EUCTR2018-002176-41-FR进行中（未招募）1 期
PREvention of STroke in Intracerebral haemorrhaGE survivors with Atrial Fibrillation (PRESTIGE-AF) - PRESTIGE-AF
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 654
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age = 18 years
- •2. Written informed consent
- •3. Recent history of a non-traumatic spontaneous ICH during the 6 months before enrolment
- •4. Documented evidence of AF (paroxysmal, persistent or permanent)
- •CHA2DS2-VASc score=2 for male, and CHA2DS2-VASc score= 3 for female patients
- •5. Availability of brain imaging following the index Intracerebral Haemorrhage (ICH)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 554
排除标准
- •Patient lacks the capacity to consent
- •Fully dependent (modified Rankin scale >4)
- •Women who are pregnant, breastfeeding or planning on becoming pregnant
- •Women of childbearing potential (WOCBP 12.1) who are unable or unwilling to take measures for effective contraception (4.8)
- •ICH occurring within the last 14 days before enrolment
- •ICH occurring longer than 6 months before enrolment
- •ICH resulting from trauma or vascular malformation
- •Indication for long-term anticoagulation other than AF
- •Patient has hypertension, which in the opinion of the investigator, is uncontrollable with medication
- •Any contraindication (except intracerebral haemorrhage) to treatment with apixaban, dabigatran, edoxaban, rivaroxaban as per Summary of Product Charasteristics (SmPC). Special warnings and precautions for use for apixaban, dabigatran, edoxaban, rivaroxaban as per SmPC should also be taken into account at randomization.”
- •Absolute need for antiplatelet therapy at enrolment except aspirin or clopidogrel
- •Presence of a left atrial appendage occlusion device (LAAO) or plan to implant an LAAO
- •Presence of any medical, psychological, or psychiatric condition which in the opinion of the Principal or Co-Investigator would cause participation in the Study to be unwise
- •Participation in any clinical study with an Investigational Medicinal Product within the past 30 days (observational studies are permitted)
研究者
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