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

Status

Unknown

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. 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

Study Contact Backup

Study Locations

      • Seoul, Korea, Republic of, 130-872
        • Recruiting
        • Kyung Hee University Hospital
        • Contact:
        • Contact:
        • 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
  • 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.
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:
  • Ticagrelor (Brilinta)
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:
  • Ticagrelor (Brilinta)

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
The difference of PRU values achieved following antiplatelet therapy
14 days after study drug treatment

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
14 days after study drug treatment
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
The difference of endothelial functions achieved following antiplatelet therapy
14 days after study drug treatment
The difference of anti-inflammatory biomarkers
Time Frame: 14 days after study drug treatment
The difference of hsCRP, CD40, P-selectin, and IL-6
14 days after study drug treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 6 weeks
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

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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