EUCTR2018-002176-41-GB
Active, not recruiting
Phase 1
PREvention of STroke in Intracerebral haemorrhaGE survivors with Atrial Fibrillation (PRESTIGE-AF) - PRESTIGE-AF
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Imperial College London
- Enrollment
- 654
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
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: 0
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 100
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:
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 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 FibrillatioIschaemic 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]EUCTR2018-002176-41-FRImperial 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