CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 70 enrolled
Drug / intervention
Aspirin +3 moredrug
Likely dose
Aspirin 81mgfrom 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/NCT02325466
NCT02325466Phase 3Completed

Comparative Efficacy of Ticagrelor Versus Aspirin on Blood Viscosity in Peripheral Artery Disease (PAD) Patients With Type 2 Diabetes (T2D)

Icahn School of Medicine at Mount Sinai·interventional·Posted Dec 25, 2014·Updated Mar 21, 2022

In Brief

A Phase 3 clinical trial evaluating Aspirin, Ticagrelor, and 2 other interventions for Peripheral Artery Disease and Type 2 Diabetes. Completed, enrolled 70 participants across 1 site.

Detailed Summary

The hypothesis being that both aspirin-ticagrelor and ticagrelor monotherapy will be superior to aspirin monotherapy in the reduction of whole blood viscosity at the end of each 4 week treatment period. Study participants will be randomized into 3 groups, and each group will receive each of 3 treatments in the cross-over study. At the end of each individual 4 week treatment period the investigators will determine whether there are differences in low and high shear rate dependent viscosity and investigate the effect of the treatment on peripheral arterial blood flow using pulse volume recordings, ankle brachial index and toe pressures. Subjects will be eligible if they have ankle-brachial index less than or equal to 0.85, or if a patient's blood vessels are calcified, patients will have toe-brachial index less than or equal to 0.6 performed using continuous-wave Doppler.

Study Details

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

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 25, 2014
Enrollment StartApr 1, 2015
Primary CompletionMay 4, 2018
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 11.5 years ago

Interventions

Aspirindrug

Aspirin 81mg

Ticagrelordrug

ticagrelor 90 mg

Aspirin Placebodrug

Ticagrelor Placebodrug