Clinical Trial: Start or STop Anticoagulants Randomised Trial (SoSTART)

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Start or STop Anticoagulants Randomised Trial (SoSTART) After Spontaneous Intracranial Haemorrhage

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 main phase.


Detailed Summary:

Bleeding within the skull, also known as brain haemorrhage, affects 3 million people in the world each year.

One in five people who survive brain haemorrhage have an irregular heart rhythm called 'atrial fibrillation', which puts them at risk of stroke and other blood clots.

Blood-thinning medicines, known as 'anticoagulant' drugs, are used in everyday clinical practice to protect people with atrial fibrillation from developing blood clots. However, these drugs also increase the risk of bleeding and are usually stopped when the brain haemorrhage occurs.

But when patients recover from brain haemorrhage, they and their doctors are often uncertain about whether to start or stop these drugs to prevent further clots occurring, or whether to avoid them in case they increase the risk of brain haemorrhage happening again.

Investigators want to find out whether starting or not starting an anticoagulant drugs is better for those patients.

A network of hospital doctors, nurses, and other staff will identify people who survive brain haemorrhage and have atrial fibrillation. If a patient and their doctor are uncertain about whether to start an anticoagulant drug, they may invite the patient to participate.

In the pilot phase, investigators aim to recruit at least 60 participants to determine the feasibility of recruiting the target sample size of at least 800 participants in the main phase of the trial.

Investigators will follow-up all participants for at least one year to determine whether prescribing an anticoagulant drug reduces the occurrence of all serious vascular events like heart at
Sponsor: University of Edinburgh

Current Primary Outcome:

  • The number of participants recruited per site per month (in the pilot phase of the trial) [ Time Frame: 1 year after trial initiation ]
    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.
  • The incidence rate of the first occurrence of the composite outcome of all symptomatic serious vascular events (in the main phase of the trial) [ Time Frame: 1 year after randomisation ]

    The composite outcome will comprise:

    • Non-fatal acute coronary syndrome (i.e. not followed by death within 30 days of onset)
    • Non-fatal stroke (i.e. ischaemic, haemorrhagic or unknown sub-type, not followed by death within 30 days of onset)
    • Death from a vascular cause (i.e. haemorrhagic or ischaemic events followed by death within 30 days), sudden death, or death of an unknown cause.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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) [ Time Frame: 1 year after randomisation ]
    The acceptability of the trial protocol to investigators and patients.
  • The incidence rate of the first occurrence of each individual symptomatic serious vascular event type (in the main phase of the trial) [ Time Frame: 1 year after randomisation ]

    Major haemorrhagic events:

    • Fatal bleeding, and/or
    • Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or
    • Bleeding causing a fall in haemoglobin level of 20 g/l (1.24 mmol/l) or more, or leading to transfusion of two or more units of whole blood or red cells

    Symptomatic ischaemic events:

    • transient ischaemic attack
    • ischaemic stroke
    • acute coronary syndrome
    • peripheral arterial occlusion/insufficiency
    • mesenteric ischaemia
    • retinal arterial occlusion
    • deep vein thrombosis
    • pulmonary embolism
    • cardiac death with symptoms suggestive of myocardial ischaemia (type 3), or evidence of arrhythmia

    Revascularisation procedures (carotid, coronary, or peripheral arterial)

    Symptomatic stroke of uncertain sub-type

    Individual types of fatal events

  • The proportion of participants in each category of death or dependence on the modified Rankin Scale (in the main phase of the trial) [ Time Frame: 1 year after randomisation ]
    modified Rankin Scale score, collected using structured questions, completed by the participant, their carer or a nominated contact


Original Secondary Outcome: Same as current

Information By: University of Edinburgh

Dates:
Date Received: May 10, 2017
Date Started: July 3, 2017
Date Completion: July 1, 2023
Last Updated: May 12, 2017
Last Verified: May 2017