Ticagrelor in Clopidogrel Resistant Patients Undergoing Chronic Hemodialysis

Study Overview
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Brief Summary
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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.

Official Title
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Ticagrelor in Clopidogrel Resistant Patients Undergoing Chronic Hemodialysis

Conditions
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Platelet Reactivity

Intervention / Treatment
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* Drug: Ticagrelor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ticagrelor<br>Ticagrelor 90mg twice a day for 15 days | Drug: Ticagrelor<br>* Ticagrelor 90mg twice a day for 15 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ticagrelor, platelet reactivity, clopidogrel, haemodialysis