EUCTR2019-002075-33-ESActive, not recruitingPhase 1
Edoxaban for intracranial hemorrhage survivors with atrial fibrillation - ENRICH-AF: EdoxabaN foR IntraCranial Hemorrhage survivors with Atrial Fibrillation
Hamilton Health Sciences, through its Population Health Research Institute0 sites1,200 target enrollmentStarted: January 10, 2020Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 1,200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1.Written informed consent provided
- •2.Age =45 years, at the time of signing the informed consent
- •3.Previous intracranial hemorrhage (symptomatic, spontaneous and non-traumatic intraparenchymal, intraventricular, and/or cSAH, and symptomatic spontaneous or non-penetrating traumatic subdural hemorrhages) on or off antithrombotic therapy (Table 2)
- •4.Documented atrial fibrillation (paroxysmal, persistent, permanent)
- •5.CHA2DS2-VASc score =2
- •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 240
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 960
Exclusion Criteria
- •1.Recent intracraneal hemorrhage (within 14 days)
- •2.Secondary macrovascular, neoplastic or infectious causes of intracranial hemorrhage (except for antithrombotic treatment or non-penetrating traumatic subdural hemorrhages)
- •3.Traumatic or aneurysmal cSAH
- •4.Need for ongoing oral anticoagulant therapy for indication other than AF (e.g. mechanical heart valve, venous thromboembolic disease)
- •5.Need for ongoing antiplatelet therapy for indication where edoxaban would not be a suitable substitute
- •6.Plans for left atrial appendage occlusion
- •7.Estimated creatinine clearance (CrCl) < 15 mL/min or other creatinine clearance following local product monograph (Canada < 30mL/min)
- •8.Platelet count less than 100,000mm3 at enrollment or other bleeding diathesis
- •9.Persistent, uncontrolled hypertension (systolic BP averaging >150 mmHg)
- •10.Chronic use of NSAID
- •11.Clinically significant active bleeding, including gastrointestinal bleeding
- •12.Lesions or conditions at increased risk of clinically significant bleeding, e.g. active peptic ulcer disease with recent bleeding, patients with spontaneous or acquired impairment of hemostasis
- •13.Antiphospholipid antibody syndrome
- •14.Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
- •15.Known hypersensitivity to edoxaban
- •16.Estimated inability to adhere to study procedures
- •17.Pregnancy or breastfeeding
- •18.Estimated life expectancy < 6 months at the time of enrollment
- •19.Close affiliation with the investigational site; e.g. a close relative for the investigator, dependent person (e.g., employee or student of the investigational site)
- •* Post menopausal female subjects must be amenorrheic for =12 months prior to screening or =6 weeks post-surgical bilateral oophorectomy (with or without hysterectomy) prior to screening. Women of childbearing potential must have negative serum pregnancy test within 7 days prior to randomization or urine pregnancy testing within 24 hours of randomization. Heterosexually active women of childbearing potential must use highly effective methods of contraception for 32 days after discontinuation (duration of study drug plus 30 days duration of one ovulatory cycle).
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