Short vs Long Duration Dual Antiplatelet Therapy in Patients Undergoing Lower Extremity Endovascular Revascularization

Study Overview
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Brief Summary
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The primary objective of the trial is to evaluate short versus long duration dual antiplatelet therapy in patients undergoing lower extremity endovascular revascularization.

Official Title
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Evaluation of Short Versus Long Duration Dual Antiplatelet Therapy in Patients Undergoing Lower Extremity Endovascular Revascularization

Conditions
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Peripheral Arterial Disease, Endovascular Procedures

Intervention / Treatment
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* Drug: Aspirin
* Drug: Clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide signed informed consent before initiation of any study related procedures Be at least 18 years of age Successful percutaneous lower extremity (iliac and infrainguinal) endovascular revascularization (percutaneous transluminal angioplasty, and /or stent). At least 1 vessel run-off in segment distal to the intervention Rutherford Classification 2-5 that is unresponsive to medical therapy Exclusion Criteria: Acute limb ischemia Procedure includes device deployment that has specific FDA regulations for anticoagulation/anti-platelet medication regimen. Patient undergoing atherectomy procedure Intervention includes deployment of drug eluted stent Critical limb ischemia (Rutherford Classification 6) Thrombocytopenia: Platelet count <50k Liver disease (Childs-Pugh B or C) Existing need for on going clopidogrel therapy Proton Pump Inhibitor Use (If unable to be switched) Need for therapeutic anticoagulation Known hypercoagulable disorder Allergy or contraindication to aspirin or clopidogrel Pregnancy Patients enrolled in another investigational drug or device study within the past 30 days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short Term<br>The short term group will continue Aspirin 81mg and Clopidogrel 75mg for 1 month after the intervention. After that, they will continue Aspirin 81mg only. | Drug: Aspirin<br>* Patients will take Aspirin 81 mg<br>* Other names: Acetylsalicylic acid (ASA);Drug: Clopidogrel<br>* Patients will take Clopidogrel 75 mg<br>* Other names: Plavix;|
| Experimental: Long Term<br>The long term group will continue Aspirin 81mg and Clopidogrel 75mg for 6 months after the intervention. After this time, they will continue on Aspirin 81mg only. | Drug: Aspirin<br>* Patients will take Aspirin 81 mg<br>* Other names: Acetylsalicylic acid (ASA);Drug: Clopidogrel<br>* Patients will take Clopidogrel 75 mg<br>* Other names: Plavix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiovascular Event Rates | Stroke, Myocardial Infarction, Cardiovascular Death | 12 months post-intervention | 
| Major Adverse Limb Event Rates | Severe limb ischemia leading to a reintervention or major vascular amputation | 12 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Outcome | Assessed by Intermittent Claudication Questionnaire and Short Form-36 Health Survey | 12 Months post-intervention |