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

Primary Purpose

Atrial Fibrillation

Status
Recruiting
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
short postimplantation dual antiplatelet therapy
extended postimplantation dual antiplatelet therapy
long-term treatment with a single antiplatelet agent
6 months treatment with a single antiplatelet agent
Sponsored by
National Institute of Cardiology, Warsaw, Poland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, stroke, bleeding, left atrial appendage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Successful left atrial appendage occlusion with Amplatzer or WATCHMAN device within 37 days before 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 the randomized antiplatelet treatment regimen
  • Participant is willing to sign the study informed consent form

Exclusion Criteria:

  • Indications to dual antiplatelet therapy other than atrial fibrillation and/or left atrial appendage occlusion at the time of enrollment or predicted appearance of such indications within the duration of the trial (e.g. planned coronary revascularization)
  • Indications to anticoagulation at the time of enrollment and/or predicted appearance of such indications within the duration of the trial (e.g. pulmonary embolism)
  • Known allergy to clopidogrel and/or acetylsalicylic acid precluding its administration as specified by the protocol
  • Any known inborn or acquired coagulation disorders
  • Peridevice leak >5mm on imaging study preceding enrollment
  • Left atrial thrombus on an imaging study performed after successful left atrial appendage closure but before enrollment
  • Life expectancy of fewer than 18 months
  • 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 breastfeeding; women of childbearing potential who do not consent to apply at least two methods of contraception. This criterion does not apply to women 2 years post menopause (with negative pregnancy test 24 hours prior to randomization if <55 years old) or after surgical sterilization

Sites / Locations

  • National Institute of CardiologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

30 days DAPT and long-term treatment with a single antiplatelet agent

6 months DAPT and long-term treatment with a single antiplatelet agent

30 days DAPT and 6 months treatment with a single antiplatelet agent

6 months DAPT and 6 months treatment with a single antiplatelet agent

Arm Description

short postimplantation dual antiplatelet therapy and long-term treatment with a single antiplatelet agent

extended postimplantation dual antiplatelet therapy and long-term treatment with a single antiplatelet agent

short postimplantation dual antiplatelet therapy and 6 months treatment with a single antiplatelet agent

extended postimplantation dual antiplatelet therapy and 6 months treatment with a single antiplatelet agent

Outcomes

Primary Outcome Measures

Efficacy (a composite of ischemic stroke, transient ischaemic attack, peripheral embolism, nonfatal myocardial infarction, cardiovascular mortality, all-cause mortality, left atrial appendage thrombus)
Event rates reported per 100 patient-years (calculated as 100*N events/Total patient-years);
Safety (moderate and/or severe bleeding (BARC type 2, 3, and 5)
Event rates reported per 100 patient-years (calculated as 100*N events/Total patient-years);

Secondary Outcome Measures

Ischemic stroke
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
Transient ischaemic attack
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
Peripheral embolism
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
Nonfatal myocardial infarction
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
Cardiovascular mortality
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
All-cause mortality
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
Moderate and/or severe bleeding (BARC type 2,3, and 5)
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
Left atrial appendage thrombus
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
Any bleeding
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
New moderate or major (≥4 mm) ischemic brain lesions on magnetic resonance imaging
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years)
Change in cognition score as detected by the Addenbrooke's cognitive examination (ACE-III)
ACE-III is a screening test that is composed of tests of attention, orientation, memory, language, visual perceptual, and visuospatial skills. The total range of raw score is 0-100. A higher score indicates more intact cognitive functioning

Full Information

First Posted
February 1, 2018
Last Updated
July 10, 2023
Sponsor
National Institute of Cardiology, Warsaw, Poland
Collaborators
Medical Research Agency, Poland
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1. Study Identification

Unique Protocol Identification Number
NCT03445949
Brief Title
Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure
Acronym
SAFE-LAAC
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 23, 2018 (Actual)
Primary Completion Date
June 23, 2025 (Anticipated)
Study Completion Date
June 23, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Cardiology, Warsaw, Poland
Collaborators
Medical Research Agency, Poland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 or WATCHMAN device
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, an optimal antithrombotic treatment regimen following successful LAAC remains an unresolved issue. The scope and duration of antiplatelet treatment following LAAC are of paramount importance as they 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 health effectiveness study with the following aims: compare the safety and efficacy of 30 days vs. 6 months of dual antiplatelet therapy following LAAC with Amplatzer or WATCHMAN device (randomized comparison) compare safety and efficacy of stopping all antithrombotic and antiplatelet agents 6 months after LAAC vs. long-term treatment with a single antiplatelet agent (nonrandomized comparison) Patient population: Patients (n=200) after successful LAAC with Amplatzer or WATCHMAN device. Perspective: Results of this pilot trial will provide: 1. data to aid practitioners and guideline writers recommend the 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 (planned contribution of 7 centers in Poland), open-label, comparative health effectiveness trial with central, independent adjudication of events comprising the 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 5 years. The enrollment phase has been planned for 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, stroke, bleeding, left atrial appendage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
30 days DAPT and long-term treatment with a single antiplatelet agent
Arm Type
Other
Arm Description
short postimplantation dual antiplatelet therapy and long-term treatment with a single antiplatelet agent
Arm Title
6 months DAPT and long-term treatment with a single antiplatelet agent
Arm Type
Other
Arm Description
extended postimplantation dual antiplatelet therapy and long-term treatment with a single antiplatelet agent
Arm Title
30 days DAPT and 6 months treatment with a single antiplatelet agent
Arm Type
Other
Arm Description
short postimplantation dual antiplatelet therapy and 6 months treatment with a single antiplatelet agent
Arm Title
6 months DAPT and 6 months treatment with a single antiplatelet agent
Arm Type
Other
Arm Description
extended postimplantation dual antiplatelet therapy and 6 months treatment with a single antiplatelet agent
Intervention Type
Drug
Intervention Name(s)
short postimplantation dual antiplatelet therapy
Intervention Description
continuing dual antiplatelet therapy up until 6 months after left atrial appendage occlusion with Amplatzer or WATCHMAN device
Intervention Type
Drug
Intervention Name(s)
extended postimplantation dual antiplatelet therapy
Intervention Description
stopping dual antiplatelet therapy after 30 days after left atrial appendage occlusion with Amplatzer or WATCHMAN device
Intervention Type
Drug
Intervention Name(s)
long-term treatment with a single antiplatelet agent
Intervention Description
continuing long-term treatment with single antiplatelet agent
Intervention Type
Drug
Intervention Name(s)
6 months treatment with a single antiplatelet agent
Intervention Description
continuing single antiplatelet agent up until 6 months
Primary Outcome Measure Information:
Title
Efficacy (a composite of ischemic stroke, transient ischaemic attack, peripheral embolism, nonfatal myocardial infarction, cardiovascular mortality, all-cause mortality, left atrial appendage thrombus)
Description
Event rates reported per 100 patient-years (calculated as 100*N events/Total patient-years);
Time Frame
17 months
Title
Safety (moderate and/or severe bleeding (BARC type 2, 3, and 5)
Description
Event rates reported per 100 patient-years (calculated as 100*N events/Total patient-years);
Time Frame
17 months
Secondary Outcome Measure Information:
Title
Ischemic stroke
Description
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
Time Frame
17 months
Title
Transient ischaemic attack
Description
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
Time Frame
17 months
Title
Peripheral embolism
Description
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
Time Frame
17 months
Title
Nonfatal myocardial infarction
Description
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
Time Frame
17 months
Title
Cardiovascular mortality
Description
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
Time Frame
17 months
Title
All-cause mortality
Description
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
Time Frame
17 months
Title
Moderate and/or severe bleeding (BARC type 2,3, and 5)
Description
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
Time Frame
17 months
Title
Left atrial appendage thrombus
Description
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
Time Frame
17 months
Title
Any bleeding
Description
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
Time Frame
17 months
Title
New moderate or major (≥4 mm) ischemic brain lesions on magnetic resonance imaging
Description
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years)
Time Frame
17 months
Title
Change in cognition score as detected by the Addenbrooke's cognitive examination (ACE-III)
Description
ACE-III is a screening test that is composed of tests of attention, orientation, memory, language, visual perceptual, and visuospatial skills. The total range of raw score is 0-100. A higher score indicates more intact cognitive functioning
Time Frame
17 months
Other Pre-specified Outcome Measures:
Title
Number of new ischemic brain lesions on magnetic resonance imaging
Time Frame
17 months
Title
Volume of new ischemic brain lesions on magnetic resonance imaging
Time Frame
17 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Successful left atrial appendage occlusion with Amplatzer or WATCHMAN device within 37 days before 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 the randomized antiplatelet treatment regimen Participant is willing to sign the study informed consent form Exclusion Criteria: Indications to dual antiplatelet therapy other than atrial fibrillation and/or left atrial appendage occlusion at the time of enrollment or predicted appearance of such indications within the duration of the trial (e.g. planned coronary revascularization) Indications to anticoagulation at the time of enrollment and/or predicted appearance of such indications within the duration of the trial (e.g. pulmonary embolism) Known allergy to clopidogrel and/or acetylsalicylic acid precluding its administration as specified by the protocol Any known inborn or acquired coagulation disorders Peridevice leak >5mm on imaging study preceding enrollment Left atrial thrombus on an imaging study performed after successful left atrial appendage closure but before enrollment Life expectancy of fewer than 18 months 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 breastfeeding; women of childbearing potential who do not consent to apply at least two methods of contraception. This criterion does not apply to women 2 years post menopause (with negative pregnancy test 24 hours prior to randomization if <55 years old) or after surgical sterilization
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Radoslaw Pracon, MD PhD
Phone
22 343 43 42
Ext
+48
Email
rpracon@ikard.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Marcin Demkow, MD PhD
Phone
22 343 43 42
Ext
+48
Email
mdemkow@ikard.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Radoslaw Pracon, MD PhD
Organizational Affiliation
Coronary and Structural Heart Diseases Department, National Institute of Cardiology, Warsaw, Poland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marcin Demkow, MD PhD
Organizational Affiliation
Coronary and Structural Heart Diseases Department, National Institute of Cardiology, Warsaw, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Cardiology
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
04-628
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Radoslaw Pracon, MD PhD
Phone
22 343 43 42
Ext
+48
Email
rpracon@ikard.pl
First Name & Middle Initial & Last Name & Degree
Marcin Demkow, MD PhD
Phone
22 343 43 42
Ext
+48
Email
mdemkow@ikard.pl

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure

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