Study to prevent Stroke in patients with history of Brain Hemorrhage and Atrial Fibrillatio

Phase 3

• Conditions: Health Condition 1: I629- Nontraumatic intracranial hemorrhage, unspecifiedHealth Condition 2: I489- Unspecified atrial fibrillation and atrial flutter

• Registration Number: CTRI/2020/11/029418
• Lead Sponsor: Hamilton Health Sciences through its Populatio Health Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified