EdoxabaN foR IntraCranial Hemorrhage Survivors With Atrial Fibrillation (ENRICH-AF)

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess whether edoxaban (60/30 mg daily) compared to non-antithrombotic medical therapy (either no antithrombotic therapy or antiplatelet monotherapy) reduces the risk of stroke (composite of ischemic, hemorrhagic and unspecified stroke) in high-risk atrial fibrillation (CHA2DS2-VASc ≥2) patients with previous intracranial hemorrhage.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Population Health Research Institute
• Treatments: Edoxaban

Criteria

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, and confirmed to have stabilized on neuroimaging.

4. Documented atrial fibrillation (paroxysmal, persistent, permanent)

5. CHA2DS2-VASc score ≥2

Exclusion Criteria:

1. Recent intracranial 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).