Start or STop Anticoagulants Randomised Trial (SoSTART) — SoSTART  

Atrial Fibrillation Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

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 190 participants in the safety 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 attack, stroke compared with a policy of avoiding oral anticoagulant. ;

Related Conditions & MeSH terms

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

• NCT number: NCT03153150
• Study type: Interventional
• Source: University of Edinburgh
• Status: Completed
• Phase: Phase 3
• Start date: March 28, 2018
• Completion date: March 26, 2021