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Prasugrel Versus High Dose Clopidogrel in Clopidogrel Resistant Patients 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: NCT01109784
Recruitment Status : Completed
First Posted : April 23, 2010
Last Update Posted : August 24, 2010
Information provided by:
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. Additionally, clopidogrel resistance has been linked with the CYP2C19 polymorphism. The hypothesis of the study is to define in consecutive patients undergoing PCI those that are clopidogrel resistant PCI following routinely used loading as estimated predischarge with the VerifyNow point of care system of platelet reactivity. Clopidogrel resistant patients will be randomized in 1:1 fashion to prasugrel 10 mg or clopidogrel 150mg daily. Platelet reactivity will be assessed at day 30, when treatment crossover will be performed. At day 60 platelet reactivity will be determined as well. In addition, in all patients genetic determination of CYP polymorphisms (including the CYP2C19)known to affect clopidogrel metabolism will be performed.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease (CAD) Acute Coronary Syndrome (ACS) Drug: prasugrel Drug: clopidogrel Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Prasugrel vs High Dose (150 mg) Clopidogrel in Clopidogrel Resistant Patients Post Coronary Angioplasty.
Study Start Date : April 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: prasugrel
prasugrel per os 10mg/day
Drug: prasugrel
prasugrel 10 mg/day

Active Comparator: clopidogrel
clopidogrel per os 150mg/day
Drug: clopidogrel
clopidogrel per os 150mg/day

Primary Outcome Measures :
  1. Platelet Reactivity Units (PRU) assessed by VerifyNow P2Y12(Accumetrics) [ Time Frame: Day 60 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age ≥18 years old
  • Patients having PCI with stenting 24-48 hours prior randomization, for 1. Stable angina 2.Ischaemia in provocative test 3.Acute coronary syndrome (unstable angina or myocardial infarction)
  • Written Informed consent
  • Platelet reactivity units (PRU) (VerifyNow) >230

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 60 days
  • Hemodynamic instability
  • Cancer or hemodialysis
  • Platelet count <100 000/ μL, hematocrit <30%
  • Creatinine clearance <25 ml/min
  • A life expectancy<1 year, inability to give informed consent
  • High likelihood of being unavailable for the Day 60 follow up

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): NCT01109784

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dimitrios Alexopoulos, Patras University Hospital Identifier: NCT01109784     History of Changes
Other Study ID Numbers: PATRASCARDIOLOGY-1
First Posted: April 23, 2010    Key Record Dates
Last Update Posted: August 24, 2010
Last Verified: April 2010
Keywords provided by University of Patras:
coronary angioplasty
clopidogrel resistance
Additional relevant MeSH terms:
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Coronary Artery Disease
Acute Coronary Syndrome
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
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