Back to resultsONSET and OFFSET of Ticagrelor in ESRD
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ticagrelor
Clopidogrel
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring platelet, ticagrelor, clopidogrel, end stage renal disease, hemodialysis
Eligibility Criteria
Inclusion Criteria:
- ESRD patients undergoing regular (≥ 6 months) maintenance HD
- ongoing (≥ 2 months) treatment with clopidogrel
- P2Y12 reaction units (PRUs) were more than 235
Exclusion Criteria:
- known allergies to aspirin, clopidogrel, or ticagrelor
- concomitant use of other antithrombotic drugs (oral anticoagulants, dipyridamole)
- thrombocytopenia (platelet count <100,000/mm3)
- hematocrit <25%
- uncontrolled hyperglycemia (hemoglobin A1c >10%)
- liver disease (bilirubin level >2 mg/dl)
- symptomatic severe pulmonary disease
- active bleeding or bleeding diathesis
- gastrointestinal bleeding within the last 6 months
- hemodynamic instability
- acute coronary or cerebrovascular event within the last 3 months
- pregnancy
- any malignancy
- concomitant use of a cytochrome P450 inhibitor or nonsteroidal anti-inflammatory drug
- recent treatment (<30 days) with a glycoprotein IIb/IIIa antagonist
Sites / Locations
- Kyung Hee University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Clopidogrel
Ticagrelor
Arm Description
Patients treated with clopidogrel for 14 days
Patients treated with ticagrelor for 14 days
Outcomes
Primary Outcome Measures
The difference of antiplatelet effects assessed by VerifyNow assay
The difference of PRU values achieved following antiplatelet therapy
Secondary Outcome Measures
the rate of onset and offset of the antiplatelet effects
the difference of slope during onset and offset of study drugs
Full Information
NCT ID
NCT02163954
First Posted
June 12, 2014
Last Updated
June 12, 2014
Sponsor
Kyunghee University Medical Center
Collaborators
Kyunghee University
1. Study Identification
Unique Protocol Identification Number
NCT02163954
Brief Title
ONSET and OFFSET of Ticagrelor in ESRD
Official Title
Platelet Reactivity in Patients With End Stage Renal Disease Receiving Clopidogrel Compared With Ticagrelor
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyunghee University Medical Center
Collaborators
Kyunghee University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients with severe chronic kidney disease or end stage renal disease (ESRD) on hemodialysis (HD) exhibited higher platelet reactivity to clopidogrel than did those with normal renal function. Not enough study has been conducted about the antiplatelet effects of ticagrelor in these cardiovascular high risk patients. We hypothesized ticagrelor would achieve more and faster antiplatelet effects compared with clopidogrel in ESRD patients on HD.
Detailed Description
Chronic kidney disease (CKD) is a strong risk factor for cardiovascular morbidity and mortality, and confers an increasing risk of stent thrombosis even when dual antiplatelet therapy (clopidogrel and aspirin) is administered. Recently, we demonstrated that patients with severe CKD or end stage renal disease (ESRD) on hemodialysis (HD) exhibited higher platelet reactivity to clopidogrel than did those with normal renal function. One of good option to overcome high platelet reactivity in ESRD patients would be ticagrelor which has been already shown improved clinical outcomes. But little is known the antiplatelet effects of ticagrelor in ESRD patients on HD. The present study was designed to determine the antiplatelet effect as well as the onset and offset action of ticagrelor compared with clopidogrel in patients with ESRD undergoing maintenance HD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
platelet, ticagrelor, clopidogrel, end stage renal disease, hemodialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clopidogrel
Arm Type
Active Comparator
Arm Description
Patients treated with clopidogrel for 14 days
Arm Title
Ticagrelor
Arm Type
Experimental
Arm Description
Patients treated with ticagrelor for 14 days
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Other Intervention Name(s)
Ticagrelor (Brilinta)
Intervention Description
After randomization, an initial loading dose of ticagrelor (180 mg) was given and maintenance doses (ticagrelor 90 mg twice daily) was treated for 14 days.
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Other Intervention Name(s)
Clopidogrel (Plavix)
Intervention Description
After randomization, an initial loading dose of clopidogrel (300 mg) was given and maintenance doses (clopidogrel 75 mg once daily) was treated for 14 days.
Primary Outcome Measure Information:
Title
The difference of antiplatelet effects assessed by VerifyNow assay
Description
The difference of PRU values achieved following antiplatelet therapy
Time Frame
14 days after study drug treatment
Secondary Outcome Measure Information:
Title
the rate of onset and offset of the antiplatelet effects
Description
the difference of slope during onset and offset of study drugs
Time Frame
14 days after study drugs treatment
Other Pre-specified Outcome Measures:
Title
Adverse events
Description
Adverse events such as bleeding
Time Frame
during study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ESRD patients undergoing regular (≥ 6 months) maintenance HD
ongoing (≥ 2 months) treatment with clopidogrel
P2Y12 reaction units (PRUs) were more than 235
Exclusion Criteria:
known allergies to aspirin, clopidogrel, or ticagrelor
concomitant use of other antithrombotic drugs (oral anticoagulants, dipyridamole)
thrombocytopenia (platelet count <100,000/mm3)
hematocrit <25%
uncontrolled hyperglycemia (hemoglobin A1c >10%)
liver disease (bilirubin level >2 mg/dl)
symptomatic severe pulmonary disease
active bleeding or bleeding diathesis
gastrointestinal bleeding within the last 6 months
hemodynamic instability
acute coronary or cerebrovascular event within the last 3 months
pregnancy
any malignancy
concomitant use of a cytochrome P450 inhibitor or nonsteroidal anti-inflammatory drug
recent treatment (<30 days) with a glycoprotein IIb/IIIa antagonist
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weon Kim, MD, PhD
Organizational Affiliation
Kyung Hee University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyung Hee University Hospital
City
Seoul
ZIP/Postal Code
130-702
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
35224730
Citation
Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
Results Reference
derived
Learn more about this trial
ONSET and OFFSET of Ticagrelor in ESRD
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