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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02406911
Other study ID # PIANO6
Secondary ID
Status Recruiting
Phase Phase 3
First received March 14, 2015
Last updated March 30, 2015
Start date February 2015
Est. completion date August 2015

Study information

Verified date March 2015
Source Kyunghee University Medical Center
Contact Weon Kim, MD, PhD
Phone 82-2-958-8170
Email mylovekw@hanmail.net
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Intervention

Drug:
Ticagrelor
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

Locations

Country Name City State
Korea, Republic of Kyung Hee University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Kyunghee University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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
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