Lead Investigator: Rustam Al-Shahi Salman, University of Edinburgh
Title of Proposal Research: Collaboration Of Controlled Randomised trials of Oral Antithrombotic agents after intraCranial Haemorrhage (COCROACH)
Vivli Data Request: 7581
Funding Source: The COCROACH team are employed by the University of Edinburgh, which received a grant from a charity (the British Heart Foundation) to pay for the statistician’s time on the project.
Potential Conflicts of Interest: Professor Rustam Al-Shahi Salman) coordinates the Collaboration Of Controlled Randomised trials of Oral Antithrombotic agents after intraCranial Haemorrhage (COCROACH; https://www.ed.ac.uk/clinical-brain-sciences/research/so-start/for-collaborators) and is the senior author of the Cochrane Systematic Review of antithrombotic drugs after stroke due to intracerebral haemorrhage (https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD012144 .pub2/full/ta#) There are no financial or other competing interests with this application.
Summary of the Proposed Research:
Stroke due to bleeding in the brain, known as brain haemorrhage, affects at least 3 million people in the world each year. People who survive brain haemorrhage are at risk of suffering another “major vascular event”. These major vascular events include heart attacks, strokes, and death due to clotting or bleeding problems. The risk of having a major vascular event is up about 8% each year after brain haemorrhage. Randomised controlled trials found that people with an iregular heart beat, known as atrial fibrillation (or AF for short) benefit from blood-thinning anticoagulant drugs.
Why are we doing this research?
Doctors aren’t sure whether anticoagulant drugs can be used for people with AF who have had a brain haemorrhage. A few, small randomised controlled trials of anticoagulant drugs have been done in patients with brain haemorrhage and AF. These include our SoSTART trial (203 patients), the APACHE-AF trial (101 patients), and the NASPAF-ICH trial (30 patients). However, these trials were small and none reached a conclusive result.
What will we do?
We will perform two different types of analysis by combining data from all completed randomised controlled trials of oral anticoagulation for AF after brain haemorrhage to get the most precise and reliable answer. As well as the three trials mentioned above, we want to include data from 80 patients with brain haemorrhage and AF, who were randomised between Edoxaban and placebo in the ELDERCARE-AF trial. That’s why we are requesting data via Vivli from the ELDERCARE-AF trial.
What will this research mean?
These analyses will provide the most precise and reliable information about the effect of oral anticoagulation for AF after brain haemorrhage, which will inform the care of patients with this problem. We will publish the results in the Cochrane Library and in a peer-reviewed journal.
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study of DU-176b in Patients With NVAF Aged 80 Years or Older Who Are Ineligible for Available Oral Anticoagulation Therapy
Data Contributor: Daiichi Sankyo, Inc
Study ID: NCT02801669
Sponsor ID: DU176b-C-J316