drugset / Trial / NCT02762864

Post-operative Treatment of Diabetic Peripheral Arterial Disease Guided by Platelet Reactivity Unit

NCT02762864

Unknown 200 enrolled Chang Gung Memorial Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

To compare the effect of PRU(platelet (P2Y12) reaction units)-guided treatment on the change in 1. time of initial leg pain and time of termination of exercise test by pain, evaluated on the graded stationary bicycle test, 2. the lower limb perfusion by using MRI blood oxygenation-level dependent (BOLD) and dynamic contrast enhancement sequences and measures the extracellular volume fraction (ECV) as an indicator of fibrosis severity in calf muscles, from one to 52 weeks post-revascularization in patients with peripheral artery disease who have undergone endovascular revascularization -/+ bypass surgery for moderate to severe claudication or ischemic rest pain.

Timeline

Start
2016-05
Primary completion
2019-04
Completion
2019-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Ticagrelor Small molecule
Background Aspirin Small molecule 100 mg
Background Clopidogrel Small molecule 75 mg