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Ticagrelor and Peripheral Arterial Disease

Peripheral Arterial Disease Clinical Trial

Official title:
Impact of Ticagrelor and Aspirin Versus Clopidogrel and Aspirin in Patients With Claudication and Peripheral Arterial Disease (PAD): Thrombus Burden Assessed by Optical Coherence Tomography

Clinical Trial Summary

This is an interventional study assessing the effectiveness of Ticagrelor on the reduction of thrombus burden using optical coherence tomography in patients undergoing peripheral artery stenting.

Clinical Trial Description

Prospective, randomized study, comparing ticagrelor + aspirin vs. aspirin monotherapy following the 4-week post-procedural combination of Ticagrelor or Plavix with low dose aspirin. The investigators will enroll a minimum of 40 patients. Patients will be enrolled if they have either claudication and/or critical limb ischemia, and angiographically identified superficial femoral artery (SFA) disease requiring intervention, with either total occlusion or a significant SFA stenosis with the presence of Optical Coherence Tomography (OCT) defined clot following stent placement.

Participants will be evaluated at baseline, 1 month, 4 months, 6 and 7 months following SFA intervention. At baseline demographic data will be collected, and anthropomorphic and physiological variables (body mass index, waist circumference, blood pressure). Baseline and 6-month ankle brachial index (ABI) will be performed. A 6-min walk test will be performed at baseline and 6-month follow-up. At 6 month time point patients in both treatment groups will return for a peripheral angiogram and repeat OCT imaging of the SFA segments of interest. Subject will have a final follow up clinic visit at 7 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02407314
Study type Interventional
Source Arkansas Heart Hospital
Contact
Status Terminated
Phase Phase 4
Start date June 2015
Completion date January 17, 2017
View Details
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