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

• Status: Withdrawn
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center
• Treatments: Aspirin; Clopidogrel

Criteria

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