Start or STop Anticoagulants Randomised Trial (SoSTART)

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.

Conditions

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

Interventions

DRUG

Apixaban

The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.

DRUG

Rivaroxaban

The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.

DRUG

Edoxaban

The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.

DRUG

Dabigatran

The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.

DRUG

Acenocoumarol

The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.

DRUG

Phenindione

The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.

DRUG

Warfarin

The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.

Sponsors & Collaborators

• NHS Lothian

  collaborator OTHER_GOV

• University of Edinburgh

  lead OTHER

Principal Investigators

• Rustam Al-Shahi Salman, MA PhD FRCP · University of Edinburgh

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-03-28

Primary Completion

2021-03-26

Completion

2021-03-26

Countries

• United Kingdom

Study Locations