Start or STop Anticoagulants Randomised Trial (SoSTART)

Sponsor

University of Edinburgh (Other)

Overall Status

Completed

CT.gov ID

NCT03153150

Collaborator

NHS Lothian (Other)

203

Enrollment

Locations

Arms

35.9

Actual Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intracranial Hemorrhages Intracranial Hemorrhage, Hypertensive Subarachnoid Hemorrhage Subdural Hematoma Intraventricular Hemorrhage Atrial Fibrillation Atrial Flutter Small Vessel Cerebrovascular Disease Microhaemorrhage	Drug: Apixaban Drug: Rivaroxaban Drug: Edoxaban Drug: Dabigatran Drug: Acenocoumarol Drug: Phenindione Drug: Warfarin	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

203 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

1:1 allocation of intervention: comparator, using a minimisation algorithm1:1 allocation of intervention: comparator, using a minimisation algorithm

Masking:

Single (Outcomes Assessor)

Masking Description:

PROBE design

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 28, 2018

Actual Primary Completion Date :

Mar 26, 2021

Actual Study Completion Date :

Mar 26, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Start oral anticoagulant (OAC) 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: Apixaban The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation. Other Names: Eliquis Drug: Rivaroxaban The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation. Other Names: Xarelto Drug: Edoxaban The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation. Other Names: Lixiana Drug: Dabigatran The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation. Other Names: Pradaxa Drug: Acenocoumarol The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation. Other Names: Sinthrome Drug: Phenindione The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation. Other Names: Dindevan Drug: Warfarin The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation. Other Names: Marevan Coumadin
No Intervention: Do not start oral anticoagulant (OAC) 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.

Arm

Intervention/Treatment

Experimental: Start oral anticoagulant (OAC)

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: Apixaban