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| Name | Class |
|---|---|
| Medical Research Agency, Poland | OTHER_GOV |
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SAFE-LAAC CKD 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 in patients with the end-stage renal disease treated with chronic haemodialysis or peritoneal dialysis
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 and may significantly contribute to long-term safety and efficacy. Nowadays LAAC is mainly performed in patients with contraindications for oral anticoagulation due to high bleeding risk. Dialyzed patients with end-stage renal disease and atrial fibrillation have simultaneously high thromboembolic and bleeding risk. Such patients were excluded from randomized trials and data on the LAAC efficacy in this population is limited thus prospective studies are warranted.
Objective:
SAFE-LAAC CKD Trial has been designed as a comparative health effectiveness study with the following aims:
Patient population:
Patients (n=80) with the end-stage renal disease treated with chronic haemodialysis or peritoneal dialysis, 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, 2. data on the safety and efficacy of LAAC in dialyzed patients, and 3. data to support power calculations for designing future randomized trials.
Methodology:
SAFE LAAC CKD 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| short postimplantation dual antiplatelet therapy | Drug | continuing dual antiplatelet therapy up until 6 months after left atrial appendage occlusion with Amplatzer Amulet |
|
| 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) | Event rates reported per 100 patient-years (calculated as 100*Number of Participants with events/Total patient-years); | 17 months |
| Safety (moderate and/or severe bleeding (BARC type 2, 3, and 5) | Event rates reported per 100 patient-years (calculated as 100*Number of Participants with events/Total patient-years); | 17 months |
| Measure | Description | Time Frame |
|---|---|---|
| Ischemic stroke | Event rate reported per 100 patient-years (calculated as 100*Number of Participants with events/Total patient-years); | 17 months |
| Transient ischaemic attack | Event rate reported per 100 patient-years (calculated as 100*Number of Participants with events/Total patient-years); |
| Measure | Description | Time Frame |
|---|---|---|
| Number of new ischemic brain lesions on magnetic resonance imaging | 17 months | |
| Volume of new ischemic brain lesions on magnetic resonance imaging | 17 months | |
| The change from baseline in the cumulative dose of heparin anticoagulation used during haemodialysis |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Radoslaw Pracon, MD PhD | Contact | 22 343 43 42 | +48 | rpracon@ikard.pl |
| Marcin Demkow, MD PhD | Contact | 22 343 43 42 | +48 | mdemkow@ikard.pl |
| Name | Affiliation | Role |
|---|---|---|
| Radoslaw Pracon, MD PhD | Coronary and Structural Heart Diseases Department, National Institute of Cardiology, Warsaw, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Cardiology | Recruiting | Warsaw | Masovian Voivodeship | 04-628 | Poland |
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| extended postimplantation dual antiplatelet therapy | Drug | stopping dual antiplatelet therapy after 30 days after left atrial appendage occlusion with Amplatzer Amulet and continuing single antiplatelet agent up until 6 months |
|
| long-term treatment with a single antiplatelet agent | Drug | continuing long-term treatment with single antiplatelet agent |
|
| 6 months treatment with a single antiplatelet agent | Drug | continuing single antiplatelet agent up until 6 months |
|
| 17 months |
| Peripheral embolism | Event rate reported per 100 patient-years (calculated as 100*Number of Participants with events/Total patient-years); | 17 months |
| Nonfatal myocardial infarction | Event rate reported per 100 patient-years (calculated as 100*Number of Participants with events/Total patient-years); | 17 months |
| Cardiovascular mortality | Event rate reported per 100 patient-years (calculated as 100*Number of Participants with events/Total patient-years); | 17 months |
| All-cause mortality | Event rate reported per 100 patient-years (calculated as 100*Number of Participants with events/Total patient-years); | 17 months |
| Moderate and/or severe bleeding (BARC type 2,3, and 5) | Event rate reported per 100 patient-years (calculated as 100*Number of Participants with events/Total patient-years); | 17 months |
| Left atrial appendage thrombus | Event rate reported per 100 patient-years (calculated as 100*Number of Participants with events/Total patient-years); | 17 months |
| Any bleeding | Event rate reported per 100 patient-years (calculated as 100*Number of Participants with events/Total patient-years); | 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*Number of Participants with events/Total patient-years); | 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. | 17 months |
| Dialysis access thrombosis | Event rate reported per 100 patient-years (calculated as 100*Number of Participants with events/Total patient-years); | 17 months |
| Safety and efficacy of the procedure in the periprocedural period and 1-month follow-up based on registry data | 1-month event rate of: cardiac arrest, device embolism, tamponade, pericardial effusion, stroke/TIA/myocardial infarction/peripheral embolus, access site bleeding/vascular complications, bleeding complications unrelated to access site (Number of Participants with event/Total patient number) | 1-month |
| 17 months |
| The change from baseline in the dose of erythropoietin used | 17 months |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D008134 | Long-Term Care |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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