EUCTR2018-002176-41-ES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
入选标准
- •1. Age = 18 years
- •2. Ability to provide informed consent
- •3. Recent history of a non-traumatic spontaneous ICH within 15 days to 6 months before enrolment
- •4. Presence of AF (paroxysmal, persistent, permanent)
- •5. CHA2DS2-VASc score =2 for male and CHA2DS2-VASc score =3 for female patients [15].
- •6. Availability of a brain scan performed after the ICH and before enrolment
- •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. Patient lacks the capacity to consent
- •2. Fully dependent (modified Rankin scale >4)
- •3. Women who are pregnant, breastfeeding or planning on becoming pregnant
- •4. Women of childbearing potential (WOCBP 12.1) who are unable or unwilling to take measures for effective contraception (4.8)
- •5. ICH occurring within the last 14 days before enrolment
- •6. ICH occurring longer than 6 months before enrolment
- •7. ICH resulting from trauma or vascular malformation
- •8. Indication for long-term anticoagulation other than AF
- •9. Patient has hypertension, which in the opinion of the investigator, is uncontrollable with medication
- •10. Any contraindication (except intracerebral haemorrhage) to treatment with apixaban, dabigatran, edoxaban, rivaroxaban as per Summary of Product Charasteristics (SmPC)
- •11. Absolute need for antiplatelet therapy at enrolment
- •12. Presence of a left atrial appendage occlusion device (LAAO) or plan to implant an LAAO
- •13. 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
- •14. 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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