EUCTR2018-002176-41-FR
Active, not recruiting
Phase 1
PREvention of STroke in Intracerebral haemorrhaGE survivors with Atrial Fibrillation (PRESTIGE-AF) - PRESTIGE-AF
ConditionsIschaemic stroke prevention in patients with atrial fibrillation and previous intracerebral haemorrhageMedDRA version: 20.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 21.1Level: LLTClassification code 10067816Term: Cardioembolic strokeSystem Organ Class: 100000004852MedDRA version: 20.1Level: LLTClassification code 10055815Term: Haemorrhage intracerebralSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Ischaemic stroke prevention in patients with atrial fibrillation and previous intracerebral haemorrhage
- Sponsor
- Imperial College of Science, Technology and Medicine
- Enrollment
- 654
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 100
Exclusion Criteria
- •Patient lacks the capacity to consent
- •Fully dependent (modified Rankin scale \>4\)
- •Women who are pregnant, breastfeeding or planning on becoming pregnant
- •Women of childbearing potential (WOCBP 12\.1\) who are unable or unwilling to take measures for effective contraception (4\.8\)
- •ICH occurring within the last 14 days before enrolment
- •ICH occurring longer than 6 months before enrolment
- •ICH resulting from trauma or vascular malformation
- •Indication for long\-term anticoagulation other than AF
- •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 Charasteristics (SmPC). Special warnings and precautions for use for apixaban, dabigatran, edoxaban, rivaroxaban as per SmPC should also be taken into account at randomization.”
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Prevention of Stroke in Survivors of Brain Bleeding with Atrial FibrillatioEUCTR2018-002176-41-ATImperial College of Science, Technology and Medicine654
Active, not recruiting
Phase 1
Prevention of Stroke in Survivors of Brain Bleeding with Atrial FibrillatioEUCTR2018-002176-41-GBImperial College London654
Active, not recruiting
Phase 1
Prevention of Stroke in Survivors of Brain Bleeding with Atrial FibrillatioIschaemic stroke prevention in patients with atrial fibrillation and previous intracerebral haemorrhageTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2018-002176-41-ESImperial College of Science, Technology and Medicine654
Active, not recruiting
Phase 1
Prevention of Stroke in intracerebral haemorrhage survivors with Atrial FibrillatioIschaemic stroke prevention in patients with atrial fibrillation and previous intracerebral haemorrhageMedDRA version: 20.0Level: LLTClassification code 10003661Term: Atrial fibrillation paroxysmalSystem Organ Class: 100000004849MedDRA version: 20.0Level: LLTClassification code 10034039Term: Paroxysmal atrial fibrillationSystem Organ Class: 100000004849MedDRA version: 20.0Level: LLTClassification code 10066551Term: Chronic atrial fibrillationSystem Organ Class: 100000004849MedDRA version: 20.0Level: LLTClassification code 10071668Term: Permanent atrial fibrillationSystem Organ Class: 100000004849MedDRA version: 22.1Level: LLTClassification code 10057613Term: Thromboembolic strokeSystem Organ Class: 100000004852MedDRA version: 21.1Level: LLTClassification code 10022754Term: Intracerebral hemorrhageSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2018-002176-41-DEImperial College of Science Technology and Medicine654
Active, not recruiting
Phase 1
Prevention of Stroke in Survivors of Brain Bleeding with Atrial FibrillatioEUCTR2018-002176-41-ITImperial College of Science, Technology and Medicine654