The objective of the present study was to evaluate the prognostic impact of prolonged dual antiplatelet therapy (DAPT) with acetylsalicylic acid plus clopidogrel on the incidence of major adverse cardiovascular events and major adverse limb events after percutaneous lower extremity revascularization in patients with lower extremity peripheral arterial disease (LE-PAD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
acetylsalicylic acid 100 mg/day life-long + clopidogrel 75 mg/day for 3 months
acetylsalicylic acid 100 mg/day life-long + clopidogrel 75 mg/day for 12 months
Department of Advanced Biomedical Sciences, University of Naples "Federico II"
Naples, Italy
RECRUITINGIncidence of Major Adverse Cardiovascular Events + incidence of Major Adverse Limb Events
Impact of prolonged vs. short dual antiplatelet therapy after PTA on the incidence of major adverse cardiovascular events (death from cardiovascular cause, myocardial infarction, stroke, coronary or carotid revascularization) + the incidence of major adverse limb events (restenosis, occlusion, or new revascularization of target lesion, new stenosis, occlusion, or revascularization of not-target lesion, onset of acute and critical limb ischemia, amputation).
Time frame: 24 months post-PTA
Incidence of minor and major bleedings according to the GUSTO classification
Incidence of minor and major bleedings according to the Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries classification
Time frame: 24 months post-PTA
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