PREvention of STroke in Intracerebral haemorrhaGE Survivors With Atrial Fibrillation (PRESTIGE-AF)
Atrial Fibrillation, Intracerebral Hemorrhage
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Arrhythmias, Cardiac, Cerebral Hemorrhage, Brain haemorrhage, Intracerebral hemorrhage, Cerebral haemorrhage, Basal ganglia haemorrhage, Putaminal haemorrhage, Anticoagulants, Oral anticoagulant, Direct oral anticoagulant, New oral anticoagulant, Factor Xa inhibitors, Direct thrombin inhibitor, Dabigatran, Apixaban, Rivaroxaban, Edoxaban, DOAC, NOAC, Intracerebral haemorrhage, Brain hemorrhage
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Written informed consent
- Recent history of a non-traumatic spontaneous intracerebral haemorrhage during the 6 months before enrolment
- Documented evidence of Atrial Fibrillation (paroxysmal, persistent or permanent)
- CHA2DS2-VASc score≥2 for male, and CHA2DS2-VASc score≥ 3 for female patients
- Availability of brain imaging following the index intracerebral haemorrhage
Exclusion Criteria:
- Patient lacks capacity to consent
- Fully dependent (Modified Rankin Scale Score >4)
- Women who are pregnant, breastfeeding, or plan to become pregnant during the Study period
- Women of childbearing potential who are unable or unwilling to take measures for effective contraception
- Intracerebral haemorrhage occurring within the last 14 days before enrolment
- Intracerebral haemorrhage occurring longer than 6 months before enrolment
- Intracerebral haemorrhage resulting from trauma or vascular malformation
- Another indication for long-term anticoagulation
- Patient has hypertension, which in the opinion of the investigator, is uncontrollable with medication
- Any contraindication (except intracerebral haemorrhage) to treatment with apixaban, dabigatran, edoxaban, rivaroxaban as per summary of product characteristics (SmPC).
- Absolute need for antiplatelet therapy at enrolment
- Presence of a left atrial appendage occlusion device (LAAO) or plan to implant an LAAO
- 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
- Participation in any clinical study with an Investigational Medicinal Product within the past 30 days (observational studies are permitted)
Sites / Locations
- Klinikum Altenburger LandRecruiting
- Vivantes Hospital NeukolinRecruiting
- University Hospital CologneRecruiting
- University Hospital ErlangenRecruiting
- Alfried Krupp Von Bohlen und Halbach-KrankenhausRecruiting
- University Hospital FrankfurtRecruiting
- Bezirkskrankenhaus GünzburgRecruiting
- Medizinische Hochschule HannoverRecruiting
- University Hospital HeidelbergRecruiting
- University Hospital Schleswig-Holstein Campus Kiel
- University of LeipzigRecruiting
- University Hospital Schleswig-Holstein Campus LuebeckRecruiting
- Johannes Wesling Klinikum Minden
- Hospital Germans Trias I PujolRecruiting
- Hospital Dr Josep TruetaRecruiting
- East Kent Hospitals University NHS Foundation TrustRecruiting
- Northumbria Healthcare NHS Foundation Trust
- Basildon and Thurrock University Hospitals NHS TrustRecruiting
- Cambridge University Hospitals NHS TrustRecruiting
- Hull and East Yorkshire NHS TrustRecruiting
- Kings College Hospital NHS Foundation TrustRecruiting
- Imperial College Healthcare NHS TrustRecruiting
- Royal Free London NHS Foundation Trust
- University Hospitals Plymouth NHS Trust
- St Helens and Knowsley Teaching Hospital NHS Trust
- Taunton and Somerset NHS Foundation TrustRecruiting
- Mid Yorkshire Hospitals NHS TrustRecruiting
- West Hertfordshire Hospitals NHS TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Direct Oral Anticoagulant
No Anticoagulant
If the patient is randomized in this arm, a direct oral anticoagulant (DOAC) included: Direct thrombin inhibitor: Dabigatran Factor Xa inhibitors: Apixaban or Rivaroxaban or Edoxaban will be prescribed to the patient. Choice and dose of DOAC treatment as well as the use of concomitant medication during the study treatment will be at the Principal Investigator´s discretion within the spectrum of licensed doses labelled for stroke prevention in atrial fibrillation patients in Europe following the Summary of Product Characteristics.
If the patient is randomized in this arm investigators will use their best judgment to decide upon the prescription of an antiplatelet drug of their choice or no such therapy