Skip to main content
OpenTrials
Completed

NCT Number: NCT01511471

Ticagrelor in Clopidogrel Resistant Patients Undergoing Chronic Hemodialysis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Platelet Reactivity

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Agios Andreas General Hospital, Nephrology Department, Pátrai, Achaia, Greece

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ticagrelor

Drug

Ticagrelor 90mg twice a day for 15 days

Primary outcomes

  1. Platelet reactivity assessed by VerifyNow P2Y12 assay

    Time frame: Day 15

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Patras

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 18, 2012
Registry last updated
Feb 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.