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

University Hospitals (UH)

Status and phase: Withdrawn; Phase 3

Conditions: Peripheral Arterial Disease; Endovascular Procedures

Treatments: Drug: Clopidogrel; Drug: Aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT02433587

08-14-29

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Short Term

Experimental group

Description:

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.

Treatment:

Drug: Aspirin

Drug: Clopidogrel

Long Term

Experimental group

Description:

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.

Treatment:

Drug: Aspirin

Drug: Clopidogrel