Clinical trial NCT02798913: Effects of Prolonged DAPT After Lower Extremity Percutaneous Transluminal Angioplasty (PTA) in Patients With LE-PAD
Official title: Effects of Prolonged Dual Antiplatelet Therapy With Clopidogrel Plus Acetylsalicylic Acid (ASA) After Percutaneous Lower Extremity Revascularization in Patients With Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Peripheral Artery Disease
Keywords: dual antiplatelet therapy
peripheral transluminal angioplasty
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2016-06-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Major Adverse Cardiovascular Events + incidence of Major Adverse Limb Events
timeFrame: 24 months post-PTA
Secondary outcomes:
measure: Incidence of minor and major bleedings according to the GUSTO classification
timeFrame: 24 months post-PTA
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Department of Advanced Biomedical Sciences, University of Naples "Federico II"
Study officials:
affiliation: Federico II University
name: Bruno Trimarco
role: STUDY_DIRECTOR
affiliation: Federico II University
name: Giovanni Esposito, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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