Condition category
Cancer
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
28/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof AR Green

ORCID ID

Contact details

Department of Haematology
MRC Centre
Hills Road
Cambridge
CB2 2QH
United Kingdom
arg1000@cam.ac.uk

Additional identifiers

EudraCT number

2004-000245-38

ClinicalTrials.gov number

NCT00175838

Protocol/serial number

AA3

Study information

Scientific title

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

South Thames Multi Centre Research Ethics Committee (now called the South East Research Ethics Committee) on 01/08/1997 (MREC ref: 97/1/004)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Leukaemia

Intervention

'Low risk': aspirin only
'Intermediate risk': aspirin/aspirin plus hydroxyurea
'High risk': aspirin plus hydroxyurea/aspirin plus anagrelide

Intervention type

Drug

Phase

Phase III

Drug names

aspirin versus hydroxyurea/aspirin

Primary outcome measures

Vascular occlusion, haemorrhagic events, death, drug side-effects, transformation to acute leukaemia or myelofibrosis

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/1997

Overall trial end date

30/04/2014

Reason abandoned

Eligibility

Participant inclusion criteria

All patients over 18 years of age meeting diagnostic criteria of PT

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

1600

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

United Kingdom

Trial participating centre

Department of Haematology
Cambridge
CB2 2QH
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results (high risk arm) in http://www.ncbi.nlm.nih.gov/pubmed/22709688

Publication citations

  1. Campbell PJ, MacLean C, Beer PA, Buck G, Wheatley K, Kiladjian JJ, Forsyth C, Harrison CN, Green AR, Correlation of blood counts with vascular complications in essential thrombocythemia: analysis of the prospective PT1 cohort., Blood, 2012, 120, 7, 1409-1411, doi: 10.1182/blood-2012-04-424911.

Additional files

Editorial Notes