Anticoagulant Therapy in Patients With Atrial Fibrillation After Surgical Left Atrial Appendage Closure: a Randomized Non-inferiority Trial (The ATLAAC Trial)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 1,220
- 试验地点
- 6
- 主要终点
- Number of participants with ischemic strokes, peripheral arterial embolisms and major bleedings
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Previously undergone any type of cardiac surgical procedure including any type of surgical LAA closure (use of any of the following techniques; amputation and suture closure, stapler closure, non-amputating suture closure or closure with an approved surgical occlusion device (e.g. AtriClip)) according to the NationalPatient Register (NPR), the Danish Heart Registry (DHR) or the Western Danish Heart Registry (WDHR) from January 1st 2010 til 3 months prior to inclusion in the project.
- •Documented history of paroxysmal, persistent, or permanent atrial fibrillation or atrial flutter according to the electronic patient record
- •Informed consent
排除标准
- •Not receiving OAC (warfarin/DOAC)
- •Patient specific conditions requiring OAC (e.g.mechanical valve, previous pulmonary embolism)
- •Renal impairment (estimated glomerular filtration rate < 30)
- •Allergy to contrast media
- •Pregnancy or breastfeeding
研究组 & 干预措施
Discontinue OAC
OAC stopped for the duration of the trial
干预措施: OAC will be discontinued for the duration of the trial (Drug)
结局指标
主要结局
Number of participants with ischemic strokes, peripheral arterial embolisms and major bleedings
时间窗: After 128 primary outcome events (approx 4 years)
Composite endpoint including the occurrence of ischemic stroke, peripheral arterial embolism, and major bleeding (ISTH definition)
次要结局
- Severity of stroke(After 128 primary outcome events (approx 4 years))
- Occurence of transient ischemic attacks(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(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)(Baseline (day 0) and 1 and 2 years after inclusion)
- Patient-reported satisfaction with overall medical treatment(Baseline (day 0) and 1 and 2 years after inclusion)
- Patient-reported satisfaction with anticoagulant treatment(Baseline (day 0) after inclusion)