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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-502986-92-00 | Other Identifier | EU-CT |
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| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
| Gødstrup Hospital | OTHER |
| Aarhus University Hospital | OTHER |
| Aalborg University Hospital |
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Left atrial appendage (LAA) closure has become a frequent addition to oral anticoagulation in patients with atrial fibrillation who undergo cardiac surgery. The procedure significantly reduces the risk of stroke and systemic embolism, which may render anticoagulation unnecessary or even harmful when considering the associated increased risk of bleeding. A clinical trial to address the need for anticoagulation after LAA closure is needed.
The ATLAAC trial will enroll 1220 patients with atrial fibrillation who have previously undergone surgical LAA closure. Patients will undergo a cardiac CT-scan to determine if LAA closure was successful and patients with successful closure will be randomized to continue or discontinue anticoagulation. The trial will assess the risk of ischemic stroke, peripheral arterial embolism, and major bleeding during the randomized intervention
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Discontinue OAC | Experimental | OAC stopped for the duration of the trial |
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| Continue OAC | No Intervention | OAC continued for the duration of the trial |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OAC will be discontinued for the duration of the trial | Drug | Discontinuation of warfarin, dabigatran, rivaroxaban, apixaban or edoxaban |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with ischemic strokes, peripheral arterial embolisms and major bleedings | Composite endpoint including the occurrence of ischemic stroke, peripheral arterial embolism, and major bleeding (ISTH definition) | After 128 primary outcome events (approx 4 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of stroke | According to Scandinavian Stroke Scale (0-58), lower scores mean worse outcomes | After 128 primary outcome events (approx 4 years) |
| Occurence of transient ischemic attacks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristina Gosvig, M.D. | Contact | +4551520696 | kristina.gosvig@rsyd.dk | |
| Julie Goller, M.D. | Contact | 22951855 | julie.goller@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Lars Peter Riber, DMSc | Odense University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Not yet recruiting | Copenhagen | Capital Region | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40246048 | Derived | Gosvig K, Goller J, Hansson NH, Brandes A, Modrau I, Rasmussen LF, Eskesen K, Jensen AKG, Belley-Cote E, Whitlock R, Riber LPS. Rationale and design of the anticoagulant therapy after left atrial appendage closure (ATLAAC) trial. Am Heart J. 2025 Sep;287:86-93. doi: 10.1016/j.ahj.2025.04.015. Epub 2025 Apr 15. |
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| OTHER |
| Population Health Research Institute | OTHER |
| Region of Southern Denmark | OTHER |
Patients will be randomized to either continue or discontinue oral anticoagulant therapy
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Blinding of patients and physicians is not possible due to different types of oral anticoagulant therapy within the same interventional arm and the need for continuous monitoring of treatment with warfarin.However, since the primary outcome is not a subjectively reported outcome, lack of blinding presents less risk of bias.
The investigators responsible for data collection and the Endpoint Adjudication Committee will be blinded to the randomization.
| After 128 primary outcome events (approx 4 years) |
| Occurence of all-cause stroke | After 128 primary outcome events (approx 4 years) |
| Rate of all-cause mortality | After 128 primary outcome events (approx 4 years) |
| Rate of cardiovascular mortality | After 128 primary outcome events (approx 4 years) |
| Occurence of minor bleeding | All types of bleeding leading to hospital contact | After 128 primary outcome events (approx 4 years) |
| Number of participants who receive blood transfusion | After 128 primary outcome events (approx 4 years) |
| Occurence of myocardial infarction | After 128 primary outcome events (approx 4 years) |
| Occurence of deep venous thrombosis | After 128 primary outcome events (approx 4 years) |
| Occurence of pulmonary embolism | After 128 primary outcome events (approx 4 years) |
| Health-related Quality of Life (HRQOL) | EQ-5D-5L (EuroQol-5 Dimensions-5 Levels) score to evaluate generic HRQOL (0-100). Higher scores mean better quality of life. | Baseline (day 0) and 1 and 2 years after inclusion |
| Patient-reported satisfaction with overall medical treatment | Treatment Satisfaction Questionnaire (TSQM) to evaluate satisfaction related to their overall medical treatment. TSQM scoring is by domain and each domain score is computed by summing the individual TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100. Higher scores indicate higher patient satisfaction with medication. | Baseline (day 0) and 1 and 2 years after inclusion |
| Patient-reported satisfaction with anticoagulant treatment | Anti-Clot Treatment Scale (ACTS) questionnaire to evaluate satisfaction related to oral anticoagulant treatment. The ACTS Burdens total score ranges from 12 to 60, and the ACTS Benefits total score ranges from 3 to 15. Higher ACTS Burdens and Benefits scores indicate greater satisfaction with treatment. | Baseline (day 0) after inclusion |
| Gentofte Hospital | Recruiting | Gentofte Municipality | Capital Region | Denmark |
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| Regionshospital Gødstrup | Not yet recruiting | Herning | Central Jutland | Denmark |
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| Aalborg university hospital | Not yet recruiting | Aalborg | North Denmark | Denmark |
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| Århus Universitetshospital | Recruiting | Aarhus | Region Midt | Denmark |
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| Odense University Hospital | Recruiting | Odense | Region Syddanmark | Denmark |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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