Evaluation of Short Versus Long Duration Dual Antiplatelet Therapy in Patients Undergoing Lower Extremity Endovascular Revascularization
Overview
- Phase
- Phase 3
- Intervention
- Aspirin
- Conditions
- Peripheral Arterial Disease
- Sponsor
- University Hospitals Cleveland Medical Center
- Locations
- 1
- Primary Endpoint
- Major Adverse Limb Event Rates
- Status
- Withdrawn
- Last Updated
- 6 years ago
Overview
Brief Summary
The primary objective of the trial is to evaluate short versus long duration dual antiplatelet therapy in patients undergoing lower extremity endovascular revascularization.
Investigators
Vikram S. Kashyap, M.D.
Chief, Division of Vascular Surgery & Endovascular Therapy
University Hospitals Cleveland Medical Center
Eligibility Criteria
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
Arms & Interventions
Short Term
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.
Intervention: Aspirin
Short Term
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.
Intervention: Clopidogrel
Long Term
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.
Intervention: Aspirin
Long Term
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.
Intervention: Clopidogrel
Outcomes
Primary Outcomes
Major Adverse Limb Event Rates
Time Frame: 12 months post-intervention
Severe limb ischemia leading to a reintervention or major vascular amputation
Major Adverse Cardiovascular Event Rates
Time Frame: 12 months post-intervention
Stroke, Myocardial Infarction, Cardiovascular Death
Secondary Outcomes
- Quality of Life Outcome(12 Months post-intervention)