Short vs Long Duration Dual Antiplatelet Therapy in Patients Undergoing Lower Extremity Endovascular Revascularization
NCT ID: NCT02433587
Last Updated: 2019-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2019-10-31
2023-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Aspirin
Patients will take Aspirin 81 mg
Clopidogrel
Patients will take Clopidogrel 75 mg
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.
Aspirin
Patients will take Aspirin 81 mg
Clopidogrel
Patients will take Clopidogrel 75 mg
Interventions
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Aspirin
Patients will take Aspirin 81 mg
Clopidogrel
Patients will take Clopidogrel 75 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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University Hospitals Cleveland Medical Center
OTHER
Responsible Party
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Vikram S. Kashyap, M.D.
Chief, Division of Vascular Surgery & Endovascular Therapy
Locations
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University Hospitals Case Medical Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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08-14-29
Identifier Type: -
Identifier Source: org_study_id
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