EUCTR2018-002176-41-DE进行中（未招募）1 期
PREvention of STroke in Intracerebral haemorrhaGE survivors with Atrial Fibrillation (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 from the patient or legal representative
- •3. Recent history of a non-traumatic spontaneous ICH during the 12 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
- •1. Fully dependent (defined as a modified Rankin Scale score of over 4)
- •2. Women who are pregnant, breastfeeding, or plan to become pregnant during the Study period
- •3. Women of childbearing potential (WOCBP) who are unable or unwilling to take measures for effective contraception
- •4. ICH occurring within the last 14 days before enrolment
- •5. ICH occurring longer than 12 months before enrolment
- •6. ICH resulting from trauma or vascular malformation
- •7. Another indication for long-term anticoagulation
- •8. Contraindication for long-term anticoagulant therapy with DOACs (other than ICH)
- •9. Absolute need for antiplatelet therapy at enrolment
- •10. Presence of a left atrial appendage occlusion device (LAAO) or plan to implant an LAAO
- •11. 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
- •12. 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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