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

This study has been completed.
Sponsor:
Information provided by:
University of Patras
ClinicalTrials.gov Identifier:
NCT01155765
First received: July 1, 2010
Last updated: November 15, 2010
Last verified: April 2010

July 1, 2010
November 15, 2010
May 2010
July 2010   (final data collection date for primary outcome measure)
Platelet Reactivity Units (PRU)assessed by VerifyNow P2Y12(Accumetrics) [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01155765 on ClinicalTrials.gov Archive Site
  • Major Adverse Cardiac Events (death, myocardial infarction, revascularization) [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
  • Hemorrhage [ Time Frame: Day 30 ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: Day 30 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Prasugrel Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Undergoing Chronic Hemodialysis
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Hemodialysis
  • Chronic Renal Failure
  • Drug: Prasugrel
    Prasugrel 10 mg/day for 15 days
  • Drug: Clopidogrel
    Clopidogrel 150 mg/day for 15 days
  • Experimental: Prasugrel
    Prasugrel per os 10 mg/day
    Intervention: Drug: Prasugrel
  • Active Comparator: Clopidogrel
    Clopidogrel per os 150 mg/day
    Intervention: Drug: Clopidogrel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
July 2010
July 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT01155765
PATRASCARDIOLOGY-2
No
Dimitrios Alexopoulos, Patras University Hospital
University of Patras
Not Provided
Not Provided
University of Patras
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP