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Prasugrel Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Undergoing Chronic Hemodialysis

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: NCT01155765
Recruitment Status : Completed
First Posted : July 2, 2010
Last Update Posted : November 16, 2010
Information provided by:
University of Patras

Brief Summary:
Clopidogrel administration is essential in patients undergoing percutaneous coronary intervention, in patients with previous stroke, in patients under chronic hemodialysis via fistulae and in patients with chronic atrial fibrillation if coumarin administration is not a viable option. Patients with chronic renal failure present lower clopidogrel response compared to those with normal renal function. Additionally, hemodialysis via the dialysis filter causes a decrease in glycoprotein platelet receptors, potentially associated with thienopyridine hyporesponsiveness. Clopidogrel resistant patients as assessed by VerifyNow P2Y12(Accumetrics)will be randomized in 1:1 fashion to prasugrel 10mg/day or clopidogrel 150mg/day. On day 15±2 days a crossover directly to the alternate treatment group will be carried out, without an interventing washout period. All patients will undergo platelet reactivity assessment, documentation of major adverse cardiac events and documentation of any serious adverse events(stroke, bleeding)at day 15 and day 30.

Condition or disease Intervention/treatment Phase
Hemodialysis Chronic Renal Failure 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: Prasugrel in Comparison to High Clopidogrel Dose for Inhibition of Platelet Reactivity as Assessed With a Point-of-Care Platelet Function Assay in Patients Undergoing Chronic Hemodialysis Presenting Resistance to the Usual Clopidogrel Dose
Study Start Date : May 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: Prasugrel
Prasugrel per os 10 mg/day
Drug: Prasugrel
Prasugrel 10 mg/day for 15 days

Active Comparator: Clopidogrel
Clopidogrel per os 150 mg/day
Drug: Clopidogrel
Clopidogrel 150 mg/day for 15 days

Primary Outcome Measures :
  1. Platelet Reactivity Units (PRU)assessed by VerifyNow P2Y12(Accumetrics) [ Time Frame: Day 30 ]

Secondary Outcome Measures :
  1. Major Adverse Cardiac Events (death, myocardial infarction, revascularization) [ Time Frame: Day 30 ]
  2. Hemorrhage [ Time Frame: Day 30 ]
  3. Stroke [ Time Frame: Day 30 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age ≥18 years old
  2. History of chronic renal failure under hemodialysis for at least 6 months
  3. Under clopidogrel 75mg/day treatment for at least 7 days before randomization
  4. Informed consent obtained in writing

Exclusion Criteria:

  1. Treatment with other investigational agents (including placebo) or devices within 30 days prior to randomization or planned use of investigational agents or devices prior to the Day 30 visit.
  2. Pregnancy
  3. Breastfeeding
  4. Inability to give informed consent or high likelihood of being unavailable for the Day 30 follow up.
  5. Malignancy
  6. Acute coronary syndrome or hemodynamic instability within 30 days prior to randomization
  7. Requirement for oral anticoagulant prior to the Day 30 visit
  8. Requirement for discontinuation of thienopyridine treatment prior to the Day 30 visit
  9. Treatment with IIb/IIIa inhibitors within 30 days prior to randomization or planned administration prior to the Day 30 visit
  10. Known hypersensitivity to prasugrel or clopidogrel.
  11. History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months.
  12. Other bleeding diathesis, or considered by investigator to be at high risk for bleeding on thienopyridine therapy.
  13. Any previous history of ischemic stroke, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).
  14. Thrombocytopenia (<100.000 / μL) at randomization
  15. Known liver failure (bilirubin > 2mg/dl)

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): NCT01155765

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Patras University Hospital
Patras, Achaia, Greece, 26500
Sponsors and Collaborators
University of Patras
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Responsible Party: Dimitrios Alexopoulos, Patras University Hospital Identifier: NCT01155765    
Other Study ID Numbers: PATRASCARDIOLOGY-2
First Posted: July 2, 2010    Key Record Dates
Last Update Posted: November 16, 2010
Last Verified: April 2010
Keywords provided by University of Patras:
Clopidogrel Resistance
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
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