Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000004662
Ethics application status
Approved
Date submitted
12/07/2005
Date registered
12/07/2005
Date last updated
27/05/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
ASPIRE
Scientific title
A multi-centre, randomised, double-blind, placebo-controlled clinical trial examining the efficacy and safety of low-dose aspirin after initial anticoagulation to prevent recurrent venous thromboembolism
Secondary ID [1] 262166 0
CTRI/2007/091/000029
Secondary ID [2] 280367 0
ACTRN12611000684921 - INSPIRE is a prospective combined analysis of the ASPIRE and WARFASA studies
Universal Trial Number (UTN)
Trial acronym
ASPIRE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous thromboembolism 66 0
Condition category
Condition code
Cardiovascular 78 78 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The ASPIRE study is an international multicentre, randomised, double-blind placebo controlled clinical trial designed to examine the efficacy and safety of low dose aspirin (100mg daily) to prevent recurrent deep venous thrombosis (DVT) or pulmonary embolism (PE) in patients with a first episide of unprovoked VTE who have completed initial treatment with heparin and warfarin.
Intervention code [1] 16 0
Prevention
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 110 0
The primary outcome is the composite of objectively diagnosed symptomatic VTE or fatal PE
Timepoint [1] 110 0
At the end of the study
Secondary outcome [1] 247 0
A) The composite of symptomatic VTE, myocardial infarction, stroke, or cardiovascular death (all serious thrombotic vascual events).
Timepoint [1] 247 0
At the end of the study
Secondary outcome [2] 248 0
B) Symptomatic VTE , myocardial infarction, stroke, all cause mortality and major bleeding (a measure of net clinical benefit).
Timepoint [2] 248 0
At the end of the study

Eligibility
Key inclusion criteria
First episode of unprovoked DVT or PE-completion of initial treatment with unfractionated heparin or low-molecular-weight heparin (or effective alternative) and warfarin (recommended treatment duration 6-24 months)
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy, intolerance or contraindication for aspirin-Clear indication for aspirin, clopidogrel or a conventional (COX 1/2) NSAID.-Indication for long-term anticoagulant therapy (eg prosthetic heart valve)-Life expectancy of less than 12 months-active bleeding or at high risk of bleeding-anticipated non-adherance to study medications-inability to attend follow-up because of geographical inaccessibility

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation is via a secure web based allocation system
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation concealment is maintained via a central web based allocation sytem using a computer programme. Randomisation is stratified by centre and duration of anticoagulant treatment (<26 weeks and > 26 weeks)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2003
Actual
9/05/2003
Date of last participant enrolment
Anticipated
Actual
11/08/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
822
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 102 0
India
State/province [1] 102 0
Country [2] 103 0
New Zealand
State/province [2] 103 0
Country [3] 104 0
Singapore
State/province [3] 104 0
Country [4] 105 0
Argentina
State/province [4] 105 0

Funding & Sponsors
Funding source category [1] 108 0
Government body
Name [1] 108 0
National Health & Medical Research Council
Country [1] 108 0
Australia
Funding source category [2] 109 0
Charities/Societies/Foundations
Name [2] 109 0
New Zealand Health Research Committee
Country [2] 109 0
New Zealand
Funding source category [3] 110 0
Government body
Name [3] 110 0
NSW Health
Country [3] 110 0
Australia
Funding source category [4] 111 0
Charities/Societies/Foundations
Name [4] 111 0
The Australasian Society of Thrombosis and Haemostasis
Country [4] 111 0
Australia
Funding source category [5] 112 0
Commercial sector/Industry
Name [5] 112 0
Bayer (study drug)
Country [5] 112 0
Germany
Primary sponsor type
University
Name
NHMRC Clinical Trials Centre, University of Sydney
Address
Locked Bag 77. Camperdown. NSW 1450. Australia
Country
Australia
Secondary sponsor category [1] 83 0
None
Name [1] 83 0
None
Address [1] 83 0
Country [1] 83 0
Other collaborator category [1] 251990 0
University
Name [1] 251990 0
St John's Medical College
Address [1] 251990 0
Division of Clinical Trials
Institute of Population Health and Clinical Research
St. John?s National Academy of Health Sciences
Koramangala, Bangalore 560 034
India
Country [1] 251990 0
India
Other collaborator category [2] 251991 0
Commercial sector/Industry
Name [2] 251991 0
Estudios Cl?nicos Latinoam?rica
Address [2] 251991 0
Madres de Plaza 25 de Mayo 3020, piso 10
Torres Nordlink
2000 ? Rosario
Argentina
Country [2] 251991 0
Argentina

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 819 0
Box Hill Hospital
Ethics committee address [1] 819 0
Ethics committee country [1] 819 0
Australia
Date submitted for ethics approval [1] 819 0
Approval date [1] 819 0
Ethics approval number [1] 819 0
Ethics committee name [2] 820 0
Canberra Hospital
Ethics committee address [2] 820 0
Ethics committee country [2] 820 0
Australia
Date submitted for ethics approval [2] 820 0
Approval date [2] 820 0
Ethics approval number [2] 820 0
Ethics committee name [3] 821 0
Concord Hospital
Ethics committee address [3] 821 0
Ethics committee country [3] 821 0
Australia
Date submitted for ethics approval [3] 821 0
Approval date [3] 821 0
Ethics approval number [3] 821 0
Ethics committee name [4] 822 0
Flinders Medical Centre
Ethics committee address [4] 822 0
Ethics committee country [4] 822 0
Australia
Date submitted for ethics approval [4] 822 0
Approval date [4] 822 0
Ethics approval number [4] 822 0
Ethics committee name [5] 823 0
Geelong Hospital
Ethics committee address [5] 823 0
Ethics committee country [5] 823 0
Australia
Date submitted for ethics approval [5] 823 0
Approval date [5] 823 0
Ethics approval number [5] 823 0
Ethics committee name [6] 824 0
Gosford Hospital
Ethics committee address [6] 824 0
Ethics committee country [6] 824 0
Australia
Date submitted for ethics approval [6] 824 0
Approval date [6] 824 0
Ethics approval number [6] 824 0
Ethics committee name [7] 825 0
Mater Misercordiae Hospital
Ethics committee address [7] 825 0
Ethics committee country [7] 825 0
Australia
Date submitted for ethics approval [7] 825 0
Approval date [7] 825 0
Ethics approval number [7] 825 0
Ethics committee name [8] 826 0
Monash Medical Centre
Ethics committee address [8] 826 0
Ethics committee country [8] 826 0
Australia
Date submitted for ethics approval [8] 826 0
Approval date [8] 826 0
Ethics approval number [8] 826 0
Ethics committee name [9] 827 0
Prince of Wales Hospital
Ethics committee address [9] 827 0
Ethics committee country [9] 827 0
Australia
Date submitted for ethics approval [9] 827 0
Approval date [9] 827 0
Ethics approval number [9] 827 0
Ethics committee name [10] 828 0
Princess Alexandra Hoapital
Ethics committee address [10] 828 0
Ethics committee country [10] 828 0
Australia
Date submitted for ethics approval [10] 828 0
Approval date [10] 828 0
Ethics approval number [10] 828 0
Ethics committee name [11] 829 0
Queen Elizabeth Hospital
Ethics committee address [11] 829 0
Ethics committee country [11] 829 0
Australia
Date submitted for ethics approval [11] 829 0
Approval date [11] 829 0
Ethics approval number [11] 829 0
Ethics committee name [12] 830 0
Redcliffe Hospital
Ethics committee address [12] 830 0
Ethics committee country [12] 830 0
Australia
Date submitted for ethics approval [12] 830 0
Approval date [12] 830 0
Ethics approval number [12] 830 0
Ethics committee name [13] 831 0
Royal Brisbane & Women's Hospital
Ethics committee address [13] 831 0
Ethics committee country [13] 831 0
Australia
Date submitted for ethics approval [13] 831 0
Approval date [13] 831 0
Ethics approval number [13] 831 0
Ethics committee name [14] 832 0
Royal Hobart Hospital
Ethics committee address [14] 832 0
Ethics committee country [14] 832 0
Australia
Date submitted for ethics approval [14] 832 0
Approval date [14] 832 0
Ethics approval number [14] 832 0
Ethics committee name [15] 833 0
Royal North Shore Hospital
Ethics committee address [15] 833 0
Ethics committee country [15] 833 0
Australia
Date submitted for ethics approval [15] 833 0
Approval date [15] 833 0
Ethics approval number [15] 833 0
Ethics committee name [16] 834 0
Royal Perth Hospital
Ethics committee address [16] 834 0
Ethics committee country [16] 834 0
Australia
Date submitted for ethics approval [16] 834 0
Approval date [16] 834 0
Ethics approval number [16] 834 0
Ethics committee name [17] 835 0
St George Hospital
Ethics committee address [17] 835 0
Ethics committee country [17] 835 0
Australia
Date submitted for ethics approval [17] 835 0
Approval date [17] 835 0
Ethics approval number [17] 835 0
Ethics committee name [18] 836 0
St Vincent's Hospital Melbourne
Ethics committee address [18] 836 0
Ethics committee country [18] 836 0
Australia
Date submitted for ethics approval [18] 836 0
Approval date [18] 836 0
Ethics approval number [18] 836 0
Ethics committee name [19] 837 0
St Vincent's Hospital, Sydney
Ethics committee address [19] 837 0
Ethics committee country [19] 837 0
Australia
Date submitted for ethics approval [19] 837 0
Approval date [19] 837 0
Ethics approval number [19] 837 0
Ethics committee name [20] 838 0
The Alfred Hospital
Ethics committee address [20] 838 0
Ethics committee country [20] 838 0
Australia
Date submitted for ethics approval [20] 838 0
Approval date [20] 838 0
Ethics approval number [20] 838 0

Summary
Brief summary
The ASPIRE is looking at the effectiveness and safety of giving low-dose aspirin to prevent recurrent deep vein thrombosis (DVT) or pulmonary embolism (PE) in patients with a first episode of unprovoked venous thromboembolism (VTE) who have completed initial anticoagulant treatment with heparin and warfarin.
Recruitment has now closed, with 822 patients enrolled from centres in Australia, New Zealand, Singapore, India and Argentina.
The ASPIRE study addresses a question of major clinical and public health importance with several million patients at risk of recurrent VTE worldwide. If aspirin is found to be beneficial, this safe, inexpensive, and practicable intervention could be very widely applied and prevent thousands of patients from experiencing recurrent venous thromboembolism each year.
In Australia alone, a 30% reduction in risk of recurrent VTE could conservatively be expected to prevent 375 to 525 cases of venous thrombosis and save 56-80 lives in the first year.
Trial website
Trial related presentations / publications
Published in New England Journal of Medicine 2012. Also Late Breaking Clinical Trial at American Heart Association meeting in November 2012.
Reference: Brighton TA, Eikelboom JW, Mann K, Mister R, Gallus A, Ockelford P, Gibbs H, Hague W, Xavier D, Diaz R, Kirby A, Simes J; ASPIRE Investigators. Low-dose aspirin for preventing recurrent venous thromboembolism. New England Journal of Medicine 2012; 367(21): 1979–1987.
Public notes

Contacts
Principal investigator
Name 35152 0
Dr Timothy Brighton
Address 35152 0
SEALS (Randwick)
Prince of Wales Hospital
Barker Street
Sydney, NSW, AUSTRALIA. 2031
Country 35152 0
Australia
Phone 35152 0
+61 2 9562 5342
Fax 35152 0
Email 35152 0
[email protected]
Contact person for public queries
Name 9205 0
Dr Dr Timothy Brighton
Address 9205 0
ASPIRE Study
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 9205 0
Australia
Phone 9205 0
+61 2 95625342
Fax 9205 0
+61 2 95625094
Email 9205 0
[email protected]
Contact person for scientific queries
Name 133 0
Prof John Simes
Address 133 0
ASPIRE Study
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 133 0
Australia
Phone 133 0
+61 2 95625342
Fax 133 0
+61 2 95625094
Email 133 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSecondary prevention of recurrent venous thromboembolism after initial oral anticoagulation therapy in patients with unprovoked venous thromboembolism.2017https://dx.doi.org/10.1002/14651858.CD011088.pub2
N.B. These documents automatically identified may not have been verified by the study sponsor.