Prasugrel Versus High Dose Clopidogrel in Patients With Stable Coronary Artery Disease and High Platelet Reactivity While on Chronic Clopidogrel Treatment
1 other identifier
interventional
25
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2011
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 24, 2011
CompletedFirst Posted
Study publicly available on registry
February 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedAugust 23, 2011
August 1, 2011
2 months
February 24, 2011
August 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
At 14 and 28 days after randomization
Study Arms (2)
Prasugrel
EXPERIMENTALPrasugrel 10mg per day
Clopidogrel
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Dimitrios Alexopoulos
Pátrai, 26500, Greece
Patras University Hospital Cardiology Department
Pátrai, 26500, Greece
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 24, 2011
First Posted
February 25, 2011
Study Start
February 1, 2011
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
August 23, 2011
Record last verified: 2011-08