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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01463150
Recruitment Status : Completed
First Posted : November 1, 2011
Last Update Posted : July 11, 2012
Information provided by (Responsible Party):
Dimitrios Alexopoulos, University of Patras

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.

Condition or disease Intervention/treatment Phase
Platelet Reactivity Drug: Clopidogrel Drug: Prasugrel Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Clopidogrel
Clopidogrel 150mg per day for 15 days
Drug: Clopidogrel
Clopidogrel 150mg per day for 15 days
Experimental: Prasugrel
Prasugrel 5mg for 15 days
Drug: Prasugrel
Prasugrel 5mg per day for 15 days

Primary Outcome Measures :
  1. Platelet reactivity [ Time Frame: 15 days ]
    Platelet reactivity assessed with the VerifyNow assay at the end of each treatment period

Secondary Outcome Measures :
  1. Hyporesponsiveness rate (PRU≥235) at the end of the 2 treatment periods [ Time Frame: 15 days ]
    Hyporesponsiveness rate will be assessed 15 days after the onset of each study drug

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01463150

Cardiology Department Patras University Hospital
Rio, Achaia, Greece, 26500
Sponsors and Collaborators
University of Patras

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dimitrios Alexopoulos, Professor, University of Patras Identifier: NCT01463150     History of Changes
Other Study ID Numbers: PATRASCARDIOLOGY-7
First Posted: November 1, 2011    Key Record Dates
Last Update Posted: July 11, 2012
Last Verified: April 2012

Keywords provided by Dimitrios Alexopoulos, University of Patras:
Platelet reactivity

Additional relevant MeSH terms:
Prasugrel Hydrochloride
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors