Antiplatelet Strategy for Peripheral Arterial Interventions for Revascularization of Lower Extremities
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      Peripheral arterial disease (PAD) is extremely prevalent worldwide and affects over 206
      million people. Over 36 million patients with PAD are estimated to be present in the United
      States. Percutaneous revascularization therapies have evolved dramatically, yet the long-term
      success of these therapies remains modest and the morbidity and mortality associated with PAD
      remains high, with up to 30% mortality risk at 5 years. Nearly, 3.2 million endovascular
      procedures are performed annually. Though, this exceeds interventional procedures performed
      for coronary artery disease (CAD), the current PAD guidelines are silent regarding the need
      and optimal duration of antiplatelet therapy (APT) for patients following an endovascular
      procedure for claudication or critical limb ischemia (CLI). The lack of data and clinical
      studies is by far the greatest impediment to the formulation of such guideline
      recommendations critically needed by providers and patients alike, especially given the
      current limited durability of lower extremity endovascular procedures.

      The objective of this trial is to evaluate whether clopidogrel 75 mg QD on a background of
      ASA 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.

      The investigators hypothesize that dual antiplatelet therapy (DAPT) with ASA and clopidogrel
      administered for an additional 12 months following iliac, femoropopliteal or below the knee
      endovascular intervention will improve primary patency, limb salvage, freedom from ischemic
      stroke and survival, in patients with symptomatic PAD.

      Clinical endpoints will be analyzed in all subjects who are enrolled, regardless of whether
      the trial treatment administered successfully completed for the desired duration. A subject
      will be considered enrolled in the trial when he/she is randomized to one of the treatment
      arms of the study. All endpoints are subject-based unless otherwise specified.

      The primary endpoint is subject-based of the longer of a 12-month or end of study treatment
      endpoint of the first occurrence of index limb arterial occlusion, surgical intervention,
      endovascular intervention, amputation of the affected limb (primary patency and limb
      salvage), MI, ischemic stroke or death (survival).

      The secondary endpoints are subject-based on the longer of a 12 month or end of study
      treatment endpoints that include: (a) the first occurrence of any individual component of the
      primary endpoint, (b) the first occurrence of the following during follow-up: cardiovascular
      death, or MI, or ischemic stroke, or any amputation above the ankle and (c) severe bleeding
      defined according to the Global Utilization of Streptokinase and Tissue plasminogen activator
      for Occluded coronary arteries (GUSTO) classification.

      The tertiary endpoint is based on the longer of a 12-month or end of study moderate bleeding
      according to the GUSTO classification.
    

Intervention name(s): Clopidogrel; Acetylsalicylic acid (ASA)
Intervention type(s): Drug; Drug
Intervention description(s): 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
Other intervention name(s): Plavix; Aspirin
Intervention MeSH terms: Aspirin; Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: peripheral arterial disease, antiplatelet therapy