Reduction in the risk of stroke in people who have both a previous intracranial bleed and atrial fibrillatio

Phase 1

• Conditions: High risk atrial fibrillation patients with previous intracranial hemorrhage; MedDRA version: 21.1Level: PTClassification code 10018985Term: Haemorrhage intracranialSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2019-002075-33-CZ
• Lead Sponsor: Hamilton Health Sciences, through its Population Health Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-14
• Last Update Posted: 21 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1200

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 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 clinical trial of medicinal product
• Study Design: Not specified