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

Phase 3

• Conditions: Peripheral Artery Disease
• Interventions: Drug: Short DAPT; Drug: Long DAPT

• Registration Number: NCT02798913
• Lead Sponsor: Federico II University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-06-09
• Study First Submitted QC: 2016-06-09
• Study First Posted: 2016-06-14
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-13
• Last Update Posted: 2019-02-15
• Primary Completion: 2020-06
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short DAPT	Short DAPT	Patients who will be treated after PTA with acetylsalicylic acid 100 mg/day life-long + clopidogrel 75 mg/day for 3 months
Long DAPT	Long DAPT	Patients who will be treated after PTA with acetylsalicylic acid 100 mg/day life-long + clopidogrel 75 mg/day for 12 months

Primary Outcome Measures

Name	Time	Method
Incidence of Major Adverse Cardiovascular Events + incidence of Major Adverse Limb Events	24 months post-PTA	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).

Secondary Outcome Measures

Name	Time	Method
Incidence of minor and major bleedings according to the GUSTO classification	24 months post-PTA	Incidence of minor and major bleedings according to the Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries classification

Trial Locations

Locations (1)

Department of Advanced Biomedical Sciences, University of Naples "Federico II"; 🇮🇹 Naples, Italy