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
| ISRCTN | ISRCTN72251782 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72251782 |
| EudraCT/CTIS number | 2004-000245-38 |
| ClinicalTrials.gov number | NCT00175838 |
| Secondary identifying numbers | AA3 |
- Submission date
- 25/10/2000
- Registration date
- 25/10/2000
- Last edited
- 28/08/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Contact information
Prof AR Green
Scientific
Scientific
Department of Haematology
MRC Centre
Hills Road
Cambridge
CB2 2QH
United Kingdom
| arg1000@cam.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | PT1 |
| Study hypothesis | 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. |
| Ethics approval(s) | South Thames Multi Centre Research Ethics Committee (now called the South East Research Ethics Committee) on 01/08/1997 (MREC ref: 97/1/004) |
| Condition | Leukaemia |
| Intervention | 'Low risk': aspirin only 'Intermediate risk': aspirin/aspirin plus hydroxyurea 'High risk': aspirin plus hydroxyurea/aspirin plus anagrelide |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | aspirin versus hydroxyurea/aspirin |
| Primary outcome measure | Vascular occlusion, haemorrhagic events, death, drug side-effects, transformation to acute leukaemia or myelofibrosis |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/07/1997 |
| Overall study end date | 30/04/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 1600 |
| Participant inclusion criteria | All patients over 18 years of age meeting diagnostic criteria of PT |
| Participant exclusion criteria | Severe heart disease excludes patients from the 'high risk' study. |
| Recruitment start date | 01/07/1997 |
| Recruitment end date | 30/04/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Haematology
Cambridge
CB2 2QH
United Kingdom
CB2 2QH
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results (high risk arm) | 16/08/2012 | Yes | No |
