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
  Purpose

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 Intervention Phase
Hemodialysis
Chronic Renal Failure
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 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

Resource links provided by NLM:


Further study details as provided by University of Patras:

Primary Outcome Measures:
  • Platelet Reactivity Units (PRU)assessed by VerifyNow P2Y12(Accumetrics) [ Time Frame: Day 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 70
Study Start Date: May 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01155765

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

No publications provided

Responsible Party: Dimitrios Alexopoulos, Patras University Hospital
ClinicalTrials.gov Identifier: NCT01155765     History of Changes
Other Study ID Numbers: PATRASCARDIOLOGY-2
Study First Received: July 1, 2010
Last Updated: November 15, 2010
Health Authority: Greece: Ethics Committee

Keywords provided by University of Patras:
Clopidogrel Resistance
prasugrel
Hemodialysis

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
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 September 29, 2014