Evaluation of Short Versus Long Duration Dual Antiplatelet Therapy in Patients Undergoing Lower Extremity Endovascular Revascularization
Status: | Not yet recruiting |
---|---|
Conditions: | Peripheral Vascular Disease |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/17/2016 |
Start Date: | July 2016 |
End Date: | July 2020 |
Contact: | Vikram Kashyap, MD |
Email: | vikram.kashyap@uhhospitals.org |
Phone: | 216-844-3013 |
The primary objective of the trial is to evaluate short versus long duration dual
antiplatelet therapy in patients undergoing lower extremity endovascular revascularization.
antiplatelet therapy in patients undergoing lower extremity endovascular revascularization.
Inclusion Criteria:
1. Provide signed informed consent before initiation of any study related procedures
2. Be at least 18 years of age
3. Successful percutaneous lower extremity (iliac and infrainguinal) endovascular
revascularization (percutaneous transluminal angioplasty, and /or stent).
4. At least 1 vessel run-off in segment distal to the intervention
5. Rutherford Classification 2-5 that is unresponsive to medical therapy
Exclusion Criteria:
1. Acute limb ischemia
2. Procedure includes device deployment that has specific FDA regulations for
anticoagulation/anti-platelet medication regimen.
3. Patient undergoing atherectomy procedure
4. Intervention includes deployment of drug eluted stent
5. Critical limb ischemia (Rutherford Classification 6)
6. Thrombocytopenia: Platelet count <50k
7. Liver disease (Childs-Pugh B or C)
8. Existing need for on going clopidogrel therapy
9. Proton Pump Inhibitor Use (If unable to be switched)
10. Need for therapeutic anticoagulation
11. Known hypercoagulable disorder
12. Allergy or contraindication to aspirin or clopidogrel
13. Pregnancy
14. Patients enrolled in another investigational drug or device study within the past 30
days
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