Prevention of Stroke in Survivors of Brain Bleeding with Atrial Fibrillation

PREvention of STroke in Intracerebral haemorrhaGE survivors with Atrial Fibrillation (PRESTIGE-AF) - PRESTIGE-AF

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002176-41-ES

Enrollment

654

Registered

2019-04-12

Start date

2019-06-18

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischaemic stroke prevention in patients with atrial fibrillation and previous intracerebral haemorrhage

Interventions

Trade Name: Eliquis Product Name: Eliquis Pharmaceutical Form: Film-coated tablet INN or Proposed INN: APIXABAN Other descriptive name:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age = 18 years 2. Ability to provide informed consent 3. Recent history of a non-traumatic spontaneous ICH within 15 days to 6 months before enrolment 4. Presence of AF (paroxysmal, persistent, permanent) 5. CHA2DS2-VASc score =2 for male and CHA2DS2-VASc score =3 for female patients [15]. 6. Availability of a brain scan performed after the ICH and before enrolment 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. Patient lacks the capacity to consent 2. Fully dependent (modified Rankin scale >4) 3. Women who are pregnant, breastfeeding or planning on becoming pregnant 4. Women of childbearing potential (WOCBP 12.1) who are unable or unwilling to take measures for effective contraception (4.8) 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. Indication for long-term anticoagulation other than AF 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 Summary of Product Charasteristics (SmPC) 11. Absolute need for antiplatelet therapy at enrolment 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 (observational studies are permitted)

Design outcomes

Primary

Measure	Time frame
Primary end point(s): There are two co-primary binary endpoints in the Study (evaluated by time-to-event analysis): IS and recurrent ICH. The Study will perform hierarchical testing of the two co-primary endpoints in a parallel group design;Main Objective: The main objective is to perform a RCT to resolve the long-standing management dilemma of antithrombotic stroke prevention in intracerebral haemorrhage (ICH) survivors with comorbid atrial fibrillation (AF). Specifically, it will address the question whether direct oral anticoagulants (DOACs, intervention) provide a more effective option for prevention of ischaemic stroke (IS) and an equally safe option in terms of recurrence of ICH for antithrombotic stroke prevention in survivors of recent ICH compared to no anticoagulation (i.e. no antithrombotic therapy (noAT) or antiplatelet therapy (APA) at Principal Investigator´s discretion).; 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 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 net clinical benefit of DOACs vs no anticoagulation in ICH patients with AF 4. To explore the impact of antithrombotic therapy on quality of life, development of cognitive deficits and psychological morbidity in patients with ICH and AF over time ;Timepoint(s) of evaluation of this end point: Anytime during follow-up period the end points will be evaluated and adjudicated	—

Measure

Time frame

Primary end point(s): There are two co-primary binary endpoints in the Study (evaluated by time-to-event analysis): IS and recurrent ICH. The Study will perform hierarchical testing of the two co-primary endpoints in a parallel group design;Main Objective: The main objective is to perform a RCT to resolve the long-standing management dilemma of antithrombotic stroke prevention in intracerebral haemorrhage (ICH) survivors with comorbid atrial fibrillation (AF). Specifically, it will address the question whether direct oral anticoagulants (DOACs, intervention) provide a more effective option for prevention of ischaemic stroke (IS) and an equally safe option in terms of recurrence of ICH for antithrombotic stroke prevention in survivors of recent ICH compared to no anticoagulation (i.e. no antithrombotic therapy (noAT) or antiplatelet therapy (APA) at Principal Investigator´s discretion).; 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 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 net clinical benefit of DOACs vs no anticoagulation in ICH patients with AF 4. To explore the impact of antithrombotic therapy on quality of life, development of cognitive deficits and psychological morbidity in patients with ICH and AF over time ;Timepoint(s) of evaluation of this end point: Anytime during follow-up period the end points will be evaluated and adjudicated

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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 [14]. 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 point: Anytime during follow-up period the end points will be evaluated and adjudicated	—

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 [14]. 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 point: Anytime during follow-up period the end points will be evaluated and adjudicated

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Countries

Germany, Spain

Contacts

Public ContactGisela Pereira Barreto

Imperial College of Science, Technology and Medicine

g.pereira-barreto@imperial.ac.uk02075949480

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026