Effects of Prolonged Dual Antiplatelet Therapy With Clopidogrel Plus Acetylsalicylic Acid (ASA) After Percutaneous Lower Extremity Revascularization in Patients With Peripheral Arterial Disease
Overview
- Phase
- Phase 3
- Intervention
- Short DAPT
- Conditions
- Peripheral Artery Disease
- Sponsor
- Federico II University
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Incidence of Major Adverse Cardiovascular Events + incidence of Major Adverse Limb Events
- Last Updated
- 7 years ago
Overview
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).
Investigators
Giuseppe Giugliano
MD, PhD
Federico II University
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
Arms & Interventions
Short DAPT
Patients who will be treated after PTA with acetylsalicylic acid 100 mg/day life-long + clopidogrel 75 mg/day for 3 months
Intervention: Short 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
Intervention: Long DAPT
Outcomes
Primary Outcomes
Incidence of Major Adverse Cardiovascular Events + incidence of Major Adverse Limb Events
Time Frame: 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 Outcomes
- Incidence of minor and major bleedings according to the GUSTO classification(24 months post-PTA)