Left Atrial Appendage Occlusion Versus Novel Oral Anticoagulation for Stroke Prevention in Atrial Fibrillation. A Multicenter Randomized Clinical Trial. (Occlusion-AF)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 750
- 试验地点
- 15
- 主要终点
- Composite endpoint of stroke (ischemic and hemorrhagic), systemic embolism, major bleeding and all-cause mortality.
研究概览
简要总结
Atrial fibrillation (AF) is progressively common, and increases the risk of stroke five-fold. Oral anticoagulation is the mainstay therapy; however, it increases the risk of bleeding. Moreover, 30% with AF and at risk of stroke are not in relevant anticoagulation. The randomized PROTECT-AF trial has demonstrated the superiority of left atrial appendage occlusion (LAAO) as compared to warfarin for prevention of the combined endpoint of stroke, major bleeding and cardiovascular mortality. However, studies comparing LAAO to therapy with novel oral anticoagulants (NOAC) have not been carried out.
This study aims to assess the effect of left atrial appendage occlusion (LAAO) to reduce the incidence of stroke, systemic embolism, major bleeding and all-cause mortality in patients with atrial fibrillation (AF) and a prior ischemic stroke or transient ischemic attack (TIA).
详细描述
An investigator-initiated multicenter, randomized open-label non-inferiority trial with blinded outcome evaluation (PROBE design). The active comparison LAAO is tested against NOAC therapy in a 1:1 stratified randomization. Patients should have AF, and an ischemic stroke or TIA within 6 months prior to enrollment. In total 750 patients will be included. Follow-up will be based on in-office and telephone follow-up during the first 3 years after randomization, along with up to 10 years long-term follow-up through the National Patient Registries.
The main study outcomes: The primary outcome is a composite of stroke (hemorrhagic or ischemic), systemic embolism, major bleeding or all-cause mortality assessed after at least two years follow-up for the last enrolled patient. Secondary outcomes will examine early and late safety outcome measures. The long-term outcome will be assessed up to 10-years after randomization through the National Patient Registries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Open-label study with blinded outcome assessment by an independent clinical event committee
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
- •documented non-valvular atrial fibrillation (paroxysmal, persistent or permanent)
- •Eligible for long-term Novel Oral Anticoagulation (NOAC) therapy
- •Ischemic stroke within the recent 6 months verified by neuroimaging, or
- •Transient ischemic attack within 6 months with proven cerebral ischemia based on cerebral magnetic resonance imaging (MRI)
排除标准
- •Modified rankin scale > 3 at time of enrollment
- •Glomerular filtration rate (GFR) below 15 ml/min/1.73 m2
- •Contraindication towards long-term aspirin therapy
- •Planned combined cardiovascular interventional procedures at the time of enrollment
- •Terminal illness or cancer with life expectancy less than 2 years.
研究组 & 干预措施
LAAO group
Patients will be treated with transcatheter left atrial appendage occlusion. The LAAO may be performed with the Amulet or Watchman device.
干预措施: Left atrial appendage occlusion (Device)
NOAC group
Patients will be treated with one of the currently available NOAC drugs; Apixaban, Dabigatran, Edoxaban or Rivaroxaban.
干预措施: NOAC (Drug)
结局指标
主要结局
Composite endpoint of stroke (ischemic and hemorrhagic), systemic embolism, major bleeding and all-cause mortality.
时间窗: Up to 5-years from randomization
The primary endpoint is the combined rate of stroke, systemic embolism, major bleeding and all-cause mortality.
次要结局
- Incidence of systemic embolism(2-, 3-, 5- and 10-years)
- Number of patients with technical success(2 Months)
- Number of patients with a procedure-related complication(2 months)
- Number of patients with peri-device leaks at follow-up imaging(2 months)
- Compliance to NOAC(2-, 3-, 5-, and 10-years)
- Incidence of major or life-threatening bleeding(2-, 3-, 5- and 10-years)
- Number of patients with a device success(2 months)
- Number of patients with procedural success(2 months)
- Changes in neurological status based on National Institute of Health (NIH) Stroke scale score(12 months)
- Incidence of ischemic stroke(2-, 3-, 5- and 10-years)
- Incidence of hemorrhagic stroke(2-, 3-, 5- and 10-years)
- Incidence of all-cause mortality(2-, 3-, 5- and 10-years)
- Incidence of Transient ischemic attack (TIA)(2-, 3-, 5- and 10-years)
- Number of patients with a device-related complication(2 months)
- Changes in Quality of life(12 months)
- Changes in functional status based on Modified Rankin Scale(24 months)