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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

Tracking Information
First Submitted Date  ICMJE June 9, 2016
First Posted Date  ICMJE June 14, 2016
Last Update Posted Date February 15, 2019
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2016)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02798913 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2016)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Prolonged DAPT After Lower Extremity Percutaneous Transluminal Angioplasty (PTA) in Patients With LE-PAD
Official Title  ICMJE Effects of Prolonged Dual Antiplatelet Therapy With Clopidogrel Plus Acetylsalicylic Acid (ASA) After Percutaneous Lower Extremity Revascularization in Patients With Peripheral Arterial Disease
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Artery Disease
Intervention  ICMJE
  • Drug: Short DAPT
    acetylsalicylic acid 100 mg/day life-long + clopidogrel 75 mg/day for 3 months
    Other Name: 3 months ASA + Clopidogrel
  • Drug: Long DAPT
    acetylsalicylic acid 100 mg/day life-long + clopidogrel 75 mg/day for 12 months
    Other Name: 12 months ASA + Clopidogrel
Study Arms  ICMJE
  • 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
    Intervention: Drug: Short DAPT
  • 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
    Intervention: Drug: Long DAPT
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 9, 2016)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Giuseppe Giugliano, MD, PhD 00390817462240 giuseppe.giugliano@unina.it
Contact: Giovanni Esposito, MD, PhD 00390817463075 espogiov@unina.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02798913
Other Study ID Numbers  ICMJE 103/13
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Giuseppe Giugliano, Federico II University
Study Sponsor  ICMJE Federico II University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bruno Trimarco Federico II University
Principal Investigator: Giovanni Esposito, MD, PhD Federico II University
PRS Account Federico II University
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP