Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02335099 |
| Other study ID # |
17224 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 1/Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
December 2014 |
| Est. completion date |
June 2019 |
Study information
| Verified date |
May 2022 |
| Source |
University of Virginia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
