Effects of Prolonged DAPT After Lower Extremity Percutaneous Transluminal Angioplasty (PTA) in Patients With LE-PAD

Study Overview
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Brief Summary
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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).

Official Title
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Effects of Prolonged Dual Antiplatelet Therapy With Clopidogrel Plus Acetylsalicylic Acid (ASA) After Percutaneous Lower Extremity Revascularization in Patients With Peripheral Arterial Disease

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Drug: Short DAPT
* Drug: Long DAPT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: LE-PAD at stage 2 of Fontaine's classification (intermittent claudication) successful PTA of aorto-iliac, femoro-popliteal ore below-the-knee segments Exclusion Criteria: critical limb ischemia recent acute coronary syndrome (< 12 months) recent cerebrovascular event (< 12 months) recent myocardial, carotid or peripheral revascularization (< 12 months) recent history of bleeding (< 12 months) other indication for clopidogrel therapy indication for anticoagulation de-compensated heart failure malignant neoplasm

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short DAPT<br>Patients who will be treated after PTA with acetylsalicylic acid 100 mg/day life-long + clopidogrel 75 mg/day for 3 months | Drug: Short DAPT<br>* acetylsalicylic acid 100 mg/day life-long + clopidogrel 75 mg/day for 3 months<br>* Other names: 3 months ASA + Clopidogrel;|
| Experimental: Long DAPT<br>Patients who will be treated after PTA with acetylsalicylic acid 100 mg/day life-long + clopidogrel 75 mg/day for 12 months | Drug: Long DAPT<br>* acetylsalicylic acid 100 mg/day life-long + clopidogrel 75 mg/day for 12 months<br>* Other names: 12 months ASA + Clopidogrel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence 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). | 24 months post-PTA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 24 months post-PTA | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dual antiplatelet therapy, peripheral transluminal angioplasty