Determine the Safety/Efficacy of Ticagrelor for Maintaining Patency of Arterio-Venous Fistulae Created for Hemodialysis
Condition: End Stage Renal Disease; Vascular Access Patency
MeSH terms: Kidney Failure, Chronic; Arteriovenous Fistula; Fistula
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Intervention name(s): ticagrelor; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ticagrelor 90 mg twice a day for 6 months; 1 pill twice a day for 6 months
Other intervention name(s): Brilinta
Intervention MeSH terms: Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: hemodialysis; vascular access; vascular access patency; ticagrelor; brilinta