EUCTR2018-002176-41-GB进行中（未招募）1 期
PREvention of STroke in Intracerebral haemorrhaGE survivors with Atrial Fibrillation (PRESTIGE-AF) - PRESTIGE-AF
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: 0
- •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 capacity to consent
- •2. Fully dependent (defined as a modified Rankin Scale score of over 4)
- •3. Women who are pregnant, breastfeeding, or plan to become pregnant during the Study period
- •4. Women of childbearing potential (WOCBP) who are unable or unwilling to take measures for effective contraception
- •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. Another indication for long-term anticoagulation
- •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 SmPC. Including any of the following:
- •oHypersensitivity to the active principle or any of the excipients
- •oClinically relevant bleeding in progress
- •oLiver disease associated with coagulopathy and a clinically relevant bleeding risk
- •oInjuries or conditions such as a significant risk of major bleeding
- •oHepatic impairment or liver disease which can have an impact on survival
- •oExclusion of patients with end-stage renal creatinine clearance CrCL, (CrCL <15 ml / min) or in patients undergoing dialysis
- •oConcomitant treatment with other anticoagulants
- •oPatients with a history of thrombosis and antiphospholipid antibody syndrome
- •Special warnings and precautions for use for apixaban, dabigatran, edoxaban, rivaroxaban as per SmPC should also be taken into account at randomisation.
- •11. Absolute need for antiplatelet agent (APA) at enrolment, meaning that a patient randomised to receive DOAC who would require an APA is not eligible (single APA is permitted in control group only, at time of randomisation).
- •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 or 5 half-lives of the study drug(observational studies are permitted)
研究者
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