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Prasugrel 5mg Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Aged ≥75 Years and/or Weighing <60 kg Post Percutaneous Coronary Intervention (PCI)

Primary Purpose

Platelet Reactivity

Status
Completed
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Clopidogrel
Prasugrel
Sponsored by
University of Patras
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Platelet Reactivity focused on measuring Platelet reactivity, Clopidogrel, Prasugrel

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥18 years old
  2. Patients having PCI with stenting 24 hours prior randomization, meeting the following criteria :

    • Acute coronary syndrome (unstable angina or myocardial infarction)
    • TIMI risk score>2
  3. Platelet reactivity in PRU ≥235 24 hours post-PCI
  4. Age≥75 years and/or weight<60 Kg

4. Informed consent obtained in writing

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 30 days
  • Hemodynamic instability
  • hemodialysis
  • Creatinine clearance <25 ml/min
  • inability to give informed consent
  • High likelihood of being unavailable for the Day 30
  • History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months.
  • Other bleeding diathesis, or considered by investigator to be at high risk for bleeding on longterm antiplatelet therapy.
  • Any previous history of ischemic stroke, transient ischemic attack, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).
  • Thrombocytopenia (<100.000 / μL) at randomization
  • Anaemia (Hct <30%) at randomization
  • Polycythaemia (Hct > 52%) at randomization
  • Periprocedural IIb/IIIa inhibitor administration

Sites / Locations

  • Cardiology Department Patras University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Clopidogrel

Prasugrel

Arm Description

Clopidogrel 150mg per day for 15 days

Prasugrel 5mg for 15 days

Outcomes

Primary Outcome Measures

Platelet reactivity
Platelet reactivity assessed with the VerifyNow assay at the end of each treatment period

Secondary Outcome Measures

Hyporesponsiveness rate (PRU≥235) at the end of the 2 treatment periods
Hyporesponsiveness rate will be assessed 15 days after the onset of each study drug

Full Information

First Posted
October 27, 2011
Last Updated
July 10, 2012
Sponsor
University of Patras
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1. Study Identification

Unique Protocol Identification Number
NCT01463150
Brief Title
Prasugrel 5mg Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Aged ≥75 Years and/or Weighing <60 kg Post Percutaneous Coronary Intervention (PCI)
Official Title
Prasugrel 5mg Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Aged ≥75 Years and/or Weighing <60 kg Post Percutaneous Coronary Intervention (PCI)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (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
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. The aim of the study is to define in consecutive patients with acute coronary syndrome (ACS) undergoing PCI, those aged>75years and/or weighted<60 Kg with high on-clopidogrel platelet reactivity (Platelet Reactivity Units-PRU≥235) as estimated 24 hours post PCI with the VerifyNow assay. Those patients will be randomized after informed concent in 1:1 fashion to prasugrel 5 mg or clopidogrel 150mg daily. Platelet reactivity will be assessed at day 15 and then treatment crossover will be performed. At day 30 platelet reactivity will be determined as well.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Platelet Reactivity
Keywords
Platelet reactivity, Clopidogrel, Prasugrel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clopidogrel
Arm Type
Active Comparator
Arm Description
Clopidogrel 150mg per day for 15 days
Arm Title
Prasugrel
Arm Type
Experimental
Arm Description
Prasugrel 5mg for 15 days
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
Clopidogrel 150mg per day for 15 days
Intervention Type
Drug
Intervention Name(s)
Prasugrel
Intervention Description
Prasugrel 5mg per day for 15 days
Primary Outcome Measure Information:
Title
Platelet reactivity
Description
Platelet reactivity assessed with the VerifyNow assay at the end of each treatment period
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Hyporesponsiveness rate (PRU≥235) at the end of the 2 treatment periods
Description
Hyporesponsiveness rate will be assessed 15 days after the onset of each study drug
Time Frame
15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years old Patients having PCI with stenting 24 hours prior randomization, meeting the following criteria : Acute coronary syndrome (unstable angina or myocardial infarction) TIMI risk score>2 Platelet reactivity in PRU ≥235 24 hours post-PCI Age≥75 years and/or weight<60 Kg 4. Informed consent obtained in writing 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 30 days Hemodynamic instability hemodialysis Creatinine clearance <25 ml/min inability to give informed consent High likelihood of being unavailable for the Day 30 History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months. Other bleeding diathesis, or considered by investigator to be at high risk for bleeding on longterm antiplatelet therapy. Any previous history of ischemic stroke, transient ischemic attack, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm). Thrombocytopenia (<100.000 / μL) at randomization Anaemia (Hct <30%) at randomization Polycythaemia (Hct > 52%) at randomization Periprocedural IIb/IIIa inhibitor administration
Facility Information:
Facility Name
Cardiology Department Patras University Hospital
City
Rio
State/Province
Achaia
ZIP/Postal Code
26500
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
23237136
Citation
Alexopoulos D, Xanthopoulou I, Plakomyti TE, Theodoropoulos KC, Mavronasiou E, Damelou A, Hahalis G, Davlouros P. Pharmacodynamic effect of prasugrel 5 mg vs clopidogrel 150 mg in elderly patients with high on-clopidogrel platelet reactivity. Am Heart J. 2013 Jan;165(1):73-9. doi: 10.1016/j.ahj.2012.10.008. Epub 2012 Nov 14.
Results Reference
derived

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Prasugrel 5mg Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Aged ≥75 Years and/or Weighing <60 kg Post Percutaneous Coronary Intervention (PCI)

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