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

Federico II University

Status and phase: Unknown; Phase 3

Conditions: Peripheral Artery Disease

Treatments: Drug: Short DAPT; Drug: Long DAPT

Study type: Interventional

Funder types: Other

Identifiers

NCT02798913

103/13

Details and patient eligibility

About

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).

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Short DAPT

Experimental group

Description:

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

Treatment:

Drug: Short DAPT

Long DAPT

Experimental group

Description:

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

Treatment:

Drug: Long DAPT