Can you help with a research trial based in London?

The Rivaroxaban in APS (RAPS) trial is now recruting new patients to the trial. Our charity has agreed to help with this important trial as it could finally provide a safe alternative treatment to warfarin.

Below is the recruitment paper from Professor Hannah Cohen of University College Hospital in London but, to put simply, they have a very strict criteria where the patient:

- has a positive diagnosis of APS

- is based in the UK

- has only had a DVT and/or PE, but not a stroke or TIA related to APS

- has a target INR range of between 2.0–3.0

- has been taking warfarin for at least three months

If you meet the criteria and can travel to one of the London centres (either UCL or the Haematology Department at St Thomas') then please do get in touch. There will be six visits in seven months and your travel expenses will be paid for.

Thanks in advance to anyone who is able to participate,

Kate - kate.hindle@hughes-syndrome.org

RAPS (Rivaroxaban in AntiPhospholipid Syndrome)

A prospective randomised controlled phase II/III clinical trial of rivaroxaban versus warfarin in patients with thrombotic antiphospholipid syndrome, with or without SLE

Background and study aims

In patients with antiphospholipid syndrome (APS), with or without ‘lupus’, long-term anticoagulation with warfarin is the established treatment following deep vein thrombosis (DVT) and/or pulmonary embolism (PE) to prevent further thrombosis, which can be life-threatening.

Rivaroxaban is a recently introduced oral anticoagulant (blood thinner), which is given as fixed-dose tablets once daily. Unlike warfarin, rivaroxaban does not require routine INR monitoring blood tests because it has a predictable anticoagulant effect, similar to heparin injections. Also, unlike warfarin, rivaroxaban does not interact with food or alcohol and has few drug interactions. It is unlikely that antiphospholipid antibodies will interfere with rivaroxaban's effects on blood clotting (as is the case with warfarin) as, unlike warfarin, it has a very targeted effect on blood.

We are comparing the anticoagulant (blood thinning) effect of rivaroxaban with that of warfarin in patients with thrombotic APS, with or without ‘lupus’. We are doing this by assessment of a specialised and excellent measure of anticoagulation called the 'thrombin generation test' (TGT). We are also assessing rates of bleeding and further thrombosis, and comparing serious adverse events and quality of life in patients on rivaroxaban with those on warfarin. If we can demonstrate that the anticoagulant effect of rivaroxaban is not inferior to that of warfarin, and that there is no increase in the rate of serious adverse effects (very unlikely – see below), we believe that this would provide good evidence to change practice for our patients, and make rivaroxaban the standard of care for patients with thrombotic APS, with or without ‘lupus’.

Who can participate?

Patients with thrombotic APS, with or without lupus, who have had a DVT and/or PE (but not a TIA (transient ischaemic attack) or stroke related to APS), and have been on warfarin at a target INR of 2.5 (range 2.0–3.0) for at least three months are eligible to take part in the study.

Some patients being run at a target INR of 2.0-3.0 and who have had more than one DVT and/or PE may also be eligible if the event occurred whilst off anticoagulation or when there was inadequate anticoagulation.

The trial results will not be applicable to patients who require a higher target INR range than 2.0-3.0. This is because there are no studies to compare warfarin versus rivaroxaban in patients being run at a higher target INR and therefore, future studies are needed to see whether rivaroxaban would be effective for such patients.

What does the study involve?

Patients are randomly allocated to either remain on warfarin or to switch to rivaroxaban. The trial involves six visits over a seven month period. Trial visits will enable face-to-face contact with healthcare professionals to discuss any concerns and patients will be able to contact the Research Nurse to discuss any problems between visits. Two extra blood samples (each about four teaspoonfuls) will be taken prior to random allocation and six weeks later, in addition to routine blood tests. The trial treatment will last for six months and following this, patients will be offered appropriate anticoagulation.

What are the possible benefits and risks of participating?

Rivaroxaban is licensed in the UK and approved by NICE for the prevention of DVT/PE in patients undergoing hip and knee replacements and also for the treatment of DVT and prevention of recurrent DVT and PE following an acute DVT; and the prevention of stroke in patients with atrial fibrillation (an abnormal heart rhythm associated with an increased risk of stroke). Studies on tens of thousands of patients with DVT/PE or other conditions have shown that rivaroxaban is effective with a similar safety profile to warfarin. Indeed, to date in studies on a total of over 65,000 patients no major safety issues have emerged. It is likely that some patients with APS were included in the studies on DVT/PE, but there is no separate information available on this group.

Where is the study run from?

The study is taking place at University College London Hospitals NHS Foundation Trust and Guys and St Thomas’ NHS Foundation Trust (UK).

Funders

Arthritis Research UK and a drug company (http://www.controlled-trials.com/ISRCTN68222801)

If you are interested in participating in this trial, please contact either:

Dr Hannah Cohen

Department of Haematology UCL Division of Medicine

1st Floor Central, 250 Euston Road

London NW1 2PG

email: hannah.cohen@uclh.nhs.uk

Professor Beverley Hunt

Department of Haematology

Guy’s and St Thomas’ NHS Foundation Trust

London SE1 7EG

email: beverley.hunt@gstt.nhs.uk

11 Replies

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  • Thanks for this unfortunately I'm a target range 3-4.

  • Thanks anyway TJ - we've had a good response on Facebook and I have yet to contact our supporting members, so hopefully we will be able to recruit enough. Kx

  • I take rivaroxabin could I help as I met most of the criteria can u give me some details please

  • Hi Rach - as you are taking rivaroxaban already, you don't meet the criteria. However, it's really good to hear that you seem to be getting on ok with the new drug. Could I ask who prescribed it to you? I know the specialists at the Royal Gwent are really on the ball - are you under the care of them? Kx

  • hi kate I was seen at the gwent hun by some consultants but changed to someone who diagnosed my aps and knows more .... her name is dr sarah lewis who works btween Neville hall and royal gwent...... I c her every year and have seen dr chris Jenkins 2 who 8is very good... hope this helps.

    yea I do seem 2 getting on well which gd and due 2 c dr lewis in april....

    sorry couldn't help

  • Yes, I know Dr Jenkins as he treated my Dad before he died - amazing doctor and very pro Hughes/APS. He also recommended Sarah Lewis to put on our directory so I'm glad we've listed them both - if you ever come across anyone else who you would recommend, please don't forget to let me know. Kx

  • Hi Kate I so wanted to be part of this trial I was due to start Rivaoxaban in Oct/Nov when I went back to Guys to get started I was told that I couldn't take it as the manufacturer wouldn't guarantee that I could absorb it following a gastric bypass last year if they change their mind I am available

  • Hi Alison - please do contact Hannah Cohen as she would be best placed to know about whether the gastric bypass would still make a difference. It would be a shame if you couldn't take part when you wanted to.

  • Hi Kate,

    I am on the Rivaroxaban trial since late Nov.....I am getting along fine with it and after being on Warfarin since jan 2008 and self-testing....I find it liberating.....no more blood testing and upping and downing dosage and avoiding greens etc....one dose daily....

    I have written to my GP to request they continue prescribing it for me when I finish trials late May.....

  • Hi Kate,

    I think I meet all the criteria and I emailed Hannah about the trial who gave me some advice. However, unfortunately my haemotologist refused to acknowledge my requests for a referral letter to the trial. I am due to see a specilaist on June 3rd and intend to discuss the trial again with him. I think its really important to help out if possible, especially since I have personally felt so ill since starting warfarin 18 months ago. I'll keep you posted. x

  • Thanks Krysty - it would be really helpful if you could take part in the trial as recruitment is slow but steady, however, if the full amount of patients is not met, the trial could be abandoned. Good luck next month and do keep me and Hannah Cohen posted of any news xx

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