Ischaemic stroke prevention in patients with atrial fibrillation and previous intracerebral haemorrhage MedDRA version: 20.0 Level: LLT Classification code 10003661 Term: Atrial fibrillation paroxysmal System Organ Class: 100000004849 MedDRA version: 20.0 Level: LLT Classification code 10034039 Term: Paroxysmal atrial fibrillation System Organ Class: 100000004849 MedDRA version: 20.0 Level: LLT Classification code 10066551 Term: Chronic atrial fibrillation System Organ Class: 100000004849 Me
Conditions
Interventions
Trade Name: Eliquis 2,5mg Filmtabletten
Product Name: Eliquis
Product Code: B01AF02
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: APIXABAN
CAS Number: 503612-47-3
Current Sponsor code:
Sponsors
Imperial College of Science Technology and Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years 2. Written informed consent from the patient or legal representative 3. Recent history of a non-traumatic spontaneous ICH during the 12 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: 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
Exclusion criteria: 1. Fully dependent (defined as a modified Rankin Scale score of over 4) 2. Women who are pregnant, breastfeeding, or plan to become pregnant during the Study period 3. Women of childbearing potential (WOCBP) who are unable or unwilling to take measures for effective contraception 4. ICH occurring within the last 14 days before enrolment 5. ICH occurring longer than 12 months before enrolment 6. ICH resulting from trauma or vascular malformation 7. Another indication for long-term anticoagulation 8. Contraindication for long-term anticoagulant therapy with DOACs (other than ICH) 9. Absolute need for antiplatelet therapy at enrolment 10. Presence of a left atrial appendage occlusion device (LAAO) or plan to implant an LAAO 11. 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 12. Participation in any clinical study with an Investigational Medicinal Product within the past 30 days (observational studies are permitted)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Do particular anti-clotting drugs called direct oral anticoagulants reduce the rate of ischaemic stroke, that is strokes caused by a blood clot blocking a blood vessel, compared to no anticoagulation (control group) without unacceptably increasing the risk of recurrent brain bleeds in patients with atrial fibrillation and a previous brain bleed within 12 months before enrolment.;Secondary Objective: 1. To examine the effect of anticoagulation with DOAC versus no anticoagulation on major cardiovascular outcomes and mortality in ICH patient with AF. Cardiovasular outcomes include stroke, embolism attributed to blood clot formation, death of any cause or attributed to cardiovascular causes and major adverse cardiac events such as death, cardiac stent thrombosis, recurrent heart attacks. 2.To compare the effect of DOACs versus no anticoagulation on major systemic and intracranial bleeding in this Study population (safety) 3. To examine the effect of DOACs versus no anticoagulation on net clinical benefit in ICH patients with AF. Net clinical benefit is defined as composite of all stroke, e mbolic events attributed to blood clots, heart attack, death attributed to cardiovascular causes, and massive bleeding. 4. To explore the impact of DOAC vs. no anticoagulation on quality of life, cognition and psychological morbidity in patients with ICH and AF over time;Primary end point(s): There are two co-primary binary endpoints in the Study (evaluated by time-to-event analysis): Ischaemic stroke and recurrent intracerebral haemorrhage. The Study will perform hierarchical testing of the two co-primary endpoints in a parallel group design.;Timepoint(s) of evaluation of this end point: Anytime during follow-up period the end points will be evaluated and adjudicated | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints are 1. all stroke and systemic embolism 2. all-cause mortality 3. cardiovascular mortality 4. major adverse cardiac events 5. net clinical benefit defined as composite endpoint of all stroke, systemic embolic event, myocardial infarction, cardiovascular mortality, and major bleeding Secondary safety endpoints comprise of 1. any major haemorrhage according to International Society of Thrombosis and Hemostasis (ISTH) bleeding assessment tool 2. any intracranial haemorrhage Timepoint(s) of evaluation of this end;Timepoint(s) of evaluation of this end point: Anytime during follow-up period the end points will be evaluated and adjudicated | — |
Countries
Austria, France, Germany, Italy, Spain, United Kingdom
Contacts
Public ContactDivision of Brain Sciences
Imperial College of Science, Technology and Medicine in London
Outcome results
None listed