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Trial record 96 of 459 for:    ASPIRIN AND clopidogrel AND ischemic

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

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ClinicalTrials.gov Identifier: NCT02798913
Recruitment Status : Recruiting
First Posted : June 14, 2016
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Giuseppe Giugliano, Federico II University

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).

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Drug: Short DAPT Drug: Long DAPT Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Short DAPT
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
acetylsalicylic acid 100 mg/day life-long + clopidogrel 75 mg/day for 3 months
Other Name: 3 months ASA + Clopidogrel

Experimental: Long DAPT
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
acetylsalicylic acid 100 mg/day life-long + clopidogrel 75 mg/day for 12 months
Other Name: 12 months ASA + Clopidogrel




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Incidence of minor and major bleedings according to the GUSTO classification [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02798913


Contacts
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Contact: Giuseppe Giugliano, MD, PhD 00390817462240 giuseppe.giugliano@unina.it
Contact: Giovanni Esposito, MD, PhD 00390817463075 espogiov@unina.it

Locations
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Italy
Department of Advanced Biomedical Sciences, University of Naples "Federico II" Recruiting
Naples, Italy, 80131
Contact: Giuseppe Giugliano, MD, PhD    00390817462240    giuseppe.giugliano@unina.it   
Sponsors and Collaborators
Federico II University
Investigators
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Study Director: Bruno Trimarco Federico II University
Principal Investigator: Giovanni Esposito, MD, PhD Federico II University

Publications:

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Responsible Party: Giuseppe Giugliano, MD, PhD, Federico II University
ClinicalTrials.gov Identifier: NCT02798913     History of Changes
Other Study ID Numbers: 103/13
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Giuseppe Giugliano, Federico II University:
dual antiplatelet therapy
peripheral transluminal angioplasty

Additional relevant MeSH terms:
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Clopidogrel
Aspirin
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics