Status:
COMPLETED
Ticagrelor in Clopidogrel Resistant Patients Undergoing Chronic Hemodialysis
Lead Sponsor:
University of Patras
Conditions:
Platelet Reactivity
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
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. P...
Eligibility Criteria
Inclusion
- Age≥18 years
- Chronic renal failure under haemodialysis
- Platelet reactivity under clopidogrel 75mgx1 ≥235 PRU
- Informed written consent
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01511471
Start Date
January 1 2012
End Date
February 1 2012
Last Update
February 3 2012
Active Locations (2)
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1
Agios Andreas General Hospital, Nephrology Department
Pátrai, Achaia, Greece, 26500
2
Cardiology Department Patras University Hospital
Rio, Achaia, Greece, 26500