Non-Vitamin K Antagonist Oral Anticoagulants for Stroke Prevention in Patients With Atrial Fibrillation and Previous Intracerebral Hemorrhage Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 9
- 主要终点
- Recruitment rate
研究概览
简要总结
To determine the feasibility of a controlled trial examining the efficacy and safety of non-vitamin K antagonist oral anticoagulants (NOACs) compared with ASA for stroke prevention in patients with a high-risk of atrial fibrillation and previous intracerebral hemorrhage.
详细描述
The NASPAF-ICH study is an open-label, randomized, controlled, phase II study that will assess the feasibility of a controlled trial examining the efficacy and safety of non-vitamin K antagonist oral anticoagulants (NOACs) compared with acetylsalicylic acid (ASA) for stroke prevention in patients with high-risk atrial fibrillation and previous intracerebral hemorrhage, as well as provide evidence of efficacy and safety for planning of a phase III trial. Recruitment will occur at 10 high-volume stroke research centres across Canada over 2 years, at which 100 adult patients with high-risk atrial fibrillation (CHADS2 ≥2) and previous spontaneous or traumatic ICH (intraparenchymal or intraventricular hemorrhage while on or off anticoagulation) will be randomly assigned to receive a NOAC (particular agent at the discretion of the local investigator) or ASA 81 mg per day. Patients will be followed for a mean of 1 year to a common end-study date. The feasibility of recruitment will also be tested. The investigators estimate that five patients per year per centre can be recruited.
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)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous primary intracerebral hemorrhage
- •Atrial fibrillation (CHADS2 ≥ 2)
排除标准
- •Non-stroke indication for antiplatelet or anticoagulant therapy
- •Recent intracerebral hemorrhage within 14 days
- •Platelet count less than 100,000/mm3 at enrollment or other bleeding diathesis
- •Prior symptomatic lobar intracerebral hemorrhage other than the qualifying event
- •Uncontrollable hypertension consistently above SBP/DBP of 160/100 mmHg
- •Known hypersensitivity to either ASA or NOACs
- •Inability to adhere to study procedures
研究组 & 干预措施
NOAC
Apixaban or dabigatran or edoxaban or rivaroxaban
干预措施: NOAC (Drug)
Acetylsalicylic Acid
Acetylsalicylic acid
干预措施: Acetylsalicylic Acid (Drug)
结局指标
主要结局
Recruitment rate
时间窗: Through study completion; ~ 30 months
The mean number of patients randomized per site per year.
Composite of ischemic stroke and recurrent intracerebral hemorrhage
时间窗: Through study completion; average of 1 year
The composite of ischemic stroke and recurrent intracerebral hemorrhage
次要结局
- Retention rate(Through study completion; average of 1 year)
- Major hemorrhage(Through study completion; average of 1 year)
- Ischemic stroke(Through study completion; average of 1 year)
- Fatal stroke(Through study completion; average of 1 year)
- Myocardial infarction(Through study completion; average of 1 year)
- All-cause mortality(Through study completion; average of 1 year)
- Intracranial hemorrhage(Through study completion; average of 1 year)
- Montreal Cognitive Assessment (MOCA)(Through study completion; average of 1 year)
- Refusal rate(Through study completion; average of 1 year)
- Intracerebral hemorrhage(Through study completion; average of 1 year)
- Systemic thromboembolism(Through study completion; average of 1 year)
- Composite of all stroke, myocardial infarct, systemic thromboembolism or death(Through study completion; average of 1 year)
- Modified Rankin Scale (mRS)(Through study completion; average of 1 year)
研究者
Ashkan Shoamanesh
Assistant Professor of Medicine (Neurology)
Population Health Research Institute