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ISRCTN
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ISRCTN72251782
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DOI
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10.1186/ISRCTN72251782
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ClinicalTrials.gov identifier
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NCT00175838
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EudraCT number
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2004-000245-38
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Public title
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Randomised study to compare aspirin versus hydroxyurea/aspirin in 'intermediate risk' primary thrombocythaemia (PT) and hydroxyurea/aspirin versus anagrelide/aspirin in 'high risk' primary thrombocythaemia
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Scientific title
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Acronym
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PT1
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Serial number at source
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AA3
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Study hypothesis
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1. In 'low risk' patients: what is the incidence of vascular occlusion while receiving aspirin alone?
2. In 'intermediate risk' patients: does hydroxyurea reduce vascular occlusive events when added to aspirin?
3. In 'high risk' patients: does anagrelide reduce vascular occlusive events as effectively as hydroxyurea?
4. In 'high risk' patients: is anagrelide as effective as hydroxyurea in reducing elevated platelet counts?
5. What is the effect of the treatment modalities on quality of life?
6. Secondary objective In 'intermediate' and 'high risk' patients: does treatment modality alter the risk of leukaemic or myelofibrotic transformation?
Please note as of 08/02/2011 the anticipated end date of this trial has been extended from 31/10/2003 to 31/07/2012 and the participant number has increased from 1200 to 1600.
As of 28/08/2012 the anticipated end date of this trial has been extended from 31/07/2012 to 30/04/2014.
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Lay summary
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http://www.cancerhelp.org.uk/trials/a-trial-looking-at-treatment-for-adults-with-primary-thrombocythaemia
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Ethics approval
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South Thames Multi Centre Research Ethics Committee (now called the South East Research Ethics Committee) on 01/08/1997 (MREC ref: 97/1/004)
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Leukaemia
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Participants - inclusion criteria
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All patients over 18 years of age meeting diagnostic criteria of PT
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Participants - exclusion criteria
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Severe heart disease excludes patients from the 'high risk' study.
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Anticipated start date
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01/07/1997
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Anticipated end date
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30/04/2014
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Status of trial
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Ongoing |
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Patient information material
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Target number of participants
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1600
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Interventions
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'Low risk': aspirin only
'Intermediate risk': aspirin/aspirin plus hydroxyurea
'High risk': aspirin plus hydroxyurea/aspirin plus anagrelide
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Primary outcome measure(s)
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Vascular occlusion, haemorrhagic events, death, drug side-effects, transformation to acute leukaemia or myelofibrosis
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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http://www.haem.cam.ac.uk/primary-thrombocythaemia/
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Publications
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1. 2012 results (high risk arm) in http://www.ncbi.nlm.nih.gov/pubmed/22709688
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Contact name
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Prof
AR
Green
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Address
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Department of Haematology
MRC Centre
Hills Road
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City/town
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Cambridge
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Zip/Postcode
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CB2 2QH
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Country
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United Kingdom
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Email
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arg1000@cam.ac.uk
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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25/10/2000
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Last edited
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28/08/2012
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Date ISRCTN assigned
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25/10/2000
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