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

July 10, 2023 updated by: National Institute of Cardiology, Warsaw, Poland

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  1. compare the safety and efficacy of 30 days vs. 6 months of dual antiplatelet therapy following LAAC with Amplatzer or WATCHMAN device (randomized comparison)
  2. 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Radoslaw Pracon, MD PhD
  • Phone Number: +48 22 343 43 42
  • Email: rpracon@ikard.pl

Study Contact Backup

  • Name: Marcin Demkow, MD PhD
  • Phone Number: +48 22 343 43 42
  • Email: mdemkow@ikard.pl

Study Locations

  • Poland
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 04-628
        • Recruiting
        • National Institute of Cardiology
        • Contact:
          • Radoslaw Pracon, MD PhD
          • Phone Number: +48 22 343 43 42
          • Email: rpracon@ikard.pl
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 30 days DAPT and long-term treatment with a single antiplatelet agent
short postimplantation dual antiplatelet therapy and long-term treatment with a single antiplatelet agent
Drug: short postimplantation dual antiplatelet therapy
continuing dual antiplatelet therapy up until 6 months after left atrial appendage occlusion with Amplatzer or WATCHMAN device
Drug: long-term treatment with a single antiplatelet agent
continuing long-term treatment with single antiplatelet agent
Other: 6 months DAPT and long-term treatment with a single antiplatelet agent
extended postimplantation dual antiplatelet therapy and long-term treatment with a single antiplatelet agent
Drug: long-term treatment with a single antiplatelet agent
continuing long-term treatment with single antiplatelet agent
Drug: extended postimplantation dual antiplatelet therapy
stopping dual antiplatelet therapy after 30 days after left atrial appendage occlusion with Amplatzer or WATCHMAN device
Other: 30 days DAPT and 6 months treatment with a single antiplatelet agent
short postimplantation dual antiplatelet therapy and 6 months treatment with a single antiplatelet agent
Drug: short postimplantation dual antiplatelet therapy
continuing dual antiplatelet therapy up until 6 months after left atrial appendage occlusion with Amplatzer or WATCHMAN device
Drug: 6 months treatment with a single antiplatelet agent
continuing single antiplatelet agent up until 6 months
Other: 6 months DAPT and 6 months treatment with a single antiplatelet agent
extended postimplantation dual antiplatelet therapy and 6 months treatment with a single antiplatelet agent
Drug: extended postimplantation dual antiplatelet therapy
stopping dual antiplatelet therapy after 30 days after left atrial appendage occlusion with Amplatzer or WATCHMAN device
Drug: 6 months treatment with a single antiplatelet agent
continuing single antiplatelet agent up until 6 months

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy (a composite of ischemic stroke, transient ischaemic attack, peripheral embolism, nonfatal myocardial infarction, cardiovascular mortality, all-cause mortality, left atrial appendage thrombus)
Time Frame: 17 months
Event rates reported per 100 patient-years (calculated as 100*N events/Total patient-years);
17 months
Safety (moderate and/or severe bleeding (BARC type 2, 3, and 5)
Time Frame: 17 months
Event rates reported per 100 patient-years (calculated as 100*N events/Total patient-years);
17 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ischemic stroke
Time Frame: 17 months
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
17 months
Transient ischaemic attack
Time Frame: 17 months
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
17 months
Peripheral embolism
Time Frame: 17 months
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
17 months
Nonfatal myocardial infarction
Time Frame: 17 months
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
17 months
Cardiovascular mortality
Time Frame: 17 months
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
17 months
All-cause mortality
Time Frame: 17 months
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
17 months
Moderate and/or 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);
17 months
Left atrial appendage thrombus
Time Frame: 17 months
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
17 months
Any bleeding
Time Frame: 17 months
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
17 months
New moderate or major (≥4 mm) ischemic brain lesions on magnetic resonance imaging
Time Frame: 17 months
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years)
17 months
Change in cognition score as detected by the Addenbrooke's cognitive examination (ACE-III)
Time Frame: 17 months
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
17 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Number of new ischemic brain lesions on magnetic resonance imaging
Time Frame: 17 months
17 months
Volume of new ischemic brain lesions on magnetic resonance imaging
Time Frame: 17 months
17 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute of Cardiology, Warsaw, Poland

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medical Research Agency, Poland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Radoslaw Pracon, MD PhD, Coronary and Structural Heart Diseases Department, National Institute of Cardiology, Warsaw, Poland
  • Principal Investigator: Marcin Demkow, MD PhD, Coronary and Structural Heart Diseases Department, National Institute of Cardiology, Warsaw, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 23, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 23, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 23, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2.52/IV/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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