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

NCT ID: NCT02335099

Last Updated: 2022-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2019-06-30

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.

Conditions

End Stage Renal Disease; Vascular Access Patency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ticagrelor

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

Group Type: ACTIVE_COMPARATOR

ticagrelor

Intervention Type: DRUG

ticagrelor 90 mg twice a day for 6 months

Placebo

Placebo drug to be given twice a day for 6 months

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

1 pill twice a day for 6 months

Interventions

ticagrelor

ticagrelor 90 mg twice a day for 6 months

Intervention Type: DRUG

Placebo

1 pill twice a day for 6 months

Intervention Type: DRUG

Other Intervention Names

Brilinta

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Emaad Abdel-Rahman, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Virginia - Hospital West Kidney Center Dialysis

Charlottesville, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

17224

Identifier Type: -

Identifier Source: org_study_id