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

Primary Purpose

Peripheral Artery Disease

Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Short DAPT
Long DAPT
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Artery Disease focused on measuring dual antiplatelet therapy, peripheral transluminal angioplasty

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Short DAPT

Long DAPT

Arm Description

Patients who will be treated after PTA with acetylsalicylic acid 100 mg/day life-long + clopidogrel 75 mg/day for 3 months

Patients who will be treated after PTA with acetylsalicylic acid 100 mg/day life-long + clopidogrel 75 mg/day for 12 months

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
June 9, 2016
Last Updated
February 13, 2019
Sponsor
Federico II University
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1. Study Identification

Unique Protocol Identification Number
NCT02798913
Brief Title
Effects of Prolonged DAPT After Lower Extremity Percutaneous Transluminal Angioplasty (PTA) in Patients With LE-PAD
Acronym
LONGDAPTPAD
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease
Keywords
dual antiplatelet therapy, peripheral transluminal angioplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Short DAPT
Arm Type
Experimental
Arm Description
Patients who will be treated after PTA with acetylsalicylic acid 100 mg/day life-long + clopidogrel 75 mg/day for 3 months
Arm Title
Long DAPT
Arm Type
Experimental
Arm Description
Patients who will be treated after PTA with acetylsalicylic acid 100 mg/day life-long + clopidogrel 75 mg/day for 12 months
Intervention Type
Drug
Intervention Name(s)
Short DAPT
Other Intervention Name(s)
3 months ASA + Clopidogrel
Intervention Description
acetylsalicylic acid 100 mg/day life-long + clopidogrel 75 mg/day for 3 months
Intervention Type
Drug
Intervention Name(s)
Long DAPT
Other Intervention Name(s)
12 months ASA + Clopidogrel
Intervention Description
acetylsalicylic acid 100 mg/day life-long + clopidogrel 75 mg/day for 12 months
Primary Outcome Measure Information:
Title
Incidence of Major Adverse Cardiovascular Events + incidence of Major Adverse Limb Events
Description
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
Secondary Outcome Measure Information:
Title
Incidence of minor and major bleedings according to the GUSTO classification
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giuseppe Giugliano, MD, PhD
Phone
00390817462240
Email
giuseppe.giugliano@unina.it
First Name & Middle Initial & Last Name or Official Title & Degree
Giovanni Esposito, MD, PhD
Phone
00390817463075
Email
espogiov@unina.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Trimarco
Organizational Affiliation
Federico II University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Giovanni Esposito, MD, PhD
Organizational Affiliation
Federico II University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Advanced Biomedical Sciences, University of Naples "Federico II"
City
Naples
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Giugliano, MD, PhD
Phone
00390817462240
Email
giuseppe.giugliano@unina.it

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Effects of Prolonged DAPT After Lower Extremity Percutaneous Transluminal Angioplasty (PTA) in Patients With LE-PAD

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