- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02406911
Ticagrelor and Anti-inflammatory Effects
March 30, 2015 updated by: Weon Kim, Kyunghee University Medical Center
Relationship of Dose of Ticagrelor and Anti-inflammatory Effect in Patients With End Stage Renal Disease on Hemodialysis: PIANO-6 Randomized Crossover Study
Antiplatelet treatment in patients with end stage renal disease (ESRD) on hemodialysis (HD) is still challenging because of bleeding and thrombotic complications.
The investigators hypothesized ticagrelor once daily dose would achieve tolerable antiplatelet effects compared with ticagrelor twice a day dose in ESRD patients on HD.
Study Overview
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.
The investigators 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 whether platelet reactivity during ticagrelor treatment is associated with endothelial function, platelet activation markers and inflammation status in ESRD patients on HD.
Additionally, the dose dependent effects of ticagrelor have been rarely evaluated.
Study Type
Interventional
Enrollment (Anticipated)
25
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
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Seoul, Korea, Republic of, 130-872
- Recruiting
- Kyung Hee University Hospital
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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
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-
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
- 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
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: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ticagrelor 90 mg
After randomization, an initial loading dose of ticagrelor (180 mg) was given and low dose ticagrelor (ticagrelor 90 mg once a day) was treated for 14 days.
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After randomization, each group will be treated as assigned dose of ticagrelor (ticagrelor 90mg once a day or 90mg twice a day) for 14 days.
After 1 week wash-out period, cross-over study will be performed
Other Names:
|
Active Comparator: Ticagrelor 180 mg
After randomization, an initial loading dose of ticagrelor (180 mg) was given and usual dose ticagrelor (ticagrelor 90 mg twice a day) was treated for 14 days.
|
After randomization, each group will be treated as assigned dose of ticagrelor (ticagrelor 90mg once a day or 90mg twice a day) for 14 days.
After 1 week wash-out period, cross-over study will be performed
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The difference of antiplatelet effects assessed by VerifyNow assay
Time Frame: 14 days after study drug treatment
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The difference of PRU values achieved following antiplatelet therapy
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14 days after study drug treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The difference of antiplatelet effects assessed by light aggregometry assay
Time Frame: 14 days after study drug treatment
|
The difference of IPA values achieved following antiplatelet therapy
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14 days after study drug treatment
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The difference of endothelial function assessed by forearm flow-mediated vasodilation (FMD) and peripheral arterial tonometry (PAT)
Time Frame: 14 days after study drug treatment
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The difference of endothelial functions achieved following antiplatelet therapy
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14 days after study drug treatment
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The difference of anti-inflammatory biomarkers
Time Frame: 14 days after study drug treatment
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The difference of hsCRP, CD40, P-selectin, and IL-6
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14 days after study drug treatment
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events
Time Frame: 6 weeks
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Adverse events such as bleeding
|
6 weeks
|
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
February 1, 2015
Primary Completion (Anticipated)
June 1, 2015
Study Completion (Anticipated)
August 1, 2015
Study Registration Dates
First Submitted
March 14, 2015
First Submitted That Met QC Criteria
March 30, 2015
First Posted (Estimate)
April 2, 2015
Study Record Updates
Last Update Posted (Estimate)
April 2, 2015
Last Update Submitted That Met QC Criteria
March 30, 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
Other Study ID Numbers
- PIANO6
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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