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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02798913

Acronym

LONGDAPTPAD

Enrollment

300

Registered

2016-06-14

Start date

2016-01-31

Completion date

2020-07-31

Last updated

2019-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Artery Disease

Keywords

dual antiplatelet therapy, peripheral transluminal angioplasty

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).

Interventions

DRUGShort DAPT

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

DRUGLong DAPT

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Italy

Contacts

Primary ContactGiuseppe Giugliano, MD, PhD

giuseppe.giugliano@unina.it00390817462240

Backup ContactGiovanni Esposito, MD, PhD

espogiov@unina.it00390817463075

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026