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Prasugrel Versus High Dose Clopidogrel in Patients With Stable Coronary Artery Disease and High Platelet Reactivity While on Chronic Clopidogrel Treatment

Primary Purpose

Coronary Artery Disease (CAD)

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

Inclusion Criteria:

  • Age ≥18 years old
  • Patients with history of coronary artery disease under chronic (≥ 6 months) clopidogrel treatment
  • High on-clopidogrel platelet reactivity (≥235 Platelet Reactivity Units as assessed with the VerifyNow assay)
  • Written Informed Consent

Exclusion Criteria:

  • History of bleeding diathesis
  • History of active bleeding within 6 months before randomization
  • Chronic oral anticoagulation treatment
  • Contraindications to antiplatelet treatment
  • Known platelet function disorders
  • Acute coronary syndrome within 30 days before randomization
  • Cardiogenic shock
  • Planned Percutaneous Coronary Intervention in the next 30 days
  • Cancer
  • Haemodialysis
  • Platelet count < 100000/μL
  • Hematocrit < 30%
  • High likelihood of being unavailable on the Day 28 visit
  • History of stroke
  • Known allergy to clopidogrel and/or prasugrel

Sites / Locations

  • Dimitrios Alexopoulos
  • Patras University Hospital Cardiology Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prasugrel

Clopidogrel

Arm Description

Prasugrel 10mg per day

Outcomes

Primary Outcome Measures

Change in Platelet Reactivity
Platelet reactivity in Platelet Reactivity Units (PRU) as assessed with the VerifyNow point of care assay will be measured at the end of the two treatment periods, namely at 14 and 28 days after randomization

Secondary Outcome Measures

Full Information

First Posted
February 24, 2011
Last Updated
August 21, 2011
Sponsor
University of Patras
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1. Study Identification

Unique Protocol Identification Number
NCT01304472
Brief Title
Prasugrel Versus High Dose Clopidogrel in Patients With Stable Coronary Artery Disease and High Platelet Reactivity While on Chronic Clopidogrel Treatment
Official Title
Prasugrel Versus High Dose Clopidogrel in Patients With Stable Coronary Artery Disease and High Platelet Reactivity While on Chronic Clopidogrel Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Patras

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Clopidogrel administration is considered standard of care in patients with stable coronary artery disease post PCI. However , a significant proportion of patients is considered clopidogrel resistant and this is shown to be accompanied by future adverse events. The hypothesis of the study is to define among consecutive outpatient clinics individuals with stable coronary artery disease being on chronic clopidogrel treatment, those that are clopidogrel resistant, as assessed with the VerifyNow point of care assay. Clopidogrel resistant patients will be randomized in a 1:1 fashion to either prasugrel 10mg or clopidogrel 150mg daily. Platelet reactivity will be assessed at Day 14, when treatment crossover will be performed without a washout period. At Day 28 platelet reactivity will be assessed as well.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease (CAD)
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
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prasugrel
Arm Type
Experimental
Arm Description
Prasugrel 10mg per day
Arm Title
Clopidogrel
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Prasugrel
Intervention Description
Prasugrel 10mg per day
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
Clopidogrel 150mg per day
Primary Outcome Measure Information:
Title
Change in Platelet Reactivity
Description
Platelet reactivity in Platelet Reactivity Units (PRU) as assessed with the VerifyNow point of care assay will be measured at the end of the two treatment periods, namely at 14 and 28 days after randomization
Time Frame
At 14 and 28 days after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years old Patients with history of coronary artery disease under chronic (≥ 6 months) clopidogrel treatment High on-clopidogrel platelet reactivity (≥235 Platelet Reactivity Units as assessed with the VerifyNow assay) Written Informed Consent Exclusion Criteria: History of bleeding diathesis History of active bleeding within 6 months before randomization Chronic oral anticoagulation treatment Contraindications to antiplatelet treatment Known platelet function disorders Acute coronary syndrome within 30 days before randomization Cardiogenic shock Planned Percutaneous Coronary Intervention in the next 30 days Cancer Haemodialysis Platelet count < 100000/μL Hematocrit < 30% High likelihood of being unavailable on the Day 28 visit History of stroke Known allergy to clopidogrel and/or prasugrel
Facility Information:
Facility Name
Dimitrios Alexopoulos
City
Patras
ZIP/Postal Code
26500
Country
Greece
Facility Name
Patras University Hospital Cardiology Department
City
Patras
ZIP/Postal Code
26500
Country
Greece

12. IPD Sharing Statement

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Prasugrel Versus High Dose Clopidogrel in Patients With Stable Coronary Artery Disease and High Platelet Reactivity While on Chronic Clopidogrel Treatment

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