Antiplatelet Strategy for Peripheral Arterial Interventions for Revascularization of Lower Extremities
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Intervention: Clopidogrel; Acetylsalicylic acid (ASA)
Intervention description: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration + 12 months; Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration + 12 months
Intervention MeSH terms: Aspirin; Clopidogrel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 159.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: peripheral arterial disease, antiplatelet therapy

Summary:

      The purpose of this study is to evaluate whether clopidogrel 75 mg daily on a background of
      aspirin 75-100 mg/d for clinically indicated duration or for an additional 12 months will
      lead to an increased rate of primary patency, limb salvage, non-fatal myocardial infarction
      (MI), ischemic stroke, and survival, in patients receiving endovascular treatment of PAD at
      end of study treatment.
    

Eligibility criteria:

        Inclusion Criteria:

        General:

          -  Signed informed consent

          -  At least 18 years old

          -  Documented symptomatic iliac, femoropopliteal (FP) or below-the knee artery (BTK)
             atherosclerotic disease (Rutherford/Becker category 2, 3 or ≥4)

          -  Undergone clinically indicated uncomplicated endovascular intervention to one or more
             locations of the iliac, femoropopliteal below-the knee arteries

          -  Estimated survival ≥1 year in the judgment of the primary operator

          -  Pre-index procedure use of ASA, clopidogrel or both at any dose

        Angiographic:

          -  De novo or restenotic lesions in the common and/or external iliac artery, superficial
             femoral artery (SFA), popliteal artery, tibio-peroneal (TP) trunk, anterior tibial
             (AT) artery, peroneal artery (PA) or posterior tibial (PT) artery (applies to all
             target lesions if multiple)

          -  Subjects with multiple planned procedures can be enrolled after the completion of the
             last planned procedure.

        Exclusion Criteria:

        General:

          -  Complicated qualifying procedure (perforation, flow limiting dissection, distal
             embolization requiring re-intervention, need for repeat endovascular, surgical
             revascularization, amputation or blood transfusion prior to hospital discharge
             following an index procedure

          -  Extended hospital stay >7 days following the index procedure

          -  Allergy to aspirin or clopidogrel

          -  Life expectancy less than 12 months due to other medical co-morbid condition(s) that
             could limit the subject's ability to participate in the trial, limit the subject's
             compliance with the follow-up requirements, or impact the scientific integrity of the
             trial

          -  Known hypersensitivity or contraindication to contrast dye that, in the opinion of the
             investigator, cannot be adequately pre-medicated.

          -  Intolerance to antiplatelet, anticoagulant, or thrombolytic medications

          -  Platelet count <90,000 mm3 or >600,000 mm3

          -  Serum creatinine >2.5 mg/dL

          -  Dialysis-dependent end stage renal disease

          -  Pregnancy

          -  Current participation in another drug or device trial that requires interruption of
             dual-antiplatelet therapy with aspirin or clopidogrel for the duration of the study

          -  Planned surgeries, endovascular or other non-vascular or cardiac procedures

          -  Concurrent warfarin or other chronic oral anticoagulant therapy

          -  Contraindication(s) to the use of AT (history of intra-cerebral bleed, presence of
             intra-cerebral mass, recent or <6 weeks gastrointestinal bleed, blood transfusion
             within the last 6 weeks, any trauma requiring surgery or blood transfusion within the
             last 4 weeks or any surgical procedure within the last 4 weeks.

        Angiographic:

          -  Endovascular intervention to iliac, femoropopliteal or BTK artery bypass graft

          -  Persistent, intraluminal thrombus of the proposed target lesion at the completion of
             the index procedure

          -  Perforated vessel as evidenced by extravasation of contrast media

          -  Vascular graft, aneurysm or postsurgical stenosis of the target vessel