NCT02762864

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients will be randomly assigned to PRU-guided and non-PRU-guided group. In the non-PRU -target group, 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. In the PRU-target group, dual antiplatelet therapy will be the same protocol as in the non-PRU-target group for patients with PRU \<234 seconds. However, for patients in the PRU-target group with PRU ≥234 seconds, rescue medicine will be added to keep PRU\<234 seconds.

Conditions

• Peripheral Artery Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-05-01
• Primary completion: 2019-04-01
• Completion: 2019-04-01
• First posted: 2016-05-05
• Last updated: 2016-05-05