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MULTICENTRE
STUDIES
PRIMARY THROMBOPROPHYLAXIS OF APL-POSITIVE SUBJECTS
(ALIWAPAS TRIAL)
COORDINATORS
Munther A Khamashta MD
FRCP PhD
Lupus Research Unit, The
Rayne Institute, King’s College London School of Medicine, St Thomas’ Hospital,
London, UK
PROJECT
The
controversy concerning whether or not prophylactic treatment is indicated for
patients with aPL who have no history of thrombosis remains unresolved.
Although low-dose aspirin (75-100mg daily) has been considered to be a logical
first option, the Physician Health Study showed that low-dose aspirin (325mg
daily) in men with aCL did not protect against deep venous thrombosis or
pulmonary embolus. In contrast, hydroxychloroquine may be protective against
the development of thrombosis in aPL-positive patients with SLE.
A
prospective, randomized clinical trial comparing low-dose aspirin alone with
low-dose aspirin plus low-intensity warfarin (INR~1.5) in patients with aPL who
have never had thrombosis is currently under way in the United Kingdom.
Inclusion criteria were 1) aPL positive (Sapporo criteria); 2) SLE patients
without thrombosis but persistently positive aPL; 3) obstetric APS (Sapporo
criteria), without previous history of thrombosis.
Although
1000 patients were originally envisaged to be included in this study, only 233
patients were recruited during a 4-year period. Of them, 167 were randomized by
minimization in order to achieve closely balanced treatment groups and 66
patients were included in the observational arm (these patients did not accept
to be randomized but consented to be followed-up using the same protocol as the
randomized patients).
The Steering Committee and Data Monitoring Committee decided to
stop recruitment (January 2005) and allowed for follow up for at least 5 years.
So far, 15 thrombotic events have occurred. Blood samples from all patients are
being collected every six months at their follow-up visits. Surrogate
laboratory markers are currently being investigated.
For additional
information and applications, please e-mail: munther.khamashta@kcl.ac.uk
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Last updated: 17 November 2005 |
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