Brief Summary

Primary research question: For adults surviving spontaneous (non-traumatic) symptomatic intracranial haemorrhage with persistent/paroxysmal atrial fibrillation/flutter (AF), does starting full treatment dose oral anticoagulation (OAC) result in a beneficial net reduction of all serious vascular events compared with not starting OAC? Trial design: Investigator-led, multicentre, randomised, open, assessor-masked, parallel group, clinical trial of investigational medicinal product (CTIMP) prescribing strategies. Investigators plan for a pilot phase, followed by a safety phase.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

203

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Mar 2018

Typical duration for phase_3

Geographic Reach

1 country

67 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3 years study duration

First Submitted

Initial submission to the registry

May 10, 2017

Completed

5 days until next milestone

First Posted

Study publicly available on registry

May 15, 2017

Completed

11 months until next milestone

Study Start

First participant enrolled

March 28, 2018

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2021

Completed

Last Updated

April 8, 2022

Status Verified

May 1, 2021

Enrollment Period

3 years

First QC Date

May 10, 2017

Last Update Submit

March 31, 2022

Conditions

Intracranial Hemorrhages Intracranial Hemorrhage, Hypertensive Subarachnoid Hemorrhage Subdural Hematoma Intraventricular Hemorrhage Atrial Fibrillation Atrial Flutter Small Vessel Cerebrovascular Disease Microhaemorrhage

Keywords

Oral anticoagulantFactor Xa inhibitorsDirect thrombin inhibitorVitamin K antagonistAntiplatelet drug

Outcome Measures

Primary Outcomes (2)

The number of participants recruited per site per month (in the pilot phase of the trial)
The rate of recruiting up to 60 participants to determine the feasibility of recruiting the target sample size in the main phase of the trial in an acceptable timescale.
1 year after trial initiation
Recurrent symptomatic spontaneous intracranial haemorrhage (in the safety phase of the trial)
\~60 hospital sites will recruit at least 190 participants to determine whether the risk of recurrent symptomatic intracranial haemorrhage is sufficiently low (non-inferior) to justify a definitive trial.
1 year after randomisation

Secondary Outcomes (1)

The proportions of all eligible patients recorded on screening logs who are recruited, unsuitable, or decline to participate (in the pilot phase of the trial)
1 year after randomisation

Other Outcomes (4)

The number of Symptomatic serious vascular events: (in the safety phase of the trial)
1 year after randomisation
The number of Individual symptomatic vascular events: (in the safety phase of the trial)
1 year after randomisation
Annual ratings of participant dependence completed by participant, their carer or nominated contact, or healthcare provider (e.g. general practitioner):
1 year after randomisation
+1 more other outcomes

Study Arms (2)

Start oral anticoagulant (OAC)

EXPERIMENTAL

If the patient is randomized in this arm, an oral anticoagulant: * Factor Xa inhibitors: Apixaban or Rivaroxaban or Edoxaban or * Direct thrombin inhibitor: Dabigatran or * Vitamin K antagonists: Acenocoumarol or Phenindione or Warfarin chosen by the patient's physician before the randomisation, will be prescribed long-term (≥1 year) to the patient.

Drug: ApixabanDrug: RivaroxabanDrug: EdoxabanDrug: DabigatranDrug: AcenocoumarolDrug: PhenindioneDrug: Warfarin

Do not start oral anticoagulant (OAC)

NO INTERVENTION

If the patient is randomized in this arm, anticoagulant drugs will not be prescribed to the patient during the entire study period. The standard clinical practice without OAC may include: * antiplatelet drug(s) or * no antithrombotic drugs.