Avoid Anticoagulation After IntraCerebral Haemorrhage

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Lille

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

18 Jan 2019 → ongoing

Decision date (initial)

2024-10-24

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

PHRC-2016

External identifiers

EU CT number

2024-514094-22-00

EudraCT number

2017-004371-31

ClinicalTrials.gov

NCT03243175

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

To assess the efficacy of the strategy "Direct OAC" or "avoiding OAC with LAAC" compared to "usual care (avoiding anticoagulation and LAAC)" on individual component of the net clinical benefit, mortality, dependency and health-related quality

Secondary objectives 3

1. To identify MRI cerebral biomarkers (such as brain microbleeds and superficial siderosis) that may predict the risk of future intracranial haemorrhages
2. To describe complications related to the endovascular procedure
3. To describe the overall success of the procedure

Conditions and MedDRA coding

Intrecerebral Haemorrhage

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Adult (older than 18 years old, no upper age limit)
2. With a history of paroxysmal, persistent or long-standin g non-valvular atrial fibrillation (documented on an electrocardiogram)
3. And a CHA2DS2VASc (22) score of 2 or more who have an indication for long-term anticoagulation
4. Who suffered from a spontaneous intracerebral haemorrhage (while being treated with oral anticoagulants or not) documented with brain CT or MRI
5. More than 1 month (more precisely 30 days) before randomization (no upper delay limit)
6. For whom there is a clinical equipoise regarding the choice of the best preventive strategy to avoid future vascular events.
7. Being affiliated to the Sécurité Sociale

Exclusion criteria 16

1. Severe chronic renal insufficiency (clearance of creatinine < 15ml/min)
2. Pre-randomisation modified Rankin (2) score of 4 or 5
3. Conditions other than atrial fibrillation for which the patient requires long term anticoagulation (for example prosthetic mechanical heart valve)
4. Serious bleeding events within the 6 months before randomisation (except for intracerebral haemorrhage)
5. Life expectancy of less than 1 year
6. Pregnancy or breastfeeding
7. Woman of childbearing age not taking effective contraception
8. People under guardianship, trusteeship, deprive of freedom
9. Any other contraindication according to the health care team
10. (Exclusion criteria related to the LAAC only): Contraindications due to local, anatomical reasons (such as thrombus in the left atrial appendage, infection with a risk of endocarditis)
11. (Exclusion criteria related to the LAAC only): Patients older than 85 years
12. (Exclusion criteria related to the LAAC only): CHA2DS2VASc score of 2 or 3
13. (Exclusion criteria related to the LAAC only): Any other contraindication according to the health care team
14. (Exclusion criteria related to the Direct OAC only): Allergy to apixaban
15. (Exclusion criteria related to the Direct OAC only): Coexisting conditions predisposing to head trauma (e.g. gait disturbances, uncontrolled seizures disorders)
16. (Exclusion criteria related to the Direct OAC only): Any other contraindication according to the health care team

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is a composite criterion including all fatal or lifethreatening and major vascular events, i.e. cardiovascular/cerebrovascular ischaemic or haemorrhagic intracranial/extracranial events within 24 months after randomization

Secondary endpoints 7

1. Each individual component of the composite outcome at 24 month after randomization (fatal or non-fatal major vascular events, i.e. cardiovascular/cerebrovascular ischaemic or haemorrhagic intracranial/extracranial events)
2. Death of any cause at 24 months after randomization
3. Functional dependence scored on the modified Rankin Scale at 24 months after randomization in a shift analysis
4. Health-related quality of life measured by the EQ-5D (EuroQoL) at 24 months after randomization
5. Baseline small-vessel diseases biomarkers on brain MRI (brain microbleeds, leukoaraiosis, superficial siderosis, perivascular spaces, territorial infarcts, silent macrohaemorrhages, cortical atrophy)
6. Complications of endovascular treatment (up to 30 days)
7. Overall evaluation of the success of the procedure (at 30 days)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Lille

Sponsor organisation

Centre Hospitalier Universitaire De Lille

Address

2 Avenue Oscar Lambret, Cs 70001 Cs 70001

City

Lille Cedex

Postcode

59037

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Lille

Contact name

Prof. Charlotte CORDONNIER

Public contact point

Organisation

Centre Hospitalier Universitaire De Lille

Contact name

Mme Brigitte COURTOIS

Locations

1 EU/EEA country · 36 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications