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EdoxabaN foR IntraCranial Hemorrhage survivors with Atrial Fibrillation
EU CTIS ID: 2024-518508-31-00
What this study is testing
To assess whether edoxaban (60/30 mg daily) compared to nonanticoagulant medical therapy (either no antithrombotic therapy or antiplatelet monotherapy) reduces the composite risk of stroke (ischemic, hemorrhagic and unspecified stroke) or systemic embolism in high-risk atrial fibrillation (CHA2DS2-VASc score =/>2) participants with previous intracranial hemorrhage.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 non-lobar intraparenchymal or intraventricular hemorrhage, 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
You likely can't join if
- Recent intracranial hemorrhage (within 14 days)
- Chronic use of NSAID
- Clinically significant active bleeding, including gastrointestinal bleeding
- 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
- Antiphospholipid antibody syndrome
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
See the full eligibility 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 non-lobar intraparenchymal or intraventricular hemorrhage, 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
- Recent intracranial hemorrhage (within 14 days)
- Chronic use of NSAID
- Clinically significant active bleeding, including gastrointestinal bleeding
- 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
- Antiphospholipid antibody syndrome
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
- Known hypersensitivity to edoxaban
- Estimated inability to adhere to study procedures
- Pregnancy or breastfeeding
- Estimated life expectancy < 6 months at the time of enrollment
- 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)
- Secondary macrovascular, neoplastic or infectious causes of intracranial hemorrhage (except for antithrombotic treatment or non- penetrating traumatic subdural hemorrhages)
- Lobar intraparenchymal hemorrhages
- * 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).
- Isolated subarachnoid hemorrhage (convexity or basal); subarachnoid blood tracking onto convexity secondary to an intraventricular hemorrhage or as part of a multicompartment bleed in cases of traumatic subdural hemorrhages are eligible
- Need for ongoing oral anticoagulant therapy for indication other than AF (e.g. mechanical heart valve, venous thromboembolic disease)
- Need for ongoing antiplatelet therapy for indication where edoxaban would not be a suitable substitute
- Plans for left atrial appendage occlusion
- Estimated creatinine clearance (CrCl) < 15 mL/min or other creatinine clearance following local product monograph (Canada < 30mL/min)
- Platelet count less than 100,000mm3 at enrollment or other bleeding diathesis
- Persistent, uncontrolled hypertension (systolic BP averaging >150 mmHg)
The study team makes the final eligibility decision.
Where it's taking place
- India
- Switzerland
- Egypt
- Argentina
- Sri Lanka
- United Kingdom
- China
- Canada
- Nepal
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include India; Switzerland; Egypt; Argentina; Sri Lanka; United Kingdom and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.