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Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure (SAFE-LAAC)

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ClinicalTrials.gov Identifier: NCT03445949
Recruitment Status : Recruiting
First Posted : February 26, 2018
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Institute of Cardiology, Warsaw, Poland

Brief Summary:
SAFE-LAAC Trial has been designed to gather data on the most optimal strategy of antiplatelet therapy after transcatheter left atrial appendage occlusion with Amplatzer Amulet device

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: short postimplantation dual antiplatelet therapy Drug: extended postimplantation dual antiplatelet therapy Phase 4

Detailed Description:

Background:

Transcatheter left atrial appendage closure (LAAC) has been shown to be non-inferior to oral anticoagulation in preventing cardioembolic strokes associated with atrial fibrillation. However, optimal antithrombotic treatment regimen following successful LAAC remains an unresolved issue. The scope and duration of antiplatelet treatment following LAAC is of paramount importance as it may significantly contribute to post-procedural as well as long-term procedural safety and efficacy.

Objective:

SAFE-LAAC Trial has been designed as a comparative heath effectiveness study with the following aims:

  1. compare safety and efficacy of 30 days vs. 6 months of dual antiplatelet therapy following LAAC with Amplatzer Amulet device (randomized comparison)
  2. compare safety and efficacy of stopping all antithrombotic and antiplatelet agents 6 months after LAAC vs. long-term treatment with single antiplatelet agent (nonrandomized comparison)

Patient population:

Patients (n=160) with contraindications to oral anticoagulation, after successful LAAC with Amplatzer Amulet device.

Perspective:

Results of this pilot trial will provide: 1. data to aid practitioners and guideline writers recommend most optimal antithrombotic treatment after LAAC, and 2. data to support power calculations for designing future randomized trials.

Methodology:

SAFE LAAC has been designed as a multicenter (4-5 centers in Poland), open-label, comparative heath effectiveness trial with central, independent adjudication of events comprising primary end-point. The first part of the trial is randomized and after 6 months of follow-up continues for another 12 months as a non-randomized study.

Timeline:

The duration of the trial has been planned for 3 years. The enrollment phase will continue over 1.5 years and follow up will extend to 3 years.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimal Antiplatelet Treatment to Achieve Stroke Avoidance and Fall in Bleeding Events Following Left Atrial Appendage Closure (SAFE-LAAC). Comparative Health Effectiveness Randomized Trial - PILOT Study
Actual Study Start Date : January 23, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
30 days DAPT
short postimplantation dual antiplatelet therapy
Drug: short postimplantation dual antiplatelet therapy
continuing dual antiplatelet therapy up until 6 months after left atrial appendage occlusion with Amplatzer Amulet

6 months DAPT
extended postimplantation dual antiplatelet therapy
Drug: extended postimplantation dual antiplatelet therapy
stopping dual antiplatelet therapy after 30 days after left atrial appendage occlusion with Amplatzer Amulet and continuing single antiplatelet agent up until 6 months




Primary Outcome Measures :
  1. Composite of stroke, transient ischaemic attack, peripheral embolism, nonfatal myocardial infarction, cardiovascular mortality, all cause mortality, moderate and severe bleeding (BARC type 2,3, and 5), left atrial appendage thrombus [ Time Frame: 17 months ]
    Event rates reported per 100 patient-years (calculated as 100*N events/Total patient-years);


Secondary Outcome Measures :
  1. stroke [ Time Frame: 17 months ]
    Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);

  2. transient ischaemic attack [ Time Frame: 17 months ]
    Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);

  3. peripheral embolism [ Time Frame: 17 months ]
    Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);

  4. nonfatal myocardial infarction [ Time Frame: 17 months ]
    Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);

  5. cardiovascular mortality [ Time Frame: 17 months ]
    Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);

  6. all cause mortality [ Time Frame: 17 months ]
    Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);

  7. moderate and severe bleeding (BARC type 2,3, and 5) [ Time Frame: 17 months ]
    Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);

  8. left atrial appendage thrombus [ Time Frame: 17 months ]
    Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • successful left atrial appendage occlusion with Amulet device within 37 days prior to randomization.
  • treatment with dual antiplatelet therapy (clopidogrel and acetylsalicylic acid) between left atrial appendage closure and randomization
  • participant's age 18 years or older at the time of signing the informed consent form
  • participant is willing to follow all study procedures; especially randomized antiplatelet treatment regimen and follow-up visits with transesophageal echocardiography when applicable
  • participant is willing to sign the study informed consent form

Exclusion Criteria:

  • indications to dual antiplatelet therapy other than atrial fibrillation or left atrial appendage occlusion at the time of enrollment or predicted appearance of such indications within the duration of the trial (eg. coronary artery disease)
  • indications to anticoagulation at the time of enrollment or predicted appearance of such indications within the duration of the trial (eg. pulmonary embolism)
  • known allergy to clopidogrel or acetylsalicylic acid precluding its administration as specified by the protocol
  • any known inborn or acquired coagulation disorders
  • poor tolerance of or technical difficulties with performing transesophageal echocardiography
  • peridevice leak >5mm on transesophageal echocardiography study preceding enrollment
  • left atrial thrombus on transesophageal echocardiography study performed after successful left atrial appendage closure but before enrollment
  • life expectancy of less than 18months
  • participation in other clinical studies with experimental therapies at the time of enrollment and preceding 3 months
  • chronic kidney disease stage IV and V
  • women who are pregnant or breast feeding; women of childbearing potential who do not consent to apply at least to methods of contraception. This criterion does not apply to postmenopausal women

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): NCT03445949


Contacts
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Contact: Radoslaw Pracon, MD PhD 22 343 43 42 ext +48 rpracon@ikard.pl
Contact: Marcin Demkow, MD PhD 22 343 43 42 ext +48 mdemkow@ikard.pl

Locations
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Poland
Institute of Cardiology Recruiting
Warsaw, Mazowieckie, Poland, 04-628
Contact: Radoslaw Pracon, MD PhD    22 343 43 42 ext +48    rpracon@ikard.pl   
Contact: Marcin Demkow, MD PhD    22 343 43 42 ext +48    mdemkow@ikard.pl   
Sponsors and Collaborators
Institute of Cardiology, Warsaw, Poland
Investigators
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Principal Investigator: Radoslaw Pracon, MD PhD Coronary and Structural Heart Diseases Department, Institute of Cardiology, Warsaw, Poland
Principal Investigator: Marcin Demkow, MD PhD Coronary and Structural Heart Diseases Department, Institute of Cardiology, Warsaw, Poland

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Responsible Party: Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT03445949     History of Changes
Other Study ID Numbers: 2.52/IV/16
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institute of Cardiology, Warsaw, Poland:
atrial fibrillation, stroke, bleeding, left atrial appendage

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes