Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Atrial Fibrillation Occurring Transiently With Stress - The ASPIRE-AF Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 2,270
- 试验地点
- 193
- 主要终点
- Incidence of vascular mortality, and non-fatal non-hemorrhagic stroke, myocardial infarction, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism
研究概览
简要总结
Multinational, investigator-initiated study of oral anticoagulation versus no anticoagulation for the prevention of stroke and other adverse cardiovascular events in patients with transient atrial fibrillation occurring transiently with stress and additional stroke risk factors.
详细描述
ASPIRE-AF is a prospective, randomized, open-label trial of non-vitamin K oral anticoagulants (NOACs) versus no oral anticoagulation in patients with transient atrial fibrillation and additional stroke factors occurring transiently with stress. The primary objective is to assess the effects of NOACs versus no anticoagulation on the co-primary composite outcomes of 1. non-hemorrhagic stroke and systemic embolism, and 2. vascular mortality, and non-fatal non-hemorrhagic stroke, myocardial infarction, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism over the duration of follow-up.
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)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have ≥1 episode of clinically important AFOTS during any of the following conditions:
- •noncardiac surgery in the past 35 days, with at least an overnight hospital admission aftersurgery;
- •noncardiac day surgery resulting in a large enough physiological insult to be able to cause AFOTS, as judged by the local investigator; or
- •acute medical illness requiring hospital admission in the past 35 days and resulting in a large enough physiological insult to be able to cause AFOTS, as judged by the local investigator;
- •sinus rhythm at the time of randomization;
- •any of the following high-risk criteria:
- •age 55-64 years, and having either known cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥3, or an elevated postoperative troponin level;
- •age 65-74 years, and having either known cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥2, or an elevated postoperative troponin level; OR
- •age ≥75 years.;
- •provide written informed consent
排除标准
- •any cardiac diagnosis as the primary reason for hospital admission;
- •history of documented chronic AF prior to noncardiac surgery;
- •need for long-term systemic anticoagulation;
- •ongoing need for long-term dual antiplatelet treatment;
- •contraindication to oral anticoagulation;
- •severe renal insufficiency (CrCl <20 ml/min);
- •severe liver cirrhosis (i.e., Child-Pugh Class C)
- •acute stroke in the past 14 days;
- •underwent cardiac surgery in the past 35 days;
- •history of nontraumatic intracranial, intraocular, or spinal bleeding;
- •hemorrhagic disorder or bleeding diathesis;
- •expected to be non-compliant with follow-up and/or study medications;
- •known life expectancy less than 1 year due to concomitant disease;
- •women who are pregnant, breastfeeding, or of childbearing potential who are not taking effective contraception; OR
- •previously enrolled in the trial
研究组 & 干预措施
Non-vitamin K oral anticoagulant (NOAC)
Participants randomized to the intervention arm will be prescribed one of the following NOACs for the duration of follow-up, unless they are undergoing a procedure with an increased risk of bleeding, have an adverse event or low calculated creatinine clearance, or decide to discontinue their use.
干预措施: Non-vitamin K oral anticoagulant (NOAC) (Drug)
结局指标
主要结局
Incidence of vascular mortality, and non-fatal non-hemorrhagic stroke, myocardial infarction, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism
时间窗: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Incidence of Non-hemorrhagic stroke or systemic embolism
时间窗: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
次要结局
- Incidence of vascular mortality(For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months))
- Incidence of non-fatal, non-hemorrhagic stroke(For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months))
- Incidence of peripheral arterial thrombosis(For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months))
- Incidence of all-cause mortality(For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months))
- Incidence of Myocardial infarction(For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months))
- Incidence of symptomatic venous thromboembolism(For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months))
- Incidence of all-cause stroke(For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months))
- Incidence of amputation(For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months))