- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02394145
Genotype and Platelet Reactivity in Patients on Hemodialysis
March 19, 2015 updated by: Weon Kim, Kyunghee University Medical Center
The Relationship Between Genotype and Platelet Reactivity in Patients Treated With Ticagrelor Versus Clopidogrel: PIANO Genotype Study
Patients with end stage renal disease (ESRD) on hemodialysis (HD) exhibited higher platelet reactivity to clopidogrel than did those with normal renal function.
We recently reported platelet inhibition by ticagrelor was faster and markedly greater than by clopidogrel with onset dosing regimen in patients with ESRD on HD.
However, few studies have been conducted genetic influence in high platelet reactivity in patients with ESRD on HD.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
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.
We recently reported platelet inhibition by ticagrelor was markedly greater than by clopidogrel in patients with ESRD on HD.
But exact mechanism of high platelet reactivity in ESRD patients was not fully evaluated.
A possible postulation would be genetic influence.
To investigate this issue, we will evaluate genetic polymorphism in patients with normal kidney function and ESRD on HD according to different doses of clopidogrel and ticagrelor.
Genetic test will be assessed polymorphism of ABCB1, PON1, CYP2C19, CYP2C9 and P2Y12.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Weon Kim, MD, PhD
- Phone Number: 82-2-958-8170
- Email: mylovekw@hanmail.net
Study Contact Backup
- Name: Jong Shin Woo, MD, PhD
- Phone Number: 82-2-958-8176
- Email: snowball77@hanmail.net
Study Locations
-
-
-
Seoul, Korea, Republic of, 130-872
- Recruiting
- Kyung Hee University Hospital
-
Contact:
- Weon Kim, MD, PhD
- Phone Number: 82 2-958-8170
- Email: mylovekw@hanmail.net
-
Contact:
- Jong Shin Woo, MD
- Phone Number: 82 2-958-8176
- Email: snowball77@hanmail.net
-
Sub-Investigator:
- Jong Shin Woo, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ESRD patients undergoing regular (≥ 6 months) maintenance HD
- Matching patients with normal kidney function
- documented coronary artery disease or high risk (Framingham heart risk score ≥ 20%) of coronary artery disease
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ticagrelor 180mg in ESRD patients
After randomization, ESRD patients on HD will be treated by an initial loading dose of ticagrelor (180 mg) and maintenance doses (ticagrelor 90 mg twice daily) for 14 days.
Platelet reactivity and genetic polymorphism will be assessed.
|
Patients with normal kidney function and ESRD on hemodialysis will be treated by ticagrelor 90mg twice a day for 14 days.
After then, platelet reactivity will be assessed by light aggregometry and VerifyNow assay.
Other Names:
|
Active Comparator: Clopidogrel 75mg in ESRD patients
After randomization, ESRD patients on HD will be treated by an initial loading dose of clopidogrel 300 mg) and maintenance doses (clopidogrel 75 mg once a day) for 14 days.
Platelet reactivity and genetic polymorphism will be assessed.
|
Patients with normal kidney function and ESRD on hemodialysis will be treated by clopidogrel 75mg or 150mg once a day for 14 days.
After then, platelet reactivity will be assessed by light aggregometry and VerifyNow assay.
Other Names:
|
Active Comparator: Clopidogrel 150mg in ESRD patients
After randomization, ESRD patients on HD will be treated by an initial loading dose of clopidogrel 300 mg) and maintenance doses (clopidogrel 150 mg once a day) for 14 days.
Platelet reactivity and genetic polymorphism will be assessed.
|
Patients with normal kidney function and ESRD on hemodialysis will be treated by clopidogrel 75mg or 150mg once a day for 14 days.
After then, platelet reactivity will be assessed by light aggregometry and VerifyNow assay.
Other Names:
|
Active Comparator: Ticagrelor 180mg in normal kidney
After randomization, patients with normal kidney function will be treated by an initial loading dose of ticagrelor (180 mg) and maintenance doses (ticagrelor 90 mg twice daily) for 14 days.
Platelet reactivity and genetic polymorphism will be assessed
|
Patients with normal kidney function and ESRD on hemodialysis will be treated by ticagrelor 90mg twice a day for 14 days.
After then, platelet reactivity will be assessed by light aggregometry and VerifyNow assay.
Other Names:
|
Active Comparator: Clopidogrel 75mg in normal kidney
After randomization, patients with normal kidney function will be treated by an initial loading dose of clopidogrel 300 mg) and maintenance doses (clopidogrel 75 mg once a day) for 14 days.
Platelet reactivity and genetic polymorphism will be assessed.
|
Patients with normal kidney function and ESRD on hemodialysis will be treated by clopidogrel 75mg or 150mg once a day for 14 days.
After then, platelet reactivity will be assessed by light aggregometry and VerifyNow assay.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The difference of antiplatelet effects according to genotype
Time Frame: 14 days after study drug treatment
|
The difference of P2Y12 reaction units (PRUs) according to genotype
|
14 days after study drug treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The difference of antiplatelet effects according to kidney function
Time Frame: 14 days after study drug treatment
|
The difference of P2Y12 reaction units (PRUs) according to kidney function
|
14 days after study drug treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Weon kim, MD, PhD, Kyung Hee University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Anticipated)
August 1, 2015
Study Completion (Anticipated)
August 1, 2015
Study Registration Dates
First Submitted
March 14, 2015
First Submitted That Met QC Criteria
March 19, 2015
First Posted (Estimate)
March 20, 2015
Study Record Updates
Last Update Posted (Estimate)
March 20, 2015
Last Update Submitted That Met QC Criteria
March 19, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urologic Diseases
- Renal Insufficiency
- Kidney Diseases
- Renal Insufficiency, Chronic
- 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
- Clopidogrel
Other Study ID Numbers
- PIANO-genetics
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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