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Prasugrel Versus High Dose Clopidogrel in Patients With Stable Coronary Artery Disease and High Platelet Reactivity While on Chronic Clopidogrel Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dimitrios Alexopoulos, University of Patras
ClinicalTrials.gov Identifier:
NCT01304472
First received: February 24, 2011
Last updated: August 21, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease (CAD)
 Drug: Prasugrel
Drug: Clopidogrel
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prasugrel Versus High Dose Clopidogrel in Patients With Stable Coronary Artery Disease and High Platelet Reactivity While on Chronic Clopidogrel Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Patras:

Primary Outcome Measures:
  • Change in Platelet Reactivity [ Time Frame: At 14 and 28 days after randomization ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 25
Study Start Date: February 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prasugrel
Prasugrel 10mg per day
 Drug: Prasugrel
Prasugrel 10mg per day
Active Comparator: Clopidogrel Drug: Clopidogrel
Clopidogrel 150mg per day

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01304472

Locations
Greece
Patras University Hospital Cardiology Department
Patras, Greece, 26500
Dimitrios Alexopoulos
Patras, Greece, 26500
Sponsors and Collaborators
University of Patras
  More Information

No publications provided

Responsible Party: Dimitrios Alexopoulos, Professor, University of Patras
ClinicalTrials.gov Identifier: NCT01304472     History of Changes
Other Study ID Numbers: PATRASCARDIOLOGY-3
Study First Received: February 24, 2011
Last Updated: August 21, 2011
Health Authority: Greece: Ethics Committee

Keywords provided by University of Patras:
coronary angioplasty
clopidogrel resistance
prasugrel

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
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 16, 2013