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

NCT02762864 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2016-05-05

No results posted yet for this study

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.

Conditions

Interventions

OTHER

platelet (P2Y12) reaction units

VerifyNow P2Y12 assay point-of-care testing

DRUG

ticagrelor

Antiplatelet therapy approved for ACS. Antagonist of P2Y12 and inhibitor of adenosine diphosphate (ADP)-induced platelet aggregation.

DRUG

Comparator

dual antiplatelet therapy with clopidogrel 75 mg and aspirin 100 mg daily will be continued for 6 months after the procedure for patient followed with single antiplatelet therapy with clopidogrel 75 mg daily throughout the follow-up period.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Chi-Hsiao Yeh, MD pHD · Chang Gung Memorial Hospital, Keeln\ung

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2019-04-30
Completion
2019-04-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02762864 on ClinicalTrials.gov