Chronic Kidney Disease Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 25 |
Est. completion date | August 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Kyung Hee University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Kyunghee University Medical Center |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse events | Adverse events such as bleeding | 6 weeks | Yes |
Primary | The difference of antiplatelet effects assessed by VerifyNow assay | The difference of PRU values achieved following antiplatelet therapy | 14 days after study drug treatment | Yes |
Secondary | The difference of antiplatelet effects assessed by light aggregometry assay | The difference of IPA values achieved following antiplatelet therapy | 14 days after study drug treatment | Yes |
Secondary | The difference of endothelial function assessed by forearm flow-mediated vasodilation (FMD) and peripheral arterial tonometry (PAT) | The difference of endothelial functions achieved following antiplatelet therapy | 14 days after study drug treatment | Yes |
Secondary | The difference of anti-inflammatory biomarkers | The difference of hsCRP, CD40, P-selectin, and IL-6 | 14 days after study drug treatment | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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