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

NCT02798913 | Unknown Phase 3

• 1 other identifier: 103/13
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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).

Conditions

Peripheral Artery Disease

Keywords

dual antiplatelet therapy; peripheral transluminal angioplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of minor and major bleedings according to the GUSTO classification

  24 months post-PTA

Study Arms (2)

Short DAPT

EXPERIMENTAL

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

Long DAPT

EXPERIMENTAL

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

Interventions

Short DAPT DRUG

acetylsalicylic acid 100 mg/day life-long + clopidogrel 75 mg/day for 3 months

Also known as: 3 months ASA + Clopidogrel

Short DAPT

Long DAPT DRUG

acetylsalicylic acid 100 mg/day life-long + clopidogrel 75 mg/day for 12 months

Also known as: 12 months ASA + Clopidogrel

Long DAPT

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• LE-PAD at stage 2 of Fontaine's classification (intermittent claudication)
• successful PTA of aorto-iliac, femoro-popliteal ore below-the-knee segments

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Department of Advanced Biomedical Sciences, University of Naples "Federico II"

Naples, 80131, Italy

RECRUITING

Related Publications (17)

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MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Bruno Trimarco

  Federico II University

  STUDY DIRECTOR

• Giovanni Esposito, MD, PhD

  Federico II University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Giugliano, MD, PhD

CONTACT

00390817462240; giuseppe.giugliano@unina.it

Giovanni Esposito, MD, PhD

CONTACT

00390817463075; espogiov@unina.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 14, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: July 1, 2020
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

IT (1)