Does a new blood thinning drug improve treatment for patients with lupus or thrombotic antiphospholipid syndrome at risk of stroke?

Disease - Antiphospholipid syndrome, systemic lupus erythematosis

Lead applicant - Dr Hannah Cohen

Organisation - University College London Hospital Trust

Type of grant - Clinical Studies

Status of grant - Active

Amount of the original award - £956,860.67

Start date - 2 January 2018

Reference - 21517

Public Summary

What are the aims of this research?

Thrombotic antiphospholipid syndrome is a condition affecting approximately 15% of lupus patients, but may also occur on its own. The condition can cause blood clots (thrombosis) in the arteries of the brain, which can result in strokes. The standard treatment is the blood thinning drug warfarin, which while effective, requires regular blood monitoring and often interacts with certain foods and drugs. The aim of this trial is to determine whether a new blood thinning drug (anticoagulant), called rivaroxaban, is as good or better than the standard treatment, warfarin, at treating patients with lupus/thrombotic antiphospholipid syndrome, who have suffered blood clots in the arteries of the brain causing strokes.

Why is this research important?

This research team have previously shown, through research funded by Versus Arthritis, that a new drug, rivaroxaban, is as good as warfarin at thinning blood in antiphospholipid patients with previous venous blood clots (a clot that occurs in a vein, such as deep vein thrombosis). They now want to investigate whether it has the same effect in thrombotic antiphospholipid syndrome patients, who develop strokes. It is important to treat stroke patients with thrombotic antiphospholipid syndrome effectively with blood thinning treatments to prevent recurrent strokes, which would cause further disability, and can also cause progressive problems with brain function.

To do this, they will randomly give adults with thrombotic antiphospholipid syndrome, with stroke or related brain conditions, either rivaroxaban or warfarin. Patients will have a brain scan at the start of the trial and after 24 months. From these scans, the researchers will examine what is called the ‘white matter hyperintensities’ – small ‘spots’ on the brain which tell us if there is damage to the brain because of blood flow problems – and they will see if these spots have increased or decreased over time. Patients will also have an assessment of brain function and quality of life using a simple questionnaire, and blood tests to assess the blood thinning effect.

How will the findings benefit patients?

This trial could be the first step in establishing whether or not rivaroxaban should be the new standard treatment for patients with thrombotic antiphospholipid syndrome and stroke (or related brain conditions). As mentioned above, rivaroxaban has several advantages over warfarin as it does not interact with food or alcohol and has extremely few drug interactions. It also has a predictable blood thinning effect, so patients do not need monitoring in the way they do for warfarin treatment. Rivaroxaban could improve quality of life in these patients and may also reduce the risk of bleeding and thrombosis.