Prevention of Stroke in Survivors of Brain Bleeding with Atrial Fibrillatio

Phase 1

• Conditions: Ischaemic stroke prevention in patients with atrial fibrillation and previous intracerebral haemorrhage; MedDRA version: 20.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 22.1Level: LLTClassification code 10067816Term: Cardioembolic strokeSystem Organ Class: 100000004852; MedDRA version: 20.1Level: LLTClassification code 10055815Term: Haemorrhage intracerebralSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-002176-41-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-30
• Last Update Posted: 3 August 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 654

Inclusion Criteria

1. Age = 18 years
2. Written informed consent
3. Recent history of a non-traumatic spontaneous ICH during the 6 months before enrolment
4. Documented evidence of AF (paroxysmal, persistent or permanent)
CHA2DS2-VASc score=2 for male, and CHA2DS2-VASc score= 3 for female patients
5. Availability of brain imaging following the index Intracerebral Haemorrhage (ICH)

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 554

Exclusion Criteria

1. Patient lacks capacity to consent
2. Fully dependent (defined as a modified Rankin Scale score of over 4)
3. Women who are pregnant, breastfeeding, or plan to become pregnant during the Study period
4. Women of childbearing potential (WOCBP) who are unable or unwilling to take measures for effective contraception
5. ICH occurring within the last 14 days before enrolment
6. ICH occurring longer than 6 months before enrolment
7. ICH resulting from trauma or vascular malformation
8. Another indication for long-term anticoagulation
9. Patient has hypertension, which in the opinion of the investigator, is uncontrollable with medication
10. Any contraindication (except intracerebral haemorrhage) to treatment with apixaban, dabigatran, edoxaban, rivaroxaban as per SmPC. Including any of the following:
oHypersensitivity to the active principle or any of the excipients

oClinically relevant bleeding in progress

oLiver disease associated with coagulopathy and a clinically relevant bleeding risk

oInjuries or conditions such as a significant risk of major bleeding

oHepatic impairment or liver disease which can have an impact on survival

oExclusion of patients with end-stage renal creatinine clearance CrCL, (CrCL <15 ml / min) or in patients undergoing dialysis

oConcomitant treatment with other anticoagulants
oPatients with a history of thrombosis and antiphospholipid antibody syndrome
Special warnings and precautions for use for apixaban, dabigatran, edoxaban, rivaroxaban as per SmPC should also be taken into account at randomisation.

11. Absolute need for antiplatelet agent (APA) at enrolment, meaning that a patient randomised to receive DOAC who would require an APA is not eligible (single APA is permitted in control group only, at time of randomisation).
12. Presence of a left atrial appendage occlusion device (LAAO) or plan to implant an LAAO
13. Presence of any medical, psychological, or psychiatric condition which in the opinion of the Principal or Co-Investigator would cause participation in the Study to be unwise
14. Participation in any clinical study with an Investigational Medicinal Product within the past 30 days or 5 half-lives of the study drug(observational studies are permitted)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified