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.

Study Overview

• Status: Completed
• Conditions: Platelet Reactivity
• Intervention / Treatment: Drug: Ticagrelor

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

• Greece
  • Achaia
    • Patras, Achaia, Greece, 26500
      • Agios Andreas General Hospital, Nephrology Department
    • Rio, Achaia, Greece, 26500
      • Cardiology Department Patras University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ticagrelor; Ticagrelor 90mg twice a day for 15 days	Drug: Ticagrelor; Ticagrelor 90mg twice a day for 15 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Platelet reactivity assessed by VerifyNow P2Y12 assay	Day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding events according to TIMI criteria	Major, minor or minimal bleeding events according to TIMI criteria	Day 15
Major adverse cardiovascular events	Death, non-fatal myocardial infarction and stroke	Day 15

Collaborators and Investigators

• Sponsor: University of Patras

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: January 12, 2012
• First Submitted That Met QC Criteria: January 12, 2012
• First Posted (Estimate): January 18, 2012

Study Record Updates

• Last Update Posted (Estimate): February 3, 2012
• Last Update Submitted That Met QC Criteria: February 2, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Ticagrelor; clopidogrel; platelet reactivity; haemodialysis
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Ticagrelor
• Other Study ID Numbers: PATRASCARDIOLOGY-9

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No