Ticagrelor 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: NCT01511471
Recruitment Status : Completed
First Posted : January 18, 2012
Last Update Posted : February 3, 2012
Information provided by (Responsible Party):
Dimitrios Alexopoulos, University of Patras

Brief Summary:
Clopidogrel administration is commonly prescribed in patients undergoing percutaneous coronary intervention, in patients with previous stroke and in patients under chronic hemodialysis via fistulae. Patients with chronic renal failure present lower clopidogrel response compared to those with normal renal function. Ticagrelor is a new oral direct-acting antagonist, which provides greater platelet inhibition in both clopidogrel responders and non-responders. It has also been shown that in patients with chronic kidney disease (creatinine clearance <60 mL/min)ticagrelor achieved an absolute risk reduction of cardiovascular death, myocardial infarction, and stroke greater than that of patients with normal renal function. Clopidogrel resistant patients as assessed by VerifyNow P2Y12(Accumetrics)will be administered after informed consent ticagrelor 90 mg twice daily for 15 days. Platelet reactivity will be determined at the end of the treatment period. Bleeding events, major adverse cardiac events and any side effects until Day 15 will be reported in a descriptive manner.

Condition or disease Intervention/treatment Phase
Platelet Reactivity Drug: Ticagrelor Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ticagrelor in Clopidogrel Resistant Patients Undergoing Chronic Hemodialysis
Study Start Date : January 2012
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: Ticagrelor
Ticagrelor 90mg twice a day for 15 days
Drug: Ticagrelor
Ticagrelor 90mg twice a day for 15 days

Primary Outcome Measures :
  1. Platelet reactivity assessed by VerifyNow P2Y12 assay [ Time Frame: Day 15 ]

Secondary Outcome Measures :
  1. Bleeding events according to TIMI criteria [ Time Frame: Day 15 ]
    Major, minor or minimal bleeding events according to TIMI criteria

  2. Major adverse cardiovascular events [ Time Frame: Day 15 ]
    Death, non-fatal myocardial infarction and stroke

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age≥18 years
  • Chronic renal failure under haemodialysis
  • Platelet reactivity under clopidogrel 75mgx1 ≥235 PRU
  • Informed written consent

Exclusion Criteria:

  • Recent (within 1 month) PCI or ACS
  • Requirement for oral anticoagulant prior to the Day 14 visit
  • PLTs<100.000 / μL), Hct <28%, Hct > 52% at randomization
  • Increased risk of bradycardiac events.
  • Severe uncontrolled chronic obstructive pulmonary disease
  • Known severe hepatic impairment
  • History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months.
  • Other bleeding diathesis, or considered by investigator to be at high risk for bleeding
  • Concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer
  • Recent (<6weeks)major surgery including CABG
  • Recent (<6weeks)stroke or any prior intracranial bleeding

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): NCT01511471

Agios Andreas General Hospital, Nephrology Department
Patras, Achaia, Greece, 26500
Cardiology Department Patras University Hospital
Rio, Achaia, Greece, 26500
Sponsors and Collaborators
University of Patras

Responsible Party: Dimitrios Alexopoulos, Clinical Professor, University of Patras Identifier: NCT01511471     History of Changes
Other Study ID Numbers: PATRASCARDIOLOGY-9
First Posted: January 18, 2012    Key Record Dates
Last Update Posted: February 3, 2012
Last Verified: February 2012

Keywords provided by Dimitrios Alexopoulos, University of Patras:
platelet reactivity

Additional relevant MeSH terms:
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