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

About this trial
This is an interventional treatment trial for Platelet Reactivity focused on measuring Platelet reactivity, Clopidogrel, Prasugrel
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
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
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
Learn more about this trial
Prasugrel 5mg Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Aged ≥75 Years and/or Weighing <60 kg Post Percutaneous Coronary Intervention (PCI)
We'll reach out to this number within 24 hrs