10 mg/day
Intervention Type
Drug
Intervention Name(s)
clopidogrel
Intervention Description
clopidogrel per os 150mg/day
Primary Outcome Measure Information:
Title
Platelet Reactivity Units (PRU) assessed by VerifyNow P2Y12(Accumetrics)
Time Frame
Day 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Cardiology Department, Patras University Hospital
City
Rio, Patras
ZIP/Postal Code
26500
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
21511219
Citation
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.
Results Reference
derived

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

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