Ticagrelor in Clopidogrel Resistant Patients Undergoing Chronic Hemodialysis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dimitrios Alexopoulos, University of Patras
ClinicalTrials.gov Identifier:
NCT01511471
First received: January 12, 2012
Last updated: February 2, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Platelet Reactivity
Drug: Ticagrelor
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ticagrelor in Clopidogrel Resistant Patients Undergoing Chronic Hemodialysis

Resource links provided by NLM:


Further study details as provided by University of Patras:

Primary Outcome Measures:
  • Platelet reactivity assessed by VerifyNow P2Y12 assay [ Time Frame: Day 15 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bleeding events according to TIMI criteria [ Time Frame: Day 15 ] [ Designated as safety issue: Yes ]
    Major, minor or minimal bleeding events according to TIMI criteria

  • Major adverse cardiovascular events [ Time Frame: Day 15 ] [ Designated as safety issue: Yes ]
    Death, non-fatal myocardial infarction and stroke


Enrollment: 20
Study Start Date: January 2012
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ticagrelor
Ticagrelor 90mg twice a day for 15 days
Drug: Ticagrelor
Ticagrelor 90mg twice a day for 15 days

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01511471

Locations
Greece
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
  More Information

No publications provided

Responsible Party: Dimitrios Alexopoulos, Clinical Professor, University of Patras
ClinicalTrials.gov Identifier: NCT01511471     History of Changes
Other Study ID Numbers: PATRASCARDIOLOGY-9
Study First Received: January 12, 2012
Last Updated: February 2, 2012
Health Authority: Greece: Ethics Committee

Keywords provided by University of Patras:
Ticagrelor
platelet reactivity
clopidogrel
haemodialysis

Additional relevant MeSH terms:
Clopidogrel
Ticagrelor
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

ClinicalTrials.gov processed this record on August 27, 2014