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Ticagrelor and Anti-inflammatory Effects

Primary Purpose

Chronic Kidney Disease

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ticagrelor
Sponsored by
Kyunghee University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ticagrelor 90 mg

Ticagrelor 180 mg

Arm Description

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.

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.

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 difference of antiplatelet effects assessed by light aggregometry assay
The difference of IPA values achieved following antiplatelet therapy
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
The difference of anti-inflammatory biomarkers
The difference of hsCRP, CD40, P-selectin, and IL-6

Full Information

First Posted
March 14, 2015
Last Updated
March 30, 2015
Sponsor
Kyunghee University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02406911
Brief Title
Ticagrelor and Anti-inflammatory Effects
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyunghee University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

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
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ticagrelor 90 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Ticagrelor 180 mg
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Other Intervention Name(s)
Ticagrelor (Brilinta)
Intervention Description
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
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 difference of antiplatelet effects assessed by light aggregometry assay
Description
The difference of IPA values achieved following antiplatelet therapy
Time Frame
14 days after study drug treatment
Title
The difference of endothelial function assessed by forearm flow-mediated vasodilation (FMD) and peripheral arterial tonometry (PAT)
Description
The difference of endothelial functions achieved following antiplatelet therapy
Time Frame
14 days after study drug treatment
Title
The difference of anti-inflammatory biomarkers
Description
The difference of hsCRP, CD40, P-selectin, and IL-6
Time Frame
14 days after study drug treatment
Other Pre-specified Outcome Measures:
Title
Adverse events
Description
Adverse events such as bleeding
Time Frame
6 weeks

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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weon Kim, MD, PhD
Phone
82-2-958-8170
Email
mylovekw@hanmail.net
First Name & Middle Initial & Last Name or Official Title & Degree
Jong Shin Woo, MD, PhD
Phone
82-2-958-8176
Email
snowball77@hanmail.net
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
130-872
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weon Kim, MD, PhD
Phone
2-958-8170
Ext
82
Email
mylovekw@hanmail.net
First Name & Middle Initial & Last Name & Degree
Jong Shin Woo, MD
Phone
2-958-8176
Ext
82
Email
snowball77@hanmail.net
First Name & Middle Initial & Last Name & Degree
Jong Shin Woo, MD

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

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Ticagrelor and Anti-inflammatory Effects

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