CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 54 enrolled
Drug / intervention
ticagrelor +1 moredrug
Likely dose
ticagrelor 90 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02335099
NCT02335099Phase 2Completed

Randomized, Placebo-controlled, Single Blind, Trial to Determine the Safety and Efficacy of Ticagrelor for Maintaining Patency of Arterio-Venous Fistulae Created for Hemodialysis

University of Virginia·interventional·Posted Jan 9, 2015·Updated Jun 8, 2022

In Brief

A Phase 2 clinical trial evaluating ticagrelor and Placebo for End Stage Renal Disease and Vascular Access Patency. Completed, enrolled 54 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAstraZeneca

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 9, 2015
Enrollment StartDec 1, 2014
Primary CompletionJun 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 11.5 years ago

Interventions

ticagrelordrug

ticagrelor 90 mg twice a day for 6 months

Placebodrug

1 pill twice a day for 6 months