Phase 2 Completed N=44 Randomized Single-blind Treatment

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

End Stage Renal Disease · Vascular Access Patency

Source: ClinicalTrials.gov NCT02335099 ↗

Enrolled (actual)

Serious AEs

5.9%

Results posted

Jun 2022

Primary outcomePrimary: Feasibility and Safety of Ticagrelor in Hemodialysis Patients — 1; 3 Participants — p=0.32

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Feasibility and Safety of Ticagrelor in Hemodialysis Patients	1; 3	0.32
SECONDARY Treatment Efficacy of Ticagrelor to Preserve Patency of Hemodialysis Vascular Access	72.2; 75.0	0.82

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02335099). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.