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Determine the Safety/Efficacy of Ticagrelor for Maintaining Patency of Arterio-Venous Fistulae Created for Hemodialysis

Primary Purpose

End Stage Renal Disease, Vascular Access Patency

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ticagrelor
Placebo
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring hemodialysis, vascular access, vascular access patency, ticagrelor, brilinta

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Patients on chronic hemodialysis with a functioning arterio-venous fistula

Exclusion Criteria:

  • Recent history of bleeding over the last 3 months preceding enrollment
  • History of bleeding disorder (hemophilia, Von Willebrandt disease, etc….)
  • Recent history of blood transfusion over the last 3 months preceding enrollment
  • Recent serious injury or surgery over the last 3 months preceding enrollment
  • History of gastro-intestinal ulcers
  • Moderate-severe hepatic impairment
  • Uncontrolled blood pressure (SBP> 200 or DBP >110) post dialysis
  • History of stroke
  • Pregnant females-self reported
  • Hypersensitivity to Aspirin /antiplatelets
  • Subjects using peroral anticoagulants

Sites / Locations

  • University of Virginia - Hospital West Kidney Center Dialysis

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ticagrelor

Placebo

Arm Description

90 mg of ticagrelor to be given orally twice a day for 6 months

Placebo drug to be given twice a day for 6 months

Outcomes

Primary Outcome Measures

Feasibility and Safety of Ticagrelor in Hemodialysis Patients
Number of Participants with prolonged bleeding (>30 minutes) after removal of needles

Secondary Outcome Measures

Treatment Efficacy of Ticagrelor to Preserve Patency of Hemodialysis Vascular Access
Percentage of participants with stenosis free survival

Full Information

First Posted
December 19, 2014
Last Updated
May 13, 2022
Sponsor
University of Virginia
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT02335099
Brief Title
Determine the Safety/Efficacy of Ticagrelor for Maintaining Patency of Arterio-Venous Fistulae Created for Hemodialysis
Official Title
Randomized, Placebo-controlled, Single Blind, Trial to Determine the Safety and Efficacy of Ticagrelor for Maintaining Patency of Arterio-Venous Fistulae Created for Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
June 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is a randomized, placebo-controlled, single blind clinical trial. Seventy patients with ESRD on chronic HD and a functioning AVF will be recruited. The following data will be documented on each patient: 1-Age/gender/race/body weight/cause of ESRD 2-Vintage of HD 3-Time since access was placed 4-Type and place of access and blood flow rate of access 5-History of prior access problems 6-Comorbid conditions (Hypertension, coronary artery disease, Diabetes Mellitus, Bleeding problems, peripheral vascular disease). 7-Current medications (Coumadin, Erythropoiesis stimulating agents, heparin, other antiplatelets, digoxin, statins). Patients will be randomized into two groups to receive: Group 1: Ticagrelor 90 mg PO BID Group 2: Placebo drug PO BID.
Detailed Description
This study is a randomized, placebo-controlled, single blind clinical trial. Seventy patients with ESRD on chronic HD and a functioning AVF will be recruited. Consent form will be obtained. History and physical, dialysis parameters and laboratory data (CBC, CMP, PTT & INR) will be obtained throughout the study. The following data will be documented on each patient: 1-Age/gender/race/body weight/cause of ESRD 2-Vintage of HD 3-Time since access was placed 4-Type and place of access and blood flow rate of access 5-History of prior access problems 6-Comorbid conditions (Hypertension, coronary artery disease, Diabetes Mellitus, Bleeding problems, peripheral vascular disease). 7-Current medications (Coumadin, Erythropoiesis stimulating agents, heparin, other antiplatelets, digoxin, statins). Patients will be randomized into two groups to receive: Group 1: Ticagrelor 90 mg PO BID Group 2: Placebo drug PO BID. Subjects will have a screening visit and if they qualify for the study they will have 18 additional visits. All of these visits will occur while the subjects are at their normal dialysis treatment. Subjects will be randomized to either the Ticagrelor group or the placebo group. Subjects will be on study medication for 6 months then they will have a follow up period off drug for 6 months. Subjects will be seen twice a month while on study medication and once a month in the follow up period. While the subjects are on study medication the study team will assess any side effects of the study medication and put their relation to the study drug at each study visit. The study team will use clinical monitoring as suggested by Beathard (21). The study team will document the subject's adherence to the study, if they are hospitalized and what caused their hospitalization. A monthly intra-access flow will be obtained using ultrasound dilution by transonics as part of standard of care. Any change in the clinical assessment of the access, prolonged bleeding (>20 minutes) after removal of needles, trend of decreasing intra-access blood flow as determined by transonic (> 25% or original flow), or an access flow rate < 400 ml/min, will prompt a referral for a fistulogram. If confirmed stenosis (>50% stenosis of the access diameter) an intervention (angioplasty) will be performed. This intervention is part of the subjects standard of care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Vascular Access Patency
Keywords
hemodialysis, vascular access, vascular access patency, ticagrelor, brilinta

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ticagrelor
Arm Type
Active Comparator
Arm Description
90 mg of ticagrelor to be given orally twice a day for 6 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo drug to be given twice a day for 6 months
Intervention Type
Drug
Intervention Name(s)
ticagrelor
Other Intervention Name(s)
Brilinta
Intervention Description
ticagrelor 90 mg twice a day for 6 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 pill twice a day for 6 months
Primary Outcome Measure Information:
Title
Feasibility and Safety of Ticagrelor in Hemodialysis Patients
Description
Number of Participants with prolonged bleeding (>30 minutes) after removal of needles
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Treatment Efficacy of Ticagrelor to Preserve Patency of Hemodialysis Vascular Access
Description
Percentage of participants with stenosis free survival
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Patients on chronic hemodialysis with a functioning arterio-venous fistula Exclusion Criteria: Recent history of bleeding over the last 3 months preceding enrollment History of bleeding disorder (hemophilia, Von Willebrandt disease, etc….) Recent history of blood transfusion over the last 3 months preceding enrollment Recent serious injury or surgery over the last 3 months preceding enrollment History of gastro-intestinal ulcers Moderate-severe hepatic impairment Uncontrolled blood pressure (SBP> 200 or DBP >110) post dialysis History of stroke Pregnant females-self reported Hypersensitivity to Aspirin /antiplatelets Subjects using peroral anticoagulants
Facility Information:
Facility Name
University of Virginia - Hospital West Kidney Center Dialysis
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Determine the Safety/Efficacy of Ticagrelor for Maintaining Patency of Arterio-Venous Fistulae Created for Hemodialysis

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