Atrial FibrillationPhase 4SAFE-LAACNCT03445949
Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure
A Phase 4 study testing short postimplantation dual antiplatelet therapy, extended postimplantation dual antiplatelet therapy and long-term treatment with a single antiplatelet agent in people with Atrial Fibrillation, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- short postimplantation dual antiplatelet therapy, extended postimplantation dual antiplatelet therapy and long-term treatment with a single antiplatelet agent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 23 Jan 2018to 23 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
National Institute of Cardiology
Warsaw, Masovian Voivodeship, 04-628
Radoslaw Pracon, MD PhD, 22 343 43 42 ext. +48, rpracon@ikard.pl
Marcin Demkow, MD PhD, 22 343 43 42 ext. +48, mdemkow@ikard.pl
About this study
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
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
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- 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
- Keywords
- atrial fibrillation, stroke, bleeding, left atrial appendage
- Medical subject headings
- Atrial Fibrillation, Stroke, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short postimplantation dual antiplatelet therapyDrug
continuing dual antiplatelet therapy up until 6 months after left atrial appendage occlusion with Amplatzer or WATCHMAN device
extended postimplantation dual antiplatelet therapyDrug
stopping dual antiplatelet therapy after 30 days after left atrial appendage occlusion with Amplatzer or WATCHMAN device
long-term treatment with a single antiplatelet agentDrug
continuing long-term treatment with single antiplatelet agent
6 months treatment with a single antiplatelet agentDrug
continuing single antiplatelet agent up until 6 months
| Study group | Role | What they receive |
|---|---|---|
| 30 days DAPT and long-term treatment with a single antiplatelet agent | Other | short postimplantation dual antiplatelet therapy and long-term treatment with a single antiplatelet agent Receives: Drug: short postimplantation dual antiplatelet therapy; Drug: long-term treatment with a single antiplatelet agent |
| 6 months DAPT and long-term treatment with a single antiplatelet agent | Other | extended postimplantation dual antiplatelet therapy and long-term treatment with a single antiplatelet agent Receives: Drug: extended postimplantation dual antiplatelet therapy; Drug: long-term treatment with a single antiplatelet agent |
| 30 days DAPT and 6 months treatment with a single antiplatelet agent | Other | short postimplantation dual antiplatelet therapy and 6 months treatment with a single antiplatelet agent Receives: Drug: short postimplantation dual antiplatelet therapy; Drug: 6 months treatment with a single antiplatelet agent |
| 6 months DAPT and 6 months treatment with a single antiplatelet agent | Other | extended postimplantation dual antiplatelet therapy and 6 months treatment with a single antiplatelet agent Receives: Drug: extended postimplantation dual antiplatelet therapy; Drug: 6 months treatment with a single antiplatelet agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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);
Measured: 17 months
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);
Measured: 17 months
Secondary outcomes (11)
Ischemic stroke
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
Measured: 17 months
Transient ischaemic attack
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
Measured: 17 months
Peripheral embolism
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
Measured: 17 months
Nonfatal myocardial infarction
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
Measured: 17 months
Cardiovascular mortality
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
Measured: 17 months
All-cause mortality
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
Measured: 17 months
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);
Measured: 17 months
Left atrial appendage thrombus
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
Measured: 17 months
Any bleeding
Event rate reported per 100 patient-years (calculated as 100*N events/Total patient-years);
Measured: 17 months
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)
Measured: 17 months
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
Measured: 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start23 Jan 2018
- Primary completion23 Jun 2025 (estimated)
- Study completion23 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Agency, Poland
- Responsible party
- Sponsor
- Investigators
- Radoslaw Pracon, MD PhD, Principal investigator, Coronary and Structural Heart Diseases Department, National Institute of Cardiology, Warsaw, PolandMarcin Demkow, MD PhD, Principal investigator, Coronary and Structural Heart Diseases Department, National Institute of Cardiology, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03445949
- Sponsor's protocol ID
- 2.52/IV/16
- Acronym
- SAFE-LAAC
- Status last verified
- Jul 2023
- First submitted
- 1 Feb 2018
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03445949
- Acronym / sponsor ID
- SAFE-LAAC / 2.52/IV/16
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, stroke, bleeding, left atrial appendage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Collaborators
- Medical Research Agency, Poland
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 23 Jun 2025 (estimated)
- Study completion
- 23 Jun 2027 (estimated)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 30 days DAPT and long-term treatment with a single antiplatelet agent | Other | Drug: short postimplantation dual antiplatelet therapy, Drug: long-term treatment with a single antiplatelet agentshort postimplantation dual antiplatelet therapy and long-term treatment with a single antiplatelet agent |
| 6 months DAPT and long-term treatment with a single antiplatelet agent | Other | Drug: extended postimplantation dual antiplatelet therapy, Drug: long-term treatment with a single antiplatelet agentextended postimplantation dual antiplatelet therapy and long-term treatment with a single antiplatelet agent |
| 30 days DAPT and 6 months treatment with a single antiplatelet agent | Other | Drug: short postimplantation dual antiplatelet therapy, Drug: 6 months treatment with a single antiplatelet agentshort postimplantation dual antiplatelet therapy and 6 months treatment with a single antiplatelet agent |
| 6 months DAPT and 6 months treatment with a single antiplatelet agent | Other | Drug: extended postimplantation dual antiplatelet therapy, Drug: 6 months treatment with a single antiplatelet agentextended postimplantation dual antiplatelet therapy and 6 months treatment with a single antiplatelet agent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| short postimplantation dual antiplatelet therapycontinuing dual antiplatelet therapy up until 6 months after left atrial appendage occlusion with Amplatzer or WATCHMAN device | Drug | 30 days DAPT and 6 months treatment with a single antiplatelet agent, 30 days DAPT and long-term treatment with a single antiplatelet agent |
| extended postimplantation dual antiplatelet therapystopping dual antiplatelet therapy after 30 days after left atrial appendage occlusion with Amplatzer or WATCHMAN device | Drug | 6 months DAPT and 6 months treatment with a single antiplatelet agent, 6 months DAPT and long-term treatment with a single antiplatelet agent |
| long-term treatment with a single antiplatelet agentcontinuing long-term treatment with single antiplatelet agent | Drug | 30 days DAPT and long-term treatment with a single antiplatelet agent, 6 months DAPT and long-term treatment with a single antiplatelet agent |
| 6 months treatment with a single antiplatelet agentcontinuing single antiplatelet agent up until 6 months | Drug | 30 days DAPT and 6 months treatment with a single antiplatelet agent, 6 months DAPT and 6 months treatment with a single antiplatelet agent |
Primary outcome
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);
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);
11 secondary outcomes
Ischemic stroke
Time frame: 17 months
Transient ischaemic attack
Time frame: 17 months
Peripheral embolism
Time frame: 17 months
Nonfatal myocardial infarction
Time frame: 17 months
Cardiovascular mortality
Time frame: 17 months
All-cause mortality
Time frame: 17 months
Moderate and/or severe bleeding (BARC type 2,3, and 5)
Time frame: 17 months
Left atrial appendage thrombus
Time frame: 17 months
Any bleeding
Time frame: 17 months
New moderate or major (≥4 mm) ischemic brain lesions on magnetic resonance imaging
Time frame: 17 months
Change in cognition score as detected by the Addenbrooke's cognitive examination (ACE-III)
Time frame: 17 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Radoslaw Pracon, MD PhD principal investigator
Coronary and Structural Heart Diseases Department, National Institute of Cardiology, Warsaw, Poland
Marcin Demkow, MD PhD principal investigator
Coronary and Structural Heart Diseases Department, National Institute of Cardiology, Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing short postimplantation dual antiplatelet therapy, extended postimplantation dual antiplatelet therapy and long-term treatment with a single antiplatelet agent in people with Atrial Fibrillation, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Radoslaw Pracon, MD PhD (22 343 43 42 ext. +48, rpracon@ikard.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.