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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dimitrios Alexopoulos, University of Patras
ClinicalTrials.gov Identifier:
NCT01463150
First received: October 27, 2011
Last updated: July 10, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
Platelet Reactivity
 Drug: Clopidogrel
Drug: Prasugrel
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Patras:

Primary Outcome Measures:
  • Platelet reactivity [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    Hyporesponsiveness rate will be assessed 15 days after the onset of each study drug


Enrollment: 27
Study Start Date: October 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463150

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

No publications provided by University of Patras

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dimitrios Alexopoulos, Professor, University of Patras
ClinicalTrials.gov Identifier: NCT01463150     History of Changes
Other Study ID Numbers: PATRASCARDIOLOGY-7
Study First Received: October 27, 2011
Last Updated: July 10, 2012
Health Authority: Greece: Ethics Committee

Keywords provided by University of Patras:
Platelet reactivity
Clopidogrel
Prasugrel

Additional relevant MeSH terms:
Clopidogrel
Ticlopidine
Prasugrel
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
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
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 22, 2013