Ticagrelor and Peripheral Arterial Disease

Phase 4

Terminated

• Conditions: Peripheral Arterial Disease
• Interventions: Procedure: Percutaneous Peripheral Intervention; Device: Optical Coherence Tomography; Other: Ankle Brachial Index; Other: Six minute walk distance; Drug: Aspirin + Ticagrelor; Drug: Aspirin

• Registration Number: NCT02407314
• Lead Sponsor: Arkansas Heart Hospital

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-03-18
• Study First Submitted QC: 2015-04-01
• Study First Posted: 2015-04-02
• Study Start: 2015-06
• Primary Completion: 2017-01-17
• Study Completion: 2017-01-17
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-09
• Last Update Posted: 2019-01-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Patients with lower extremity claudication and PAD due to significant SFA stenosis (>60%) or total occlusions (Rutherford 2-6) that affects the quality of life despite medical therapy.
• The presence of OCT identified clot in the Superficial Femoral Artery (SFA) following stent placement.
• Evidence of significant SFA disease involving the most symptomatic limb established by noninvasive vascular testing (ankle-brachial index [ABI] <0.9, toe brachial Index [TBI] of <0.6. If ABI>1.4, SFA systolic acceleration time >140 milliseconds); computed tomographic angiography, or magnetic resonance angiography confirming at least a 60% stenosis of the SFA.
• At least one non-treated Below The Knee (BTK) vessel patent
• Male and female outpatients 18 years of age.
• The only following devices may be used for the revascularization procedures: conventional balloons and bare metal stents (block randomization).
• Subject has been advised of the beneficial effects of smoking cessation and regular exercise but must not be in the process of changing their smoking status at the time of screening. Patients may resume or increase exercising as an effect of post procedurally improved lower limb perfusion.
• Peak Walking Time (PWT) limited only by claudication.
• Willingness to participate, documented by written informed consent.

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Exclusion Criteria

• Patients requiring dual anti-platelet drug treatment before start of study
• Planned amputation
• Use of atherectomy devices
• Hypersensitivity to acetylsalicylic acid, or ticagrelor. For ticagrelor, hypersensitivity reactions in the past include angioedema
• Patients with known bleeding disorders
• Patients with known active pathological bleeding
• Patients needing chronic oral anticoagulant maintenance therapy
• Patients with a history of intracranial hemorrhage at any time, GI bleed in the past 6 months, or major surgery within the past 30 days
• Ischemic stroke during the past 3 months
• Patients considered to be at risk of bradycardic events unless treated with a permanent pacemaker
• Target is a restenotic lesion or in-stent restenosis
• Any scheduled revascularization procedure requiring dual-anti-platelet therapy for more than one month
• Severe hypertension that may put the patient at risk, systolic greater than or equal to 180 and/or diastolic greater than or equal to 100
• Severe liver disease
• History of congestive heart failure with an Left Ventricular Ejection Fraction (LVEF) of less than 30%
• Concern for inability of the patient to comply with study procedures and/or follow up (eg, alcohol or drug abuse)
• Infra-popliteal disease involving the last remaining vessel (single run-off)
• Prior lower extremity revascularization within the past 30 days prior to enrollment
• Atherectomy of PAD
• EXCIPIENTS to ticagrelor hypersensitivity
• Known pregnancy, breast-feeding, or intend to become pregnant during the study period (all female patients 55 years and younger, without past history of hysterectomy must have a pregnancy test prior to peripheral intervention at baseline and at 6 months)
• Creatinine clearance < 30 mL/min

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aspirin only	Percutaneous Peripheral Intervention	Clopidogrel 75 mg + aspirin 81 mg for the first month followed by aspirin 81 mg alone for months 2-6 months post percutaneous peripheral intervention (PPI) intervention assessed by optical coherence tomography (OCT) ankle brachial index (ABI) and six minute walk distance.
Aspirin only	Optical Coherence Tomography	Clopidogrel 75 mg + aspirin 81 mg for the first month followed by aspirin 81 mg alone for months 2-6 months post percutaneous peripheral intervention (PPI) intervention assessed by optical coherence tomography (OCT) ankle brachial index (ABI) and six minute walk distance.
Aspirin only	Ankle Brachial Index	Clopidogrel 75 mg + aspirin 81 mg for the first month followed by aspirin 81 mg alone for months 2-6 months post percutaneous peripheral intervention (PPI) intervention assessed by optical coherence tomography (OCT) ankle brachial index (ABI) and six minute walk distance.
Aspirin only	Six minute walk distance	Clopidogrel 75 mg + aspirin 81 mg for the first month followed by aspirin 81 mg alone for months 2-6 months post percutaneous peripheral intervention (PPI) intervention assessed by optical coherence tomography (OCT) ankle brachial index (ABI) and six minute walk distance.
Aspirin + Ticagrelor	Percutaneous Peripheral Intervention	ticagrelor 90 mg bid + aspirin 81 mg for months 1-6 months post percutaneous peripheral intervention (PPI) intervention assessed by optical coherence tomography (OCT)ankle brachial index (ABI) and six minute walk distance.
Aspirin + Ticagrelor	Optical Coherence Tomography	ticagrelor 90 mg bid + aspirin 81 mg for months 1-6 months post percutaneous peripheral intervention (PPI) intervention assessed by optical coherence tomography (OCT)ankle brachial index (ABI) and six minute walk distance.
Aspirin + Ticagrelor	Ankle Brachial Index	ticagrelor 90 mg bid + aspirin 81 mg for months 1-6 months post percutaneous peripheral intervention (PPI) intervention assessed by optical coherence tomography (OCT)ankle brachial index (ABI) and six minute walk distance.
Aspirin + Ticagrelor	Six minute walk distance	ticagrelor 90 mg bid + aspirin 81 mg for months 1-6 months post percutaneous peripheral intervention (PPI) intervention assessed by optical coherence tomography (OCT)ankle brachial index (ABI) and six minute walk distance.
Aspirin + Ticagrelor	Aspirin + Ticagrelor	ticagrelor 90 mg bid + aspirin 81 mg for months 1-6 months post percutaneous peripheral intervention (PPI) intervention assessed by optical coherence tomography (OCT)ankle brachial index (ABI) and six minute walk distance.
Aspirin only	Aspirin	Clopidogrel 75 mg + aspirin 81 mg for the first month followed by aspirin 81 mg alone for months 2-6 months post percutaneous peripheral intervention (PPI) intervention assessed by optical coherence tomography (OCT) ankle brachial index (ABI) and six minute walk distance.

Primary Outcome Measures

Name	Time	Method
Change in the Intraluminal clot volume (in mm3)	At baseline and at 6 months	Intraluminal clot volume will be assessed by Optical Coherence Tomography using a Core Lab.
Change in the Intraluminal clot length (mm)	At baseline and at 6 months	Intraluminal clotlength will be assessed by Optical Coherence Tomography using a Core Lab.

Trial Locations

Locations (1)

Arkansas Heart Hospital; 🇺🇸 Little Rock, Arkansas, United States